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A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT

Primary Purpose

Anaplastic Kidney Wilms Tumor, Recurrent Kidney Wilms Tumor, Stage II Kidney Wilms Tumor

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Biopsy
Biospecimen Collection
Bone Scan
Carboplatin
Computed Tomography
Cyclophosphamide
Doxorubicin
Etoposide
Ifosfamide
Irinotecan
Magnetic Resonance Imaging
Positron Emission Tomography
Radiation Therapy
Surgical Procedure
Topotecan
Transabdominal Ultrasound
Vincristine
X-Ray Imaging
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaplastic Kidney Wilms Tumor

Eligibility Criteria

undefined - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN03B2 and have received an initial risk assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a delayed nephrectomy classification showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on AREN03B2 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor.
  • Patients must be =< 30 years old at study enrollment

  • Patients with the following diagnoses are eligible for this study:

    • Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review

    • Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defined as follows, regardless of radiation therapy:

      • Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine
      • High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan
      • Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations

  • Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required

    • Note: For relapsed FHWT patients, an institutional pathology report confirming favorable histology Wilms tumor (from relapse, if available, or from original diagnosis) must be available for upload prior to initiation of protocol therapy
  • Patients with newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN1921 within 2 weeks of the tumor-directed surgery or biopsy procedure that first confirms a diagnosis of DAWT, whether at initial diagnostic procedure or delayed nephrectomy (such surgery/biopsy is day 0). For patients who received prior therapy for presumed favorable histology Wilms tumor, later confirmed to have diffuse anaplastic Wilms tumor at subsequent review of the initial biopsy
  • Patients with newly diagnosed DAWT who undergo upfront nephrectomy must have at least 1 lymph node sampled prior to study enrollment
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Patients must have a life expectancy of >= 8 weeks

  • Diffuse Anaplastic Wilms Tumor: Patients with diffuse anaplastic histology must have had no prior systemic therapy, except in the following situations:

    • Patients with diffuse anaplastic Wilms tumor who received no more than 12 weeks of pre nephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor, subsequently confirmed to be diffuse anaplastic Wilms tumor at delayed nephrectomy
    • Patients with diffuse anaplastic Wilms tumor who received no more than 6 weeks of chemotherapy following upfront biopsy, initiated within 14 days of biopsy, for presumed favorable histology Wilms tumor based on institutional review, but subsequently corrected to diffuse anaplastic Wilms tumor based on the AREN03B2 initial risk assignment results (if available per current version of AREN03B2)
    • Treatment consisting of vincristine/doxorubicin/cyclophosphamide initiated on an emergent basis and within allowed timing as described
    • Note: Patients who received prior therapy for presumed favorable histology Wilms tumor, later identified to have diffuse anaplastic Wilms tumor as per above, must begin study treatment starting at cycle 3 (week 7) of regimen UH 3. Patients who received emergency radiation to preserve organ function are eligible as noted. Patients who received radiation as part of standard of care for presumed newly diagnosed favorable histology Wilms tumor, along with chemotherapy as noted above, prior to identification of diffuse anaplasia, are also eligible

  • Relapsed Favorable Histology Wilms Tumor: Patients must not have received prior chemotherapy for their relapsed favorable histology Wilms tumor diagnosis. In addition, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

    • Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study
    • Radiation therapy (RT): >= 2 weeks (wks) must have elapsed for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial bone marrow (BM) radiation. Patients with relapsed favorable histology Wilms tumor who received emergency radiation to preserve organ function are eligible and do not need to washout with the above criteria
  • Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)
  • Peripheral absolute neutrophil count (ANC) >= 750/uL (performed within 7 days prior to enrollment)
  • Platelet count >= 75,000/uL (transfusion independent) (performed within 7 days prior to enrollment)
  • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (performed within 7 days prior to enrollment)

  • Patients with high-risk or very high-risk relapsed FHWT who will be treated with regimen ICE/Cyclo/Topo, must have renal function assessed by creatinine clearance or radioisotope glomerular filtration rate (GFR) and meet the following requirement:

    • Creatinine clearance or radioisotope GFR >= 60 mL/min/1.73 m^2 (performed within 7 days prior to enrollment)

  • Patients diagnosed with stage 2-4 DAWT or standard risk relapsed FHWT, who will be treated with regimen UH 3, may either obtain a creatinine clearance, radioisotope GFR (meeting the above criteria of GFR >= 60 mL/min/1.73 m^2), or an adequate serum creatinine as per the following table:

    • Age: Maximum Serum Creatinine (mg/dL)
    • 1 month to < 6 months: 0.4 (male and female)
    • 6 months to < 1 year: 0.5 (male and female)
    • 1 to < 2 years: 0.6 (male and female)
    • 2 to < 6 years: 0.8 (male and female)
    • 6 to < 10 years: 1 (male and female)
    • 10 to < 13 years: 1.2 (male and female)
    • 13 to < 16 years: 1.5 (male), 1.4 (female)
    • >= 16 years: 1.7 (male), 1.4 (female)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age or direct bilirubin =< ULN for patients whose total bilirubin > 1.5 x ULN (performed within 7 days prior to enrollment)
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age or =< 5 x ULN for patients with liver metastases (performed within 7 days prior to enrollment)
  • Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram (obtained within 21 days prior to enrollment and start of protocol therapy)

Exclusion Criteria:

  • Patients with a history of bilateral Wilms tumor (synchronous or metachronous)
  • Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure (defined as grade 2 or higher heart failure per Common Terminology Criteria for Adverse Events [CTCAE] version 5.0)
  • Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy

  • For patients with high-risk or very high-risk relapsed FHWT:

    • Patients with renal tubular acidosis (RTA) as evidenced by serum bicarbonate < 16 mmol/L and serum phosphate =< 2 mg/dL (or < 0.8 mmol/L) without supplementation

  • For stages 2-4 DAWT and standard-risk relapsed FHWT patients:

    • Chronic inflammatory bowel disease and/or bowel obstruction
    • Concomitant use of St. John's wort, which cannot be stopped prior to the start of trial treatment
  • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
  • Lactating females who plan to breastfeed their infants
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

Sites / Locations

  • Children's Hospital of AlabamaRecruiting
  • USA Health Strada Patient Care CenterRecruiting
  • Providence Alaska Medical CenterRecruiting
  • Banner Children's at DesertRecruiting
  • Banner University Medical Center - TucsonRecruiting
  • Arkansas Children's HospitalRecruiting
  • Kaiser Permanente Downey Medical CenterRecruiting
  • Loma Linda University Medical CenterRecruiting
  • Miller Children's and Women's Hospital Long BeachRecruiting
  • Children's Hospital Los AngelesRecruiting
  • Mattel Children's Hospital UCLARecruiting
  • Valley Children's HospitalRecruiting
  • UCSF Benioff Children's Hospital OaklandRecruiting
  • Kaiser Permanente-OaklandRecruiting
  • Children's Hospital of Orange CountyRecruiting
  • Lucile Packard Children's Hospital Stanford UniversityRecruiting
  • University of California Davis Comprehensive Cancer CenterRecruiting
  • Rady Children's Hospital - San DiegoRecruiting
  • UCSF Medical Center-Mission BayRecruiting
  • Children's Hospital ColoradoRecruiting
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterRecruiting
  • Connecticut Children's Medical CenterRecruiting
  • Yale UniversityRecruiting
  • Alfred I duPont Hospital for ChildrenRecruiting
  • MedStar Georgetown University HospitalRecruiting
  • Children's National Medical CenterRecruiting
  • Golisano Children's Hospital of Southwest FloridaRecruiting
  • University of Florida Health Science Center - GainesvilleRecruiting
  • Memorial Regional Hospital/Joe DiMaggio Children's HospitalRecruiting
  • Nemours Children's Clinic-JacksonvilleRecruiting
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Nicklaus Children's HospitalRecruiting
  • Arnold Palmer Hospital for ChildrenRecruiting
  • Nemours Children's HospitalRecruiting
  • Sacred Heart HospitalRecruiting
  • Johns Hopkins All Children's HospitalRecruiting
  • Tampa General HospitalRecruiting
  • Saint Joseph's Hospital/Children's Hospital-TampaRecruiting
  • Saint Mary's HospitalRecruiting
  • Children's Healthcare of Atlanta - EglestonRecruiting
  • Medical Center of Central GeorgiaRecruiting
  • Memorial Health University Medical CenterRecruiting
  • Kapiolani Medical Center for Women and ChildrenRecruiting
  • Saint Luke's Cancer Institute - BoiseRecruiting
  • Lurie Children's Hospital-ChicagoRecruiting
  • University of IllinoisRecruiting
  • University of Chicago Comprehensive Cancer CenterRecruiting
  • Loyola University Medical CenterRecruiting
  • Advocate Children's Hospital-Oak LawnRecruiting
  • Advocate Children's Hospital-Park RidgeRecruiting
  • Saint Jude Midwest AffiliateRecruiting
  • Southern Illinois University School of MedicineRecruiting
  • Riley Hospital for ChildrenRecruiting
  • Blank Children's HospitalRecruiting
  • University of Iowa/Holden Comprehensive Cancer CenterRecruiting
  • University of Kentucky/Markey Cancer CenterRecruiting
  • Norton Children's HospitalRecruiting
  • Children's Hospital New OrleansRecruiting
  • Ochsner Medical Center JeffersonRecruiting
  • Eastern Maine Medical Center
  • Maine Children's Cancer ProgramRecruiting
  • Sinai Hospital of BaltimoreRecruiting
  • Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
  • Tufts Children's Hospital
  • Dana-Farber Cancer InstituteRecruiting
  • UMass Memorial Medical Center - University CampusRecruiting
  • C S Mott Children's HospitalRecruiting
  • Children's Hospital of MichiganRecruiting
  • Michigan State University Clinical CenterRecruiting
  • Helen DeVos Children's Hospital at Spectrum HealthRecruiting
  • Bronson Methodist HospitalRecruiting
  • Beaumont Children's Hospital-Royal OakRecruiting
  • Children's Hospitals and Clinics of Minnesota - MinneapolisRecruiting
  • University of Minnesota/Masonic Cancer CenterRecruiting
  • Mayo Clinic in RochesterRecruiting
  • University of Mississippi Medical CenterRecruiting
  • Columbia RegionalRecruiting
  • Children's Mercy Hospitals and ClinicsRecruiting
  • Cardinal Glennon Children's Medical CenterRecruiting
  • Washington University School of MedicineRecruiting
  • Mercy Hospital Saint LouisRecruiting
  • Children's Hospital and Medical Center of OmahaRecruiting
  • University of Nebraska Medical CenterRecruiting
  • University Medical Center of Southern NevadaRecruiting
  • Sunrise Hospital and Medical CenterRecruiting
  • Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
  • Summerlin Hospital Medical CenterRecruiting
  • Renown Regional Medical CenterRecruiting
  • Hackensack University Medical CenterRecruiting
  • Morristown Medical CenterRecruiting
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalRecruiting
  • Saint Joseph's Regional Medical CenterRecruiting
  • Albany Medical CenterRecruiting
  • Montefiore Medical Center - Moses CampusRecruiting
  • Roswell Park Cancer InstituteRecruiting
  • The Steven and Alexandra Cohen Children's Medical Center of New YorkRecruiting
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • NYP/Weill Cornell Medical CenterRecruiting
  • Stony Brook University Medical CenterRecruiting
  • State University of New York Upstate Medical UniversityRecruiting
  • New York Medical CollegeRecruiting
  • Mission HospitalRecruiting
  • Carolinas Medical Center/Levine Cancer InstituteRecruiting
  • Novant Health Presbyterian Medical CenterRecruiting
  • Duke University Medical CenterRecruiting
  • East Carolina UniversityRecruiting
  • Wake Forest University Health SciencesRecruiting
  • Sanford Broadway Medical CenterRecruiting
  • Children's Hospital Medical Center of AkronRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Rainbow Babies and Childrens HospitalRecruiting
  • Cleveland Clinic FoundationRecruiting
  • Nationwide Children's HospitalRecruiting
  • Dayton Children's HospitalRecruiting
  • ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalRecruiting
  • University of Oklahoma Health Sciences CenterRecruiting
  • Legacy Emanuel Children's HospitalRecruiting
  • Oregon Health and Science UniversityRecruiting
  • Lehigh Valley Hospital-Cedar CrestRecruiting
  • Geisinger Medical CenterRecruiting
  • Penn State Children's HospitalRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Saint Christopher's Hospital for ChildrenRecruiting
  • Children's Hospital of Pittsburgh of UPMCRecruiting
  • Rhode Island HospitalRecruiting
  • Medical University of South CarolinaRecruiting
  • Prisma Health Richland HospitalRecruiting
  • BI-LO Charities Children's Cancer CenterRecruiting
  • Sanford USD Medical Center - Sioux FallsRecruiting
  • T C Thompson Children's HospitalRecruiting
  • East Tennessee Childrens HospitalRecruiting
  • Saint Jude Children's Research HospitalRecruiting
  • The Children's Hospital at TriStar CentennialRecruiting
  • Vanderbilt University/Ingram Cancer CenterRecruiting
  • Texas Tech University Health Sciences Center-AmarilloRecruiting
  • Dell Children's Medical Center of Central TexasRecruiting
  • Driscoll Children's HospitalRecruiting
  • Medical City Dallas HospitalRecruiting
  • UT Southwestern/Simmons Cancer Center-DallasRecruiting
  • El Paso Children's HospitalRecruiting
  • Cook Children's Medical CenterRecruiting
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
  • M D Anderson Cancer CenterRecruiting
  • Covenant Children's HospitalRecruiting
  • UMC Cancer Center / UMC Health SystemRecruiting
  • Children's Hospital of San AntonioRecruiting
  • Methodist Children's Hospital of South TexasRecruiting
  • University of Texas Health Science Center at San AntonioRecruiting
  • Primary Children's HospitalRecruiting
  • University of Virginia Cancer CenterRecruiting
  • Inova Fairfax HospitalRecruiting
  • Children's Hospital of The King's DaughtersRecruiting
  • Virginia Commonwealth University/Massey Cancer CenterRecruiting
  • Carilion Children'sRecruiting
  • Seattle Children's HospitalRecruiting
  • Providence Sacred Heart Medical Center and Children's HospitalRecruiting
  • Mary Bridge Children's Hospital and Health CenterRecruiting
  • Madigan Army Medical CenterRecruiting
  • West Virginia University Charleston DivisionRecruiting
  • Edwards Comprehensive Cancer CenterRecruiting
  • University of Wisconsin Carbone Cancer CenterRecruiting
  • Marshfield Medical Center-MarshfieldRecruiting
  • Children's Hospital of WisconsinRecruiting
  • John Hunter Children's HospitalRecruiting
  • Sydney Children's HospitalRecruiting
  • The Children's Hospital at WestmeadRecruiting
  • Queensland Children's HospitalRecruiting
  • Women's and Children's Hospital-AdelaideRecruiting
  • Monash Medical Center-Clayton Campus
  • Royal Children's HospitalRecruiting
  • Perth Children's HospitalRecruiting
  • Alberta Children's HospitalRecruiting
  • University of Alberta HospitalRecruiting
  • British Columbia Children's HospitalRecruiting
  • CancerCare ManitobaRecruiting
  • Janeway Child Health CentreRecruiting
  • IWK Health CentreRecruiting
  • McMaster Children's Hospital at Hamilton Health SciencesRecruiting
  • Children's HospitalRecruiting
  • Children's Hospital of Eastern OntarioRecruiting
  • Hospital for Sick ChildrenRecruiting
  • The Montreal Children's Hospital of the MUHCRecruiting
  • Centre Hospitalier Universitaire Sainte-JustineRecruiting
  • Centre Hospitalier Universitaire de Sherbrooke-FleurimontRecruiting
  • Centre Hospitalier Universitaire de QuebecRecruiting
  • Starship Children's HospitalRecruiting
  • Christchurch HospitalRecruiting
  • HIMA San Pablo Oncologic HospitalRecruiting
  • University Pediatric HospitalRecruiting
  • King Faisal Specialist Hospital and Research CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (Regimen UH-3)

Arm II (Regimen ICE/Cyclo/Topo)

Arm Description

See outline in detailed description section.

CYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.

Outcomes

Primary Outcome Measures

Event-free survival (EFS)
For Strata 1-3, the primary analysis of EFS will consist of a one-sample, one-sided log rank test versus a historical control cohort (or representative distribution) with stratum-specific type I error levels. For Stratum 4, the primary analysis of EFS is descriptive, but with a desired level of precision to estimate 4-year EFS at the time of the final analysis (2 years after the last patient enrolls).

Secondary Outcome Measures

Overall survival (OS)
For each stratum, OS will be estimated at the same time as the conclusive (interim or final) analysis and reported descriptively with 95% pointwise confidence bands.

Full Information

First Posted
March 17, 2020
Last Updated
September 13, 2023
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04322318
Brief Title
A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
Official Title
Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
July 1, 2027 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/ carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the event-free survival (EFS) of patients with newly diagnosed stage 4 diffuse anaplastic Wilms tumor (DAWT) as compared to historical controls. II. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the EFS of patients with standard-risk relapsed favorable histology Wilms tumor (SRrFHWT) as compared to historical controls. SECONDARY OBJECTIVES: I. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the overall survival (OS) of patients with newly diagnosed stage 4 DAWT as compared to historical controls. II. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the OS of patients with SRrFHWT as compared to historical controls. III. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the EFS and OS of patients with newly diagnosed stage 2 and 3 DAWT as compared to historical controls. IV. To establish EFS and OS for high-risk (HRrFHWT) and very high risk (VHRrFHWT) relapsed favorable histology Wilms tumor treated with ifosfamide/carboplatin/etoposide alternating with cyclophosphamide/ topotecan. EXPLORATORY OBJECTIVES: I. To describe renal toxicity of ifosfamide/carboplatin/etoposide in HRrFHWT and VHRrFHWT patients using conventional and novel biomarkers of renal toxicity (urine NGAL, cystatin C and Kim1) in the context of the chemotherapy regimens used on this study. II. To collect and bank serial blood and urine samples in patients with newly diagnosed DAWT or relapsed FHWT and tumor tissue in patients with relapsed FHWT, for future analysis. III. To assess the impact of p53 gene and protein expression on outcome for patients with newly diagnosed DAWT. IV. To determine EFS/OS in the subsets of patients with newly diagnosed DAWT or relapsed FWHT who undergo gross total resection at all disease sites at diagnosis or after neoadjuvant chemotherapy. V. To describe the rate of regional lymph node sampling at the time of nephrectomy with the use of a pre-operative surgical checklist for patients with newly diagnosed DAWT. VI. To determine the feasibility of intensity modulated radiation therapy (IMRT) with central quality assurance (QA) monitoring to reduce radiation induced toxicity to the heart, thyroid, breast and solitary kidney for children with lung and liver metastases (part of an overarching aim in this study and across frontline favorable histology Wilms tumor studies). OUTLINE: Patients are assigned to 1 of 2 arms. ARM I (REGIMEN UH-3): CYCLES 1, 5, 7, 10, AND 13: Patients receive vincristine intravenously (IV) via minibag per institutional policy on days 1, 8, and 15. Patients also receive doxorubicin IV over 1-15 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days during cycles 1, 5, 7, 10, and 13 in the absence of disease progression or unacceptable toxicity. CYCLES 2, 6, 9, 12, AND 14: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive cyclophosphamide IV over 15-30 minutes and etoposide IV over 1-2 hours on days 1-4. Treatment repeats every 21 days during cycles 2, 6, 9, 12, and 14 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 4, 8, AND 11: Patients receive vincristine IV via minibag per institutional policy on days 1 and 8 and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 4, 8, and 11 in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy (RT) at week 7 of cycle 3 as clinically indicated. Patients undergo a computed tomography (CT) scan, a positron emission tomography (PET) scan, a chest x-ray, magnetic resonance imaging (MRI), an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial. ARM II (REGIMEN IFOSFAMIDE, CARBOPLATIN, ETOPOSIDE [ICE]/CYCLOPHOSPHAMIDE [CYCLO]/TOPOTECAN [TOPO]): CYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial. After completion of study treatment, patients are followed up every 3 months for years 1-2, every 6 months for years 3-4, and once at year 5.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Kidney Wilms Tumor, Recurrent Kidney Wilms Tumor, Stage II Kidney Wilms Tumor, Stage III Kidney Wilms Tumor, Stage IV Kidney Wilms Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
221 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (Regimen UH-3)
Arm Type
Experimental
Arm Description
See outline in detailed description section.
Arm Title
Arm II (Regimen ICE/Cyclo/Topo)
Arm Type
Experimental
Arm Description
CYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Other Intervention Name(s)
BIOPSY_TYPE, Bx
Intervention Description
Undergo a biopsy
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo blood sample collection
Intervention Type
Procedure
Intervention Name(s)
Bone Scan
Other Intervention Name(s)
Bone Scintigraphy
Intervention Description
Undergo a bone scan
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo a CT scan
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
(-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP-16, VP-16-213, VP16
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Other Intervention Name(s)
Asta Z 4942, Asta Z-4942, Cyfos, Holoxan, Holoxane, Ifex, IFO, IFO-Cell, Ifolem, Ifomida, Ifomide, Ifosfamidum, Ifoxan, IFX, Iphosphamid, Iphosphamide, Iso-Endoxan, Isoendoxan, Isophosphamide, Mitoxana, MJF 9325, MJF-9325, Naxamide, Seromida, Tronoxal, Z 4942, Z-4942
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Intervention Description
Undergo a PET scan
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo RT
Intervention Type
Procedure
Intervention Name(s)
Surgical Procedure
Other Intervention Name(s)
Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery
Intervention Description
Undergo surgery
Intervention Type
Drug
Intervention Name(s)
Topotecan
Other Intervention Name(s)
Hycamptamine, Topotecan Lactone
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Transabdominal Ultrasound
Other Intervention Name(s)
abdominal ultrasound, TUS
Intervention Description
Undergo abdominal ultrasound
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
Leurocristine, VCR, Vincrystine
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
X-Ray Imaging
Other Intervention Name(s)
Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs, Radiographic Imaging, Radiographic imaging procedure (procedure), Radiography, RG, Static X-Ray, X-Ray
Intervention Description
Undergo a chest x-ray
Primary Outcome Measure Information:
Title
Event-free survival (EFS)
Description
For Strata 1-3, the primary analysis of EFS will consist of a one-sample, one-sided log rank test versus a historical control cohort (or representative distribution) with stratum-specific type I error levels. For Stratum 4, the primary analysis of EFS is descriptive, but with a desired level of precision to estimate 4-year EFS at the time of the final analysis (2 years after the last patient enrolls).
Time Frame
From study entry to the earliest of relapse or disease progression, second malignant neoplasm, or death from any cause, assessed up to 5 years after study enrollment
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
For each stratum, OS will be estimated at the same time as the conclusive (interim or final) analysis and reported descriptively with 95% pointwise confidence bands.
Time Frame
From study entry to death due to any cause, assessed up to 5 years after study enrollment
Other Pre-specified Outcome Measures:
Title
Incidence of grade 3-5 renal toxicity
Description
Incidence of grade 3-5 renal toxicity during protocol therapy will be monitored for Stratum 4 as part of a prospective safety monitoring plan. At the time of final study analysis, renal toxicity will be described by factors including age, relapse risk group, and timing and association (descriptive) with the exploratory renal toxicity biomarkers.
Time Frame
Up to 30 weeks on average for Stratum 4 only
Title
Collection of blood and urine samples
Description
For all Strata 1-4, serial blood and urine samples will be collected (during protocol therapy, at the end of protocol therapy, and at first relapse) and banked for future analysis such as evaluation of minimal residual disease by assessing levels of circulating tumor-derived deoxyribonucleic acid.
Time Frame
Up to 42 weeks on average for Strata 1-3 and up to 30 weeks on average for Stratum 4
Title
p53 biomarker analysis
Description
For patients with diffuse anaplastic Wilms tumors (DAWT) (Strata 1 and 2), p53 from diagnostic tissue will be assessed, and rates of p53 mutations described overall and within each stratum. Degree of anaplasia as a predictor of p53 mutation status will be analyzed in logistic regression models, and association of p53 status with EFS and OS will be analyzed in Cox regression models, stratified by disease stage. Possible interactions between p53 mutation status and degree of anaplasia in outcome models will be explored.
Time Frame
Based on tissue collected at diagnosis (Strata 1 and 2 only), with outcomes collected up to 5 years after study entry
Title
EFS for patients with gross total disease resection
Description
EFS will be described for newly diagnosed disease stage 2-4 DAWT patients (Strata 1 and 2) and relapsed favorable histology Wilms tumors (FHWT) patients (Strata 3 and 4) who have gross total disease resection prior to enrollment or at the time of delayed nephrectomy following adjuvant chemotherapy. Kaplan-Meier curves will be reported by strata with 95% confidence bands. Potential prognostic factors for these patients will be explored in Cox regression models.
Time Frame
From study entry to the earliest of relapse or disease progression, second malignant neoplasm, or death from any cause, assessed up to 5 years after study enrollment
Title
OS for patients with gross total disease resection
Description
OS will be described for newly diagnosed disease stage 2-4 DAWT patients (Strata 1 and 2) and relapsed FHWT patients (Strata 3 and 4) who have gross total disease resection prior to enrollment or at the time of delayed nephrectomy following adjuvant chemotherapy. Kaplan-Meier curves will be reported by strata with 95% confidence bands. Potential prognostic factors for these patients will be explored in Cox regression models.
Time Frame
From study entry to death due to any cause, assessed up to 5 years after study entry
Title
Association of the number of nodes examined with EFS and OS
Description
The number of lymph nodes examined at the time of primary nephrectomy and number of positive nodes will be collected for all DAWT patients who enroll to Strata 1 or 2. The association of the number of nodes examined with EFS and OS will be explored in Cox regression models stratified by disease stage. For each of these analyses, association will be expressed either as a single hazard ratio if the effect is found to be linear, or as continuous functions on the hazard ratio scale if the effect is found to be non-linear. Similar models will be fit to examine the association between ratio of positive nodes to nodes examined and outcomes. Confidence intervals or bands will be reported for all quantities.
Time Frame
Nodal information from upfront or delayed nephrectomy, with outcomes collected for up to 5 years after study entry

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN03B2 and have received an initial risk assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a delayed nephrectomy classification showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on AREN03B2 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor. Patients must be =< 30 years old at study enrollment Patients with the following diagnoses are eligible for this study: Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defined as follows, regardless of radiation therapy: Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required Note: For relapsed FHWT patients, an institutional pathology report confirming favorable histology Wilms tumor (from relapse, if available, or from original diagnosis) must be available for upload prior to initiation of protocol therapy Patients with newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN1921 within 2 weeks of the tumor-directed surgery or biopsy procedure that first confirms a diagnosis of DAWT, whether at initial diagnostic procedure or delayed nephrectomy (such surgery/biopsy is day 0). For patients who received prior therapy for presumed favorable histology Wilms tumor, later confirmed to have diffuse anaplastic Wilms tumor at subsequent review of the initial biopsy Patients with newly diagnosed DAWT who undergo upfront nephrectomy must have at least 1 lymph node sampled prior to study enrollment Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have a life expectancy of >= 8 weeks Diffuse Anaplastic Wilms Tumor: Patients with diffuse anaplastic histology must have had no prior systemic therapy, except in the following situations: Patients with diffuse anaplastic Wilms tumor who received no more than 12 weeks of pre nephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor, subsequently confirmed to be diffuse anaplastic Wilms tumor at delayed nephrectomy Patients with diffuse anaplastic Wilms tumor who received no more than 6 weeks of chemotherapy following upfront biopsy, initiated within 14 days of biopsy, for presumed favorable histology Wilms tumor based on institutional review, but subsequently corrected to diffuse anaplastic Wilms tumor based on the AREN03B2 initial risk assignment results (if available per current version of AREN03B2) Treatment consisting of vincristine/doxorubicin/cyclophosphamide initiated on an emergent basis and within allowed timing as described Note: Patients who received prior therapy for presumed favorable histology Wilms tumor, later identified to have diffuse anaplastic Wilms tumor as per above, must begin study treatment starting at cycle 3 (week 7) of regimen UH 3. Patients who received emergency radiation to preserve organ function are eligible as noted. Patients who received radiation as part of standard of care for presumed newly diagnosed favorable histology Wilms tumor, along with chemotherapy as noted above, prior to identification of diffuse anaplasia, are also eligible Relapsed Favorable Histology Wilms Tumor: Patients must not have received prior chemotherapy for their relapsed favorable histology Wilms tumor diagnosis. In addition, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study Radiation therapy (RT): >= 2 weeks (wks) must have elapsed for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial bone marrow (BM) radiation. Patients with relapsed favorable histology Wilms tumor who received emergency radiation to preserve organ function are eligible and do not need to washout with the above criteria Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment) Peripheral absolute neutrophil count (ANC) >= 750/uL (performed within 7 days prior to enrollment) Platelet count >= 75,000/uL (transfusion independent) (performed within 7 days prior to enrollment) Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (performed within 7 days prior to enrollment) Patients with high-risk or very high-risk relapsed FHWT who will be treated with regimen ICE/Cyclo/Topo, must have renal function assessed by creatinine clearance or radioisotope glomerular filtration rate (GFR) and meet the following requirement: Creatinine clearance or radioisotope GFR >= 60 mL/min/1.73 m^2 (performed within 7 days prior to enrollment) Patients diagnosed with stage 2-4 DAWT or standard risk relapsed FHWT, who will be treated with regimen UH 3, may either obtain a creatinine clearance, radioisotope GFR (meeting the above criteria of GFR >= 60 mL/min/1.73 m^2), or an adequate serum creatinine as per the following table: Age: Maximum Serum Creatinine (mg/dL) 1 month to < 6 months: 0.4 (male and female) 6 months to < 1 year: 0.5 (male and female) 1 to < 2 years: 0.6 (male and female) 2 to < 6 years: 0.8 (male and female) 6 to < 10 years: 1 (male and female) 10 to < 13 years: 1.2 (male and female) 13 to < 16 years: 1.5 (male), 1.4 (female) >= 16 years: 1.7 (male), 1.4 (female) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age or direct bilirubin =< ULN for patients whose total bilirubin > 1.5 x ULN (performed within 7 days prior to enrollment) Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age or =< 5 x ULN for patients with liver metastases (performed within 7 days prior to enrollment) Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram (obtained within 21 days prior to enrollment and start of protocol therapy) Exclusion Criteria: Patients with a history of bilateral Wilms tumor (synchronous or metachronous) Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure (defined as grade 2 or higher heart failure per Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy For patients with high-risk or very high-risk relapsed FHWT: Patients with renal tubular acidosis (RTA) as evidenced by serum bicarbonate < 16 mmol/L and serum phosphate =< 2 mg/dL (or < 0.8 mmol/L) without supplementation For stages 2-4 DAWT and standard-risk relapsed FHWT patients: Chronic inflammatory bowel disease and/or bowel obstruction Concomitant use of St. John's wort, which cannot be stopped prior to the start of trial treatment Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential Lactating females who plan to breastfeed their infants Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James I Geller
Organizational Affiliation
Children's Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
205-638-9285
Email
oncologyresearch@peds.uab.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth D. Alva
Facility Name
USA Health Strada Patient Care Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-388-8721
First Name & Middle Initial & Last Name & Degree
Hamayun Imran
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
907-212-6871
Email
AKPAMC.OncologyResearchSupport@providence.org
First Name & Middle Initial & Last Name & Degree
Brenda J. Wittman
Facility Name
Banner Children's at Desert
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
480-412-3100
First Name & Middle Initial & Last Name & Degree
Joseph C. Torkildson
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
UACC-IIT@uacc.arizona.edu
First Name & Middle Initial & Last Name & Degree
Michelina de la Maza
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202-3591
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
501-364-7373
First Name & Middle Initial & Last Name & Degree
David L. Becton
Facility Name
Kaiser Permanente Downey Medical Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
626-564-3455
First Name & Middle Initial & Last Name & Degree
Neha G. Vaghasia
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
909-558-4050
First Name & Middle Initial & Last Name & Degree
Albert Kheradpour
Facility Name
Miller Children's and Women's Hospital Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
562-933-5600
First Name & Middle Initial & Last Name & Degree
Jacqueline N. Casillas
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
323-361-4110
First Name & Middle Initial & Last Name & Degree
Leo Mascarenhas
Facility Name
Mattel Children's Hospital UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
310-825-6708
First Name & Middle Initial & Last Name & Degree
Noah C. Federman
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
559-353-3000
Email
Research@valleychildrens.org
First Name & Middle Initial & Last Name & Degree
Karen S. Fernandez
Facility Name
UCSF Benioff Children's Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
510-428-3324
Email
Carla.Golden@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Carla B. Golden
Facility Name
Kaiser Permanente-Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Aarati V. Rao
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
714-509-8646
Email
oncresearch@choc.org
First Name & Middle Initial & Last Name & Degree
Elyssa M. Rubin
Facility Name
Lucile Packard Children's Hospital Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-694-0012
Email
ccto-office@stanford.edu
First Name & Middle Initial & Last Name & Degree
Jay Michael S. Balagtas
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
916-734-3089
First Name & Middle Initial & Last Name & Degree
Marcio H. Malogolowkin
Facility Name
Rady Children's Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
858-966-5934
First Name & Middle Initial & Last Name & Degree
William D. Roberts
Facility Name
UCSF Medical Center-Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-827-3222
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Arun A. Rangaswami
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
303-764-5056
Email
josh.b.gordon@nsmtp.kp.org
First Name & Middle Initial & Last Name & Degree
Timothy P. Garrington
Facility Name
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
303-839-6000
First Name & Middle Initial & Last Name & Degree
Jennifer J. Clark
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
860-545-9981
First Name & Middle Initial & Last Name & Degree
Michael S. Isakoff
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Farzana Pashankar
Facility Name
Alfred I duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-651-5572
Email
Allison.bruce@nemours.org
First Name & Middle Initial & Last Name & Degree
Ramamoorthy Nagasubramanian
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
202-444-2223
First Name & Middle Initial & Last Name & Degree
Nina S. Kadan-Lottick
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
202-884-2549
First Name & Middle Initial & Last Name & Degree
Jeffrey S. Dome
Facility Name
Golisano Children's Hospital of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
239-343-5333
Email
molly.arnstrom@leehealth.org
First Name & Middle Initial & Last Name & Degree
Emad K. Salman
Facility Name
University of Florida Health Science Center - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
352-273-8010
Email
cancer-center@ufl.edu
First Name & Middle Initial & Last Name & Degree
William B. Slayton
Facility Name
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
954-265-1847
Email
OHR@mhs.net
First Name & Middle Initial & Last Name & Degree
Iftikhar Hanif
Facility Name
Nemours Children's Clinic-Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-651-5572
Email
Allison.bruce@nemours.org
First Name & Middle Initial & Last Name & Degree
Ramamoorthy Nagasubramanian
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-624-2778
First Name & Middle Initial & Last Name & Degree
Maggie E. Fader
Facility Name
Arnold Palmer Hospital for Children
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
321-841-5357
Email
Jennifer.spinelli@orlandohealth.com
First Name & Middle Initial & Last Name & Degree
Amy A. Smith
Facility Name
Nemours Children's Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-651-5572
Email
Allison.bruce@nemours.org
First Name & Middle Initial & Last Name & Degree
Ramamoorthy Nagasubramanian
Facility Name
Sacred Heart Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
850-416-4611
Email
eebrou@ascension.org
First Name & Middle Initial & Last Name & Degree
Erlyn C. Smith
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
727-767-4784
Email
Ashley.Repp@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Jonathan L. Metts
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
813-844-7829
Email
syapchanyk@tgh.org
First Name & Middle Initial & Last Name & Degree
Andrew J. Galligan
Facility Name
Saint Joseph's Hospital/Children's Hospital-Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
813-357-0849
Email
jennifer.manns@baycare.org
First Name & Middle Initial & Last Name & Degree
Don E. Eslin
Facility Name
Saint Mary's Hospital
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
561-881-2815
First Name & Middle Initial & Last Name & Degree
Muaz A. Alrazzak
Facility Name
Children's Healthcare of Atlanta - Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
404-785-2025
Email
Leann.Schilling@choa.org
First Name & Middle Initial & Last Name & Degree
Andrew L. Hong
Facility Name
Medical Center of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
478-633-2152
Email
andrew.weatherall@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Sushmita Nair
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
912-350-7887
Email
Lorraine.OHara@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Andrew L. Pendleton
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
808-983-6090
First Name & Middle Initial & Last Name & Degree
Wade T. Kyono
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Martha M. Pacheco
Facility Name
Lurie Children's Hospital-Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-880-4562
First Name & Middle Initial & Last Name & Degree
Amy L. Walz
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
312-355-3046
First Name & Middle Initial & Last Name & Degree
Mary L. Schmidt
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Ami V. Desai
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
708-226-4357
First Name & Middle Initial & Last Name & Degree
Eugene Suh
Facility Name
Advocate Children's Hospital-Oak Lawn
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
847-723-7570
First Name & Middle Initial & Last Name & Degree
Rebecca E. McFall
Facility Name
Advocate Children's Hospital-Park Ridge
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
helpdesk@childrensoncologygroup.org
First Name & Middle Initial & Last Name & Degree
Rebecca E. McFall
Facility Name
Saint Jude Midwest Affiliate
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-226-4343
First Name & Middle Initial & Last Name & Degree
Prerna Kumar
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-545-7929
First Name & Middle Initial & Last Name & Degree
Gregory P. Brandt
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-248-1199
First Name & Middle Initial & Last Name & Degree
Melissa K. Bear
Facility Name
Blank Children's Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-241-8912
Email
samantha.mallory@unitypoint.org
First Name & Middle Initial & Last Name & Degree
Samantha L. Mallory
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-237-1225
First Name & Middle Initial & Last Name & Degree
David S. Dickens
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
859-257-3379
First Name & Middle Initial & Last Name & Degree
James T. Badgett
Facility Name
Norton Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
502-629-5500
Email
CancerResource@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
Ashok B. Raj
Facility Name
Children's Hospital New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
CHResearch@lcmchealth.org
First Name & Middle Initial & Last Name & Degree
Lolie C. Yu
Facility Name
Ochsner Medical Center Jefferson
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
504-842-8084
Email
Elisemarie.curry@ochsner.org
First Name & Middle Initial & Last Name & Degree
Craig Lotterman
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Individual Site Status
Suspended
Facility Name
Maine Children's Cancer Program
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-396-7581
Email
sverwys@mmc.org
First Name & Middle Initial & Last Name & Degree
Aaron R. Weiss
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
410-601-6120
Email
pridgely@lifebridgehealth.org
First Name & Middle Initial & Last Name & Degree
Jason M. Fixler
Facility Name
Johns Hopkins University/Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
410-955-8804
Email
jhcccro@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Alan D. Friedman
Facility Name
Tufts Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-442-3324
First Name & Middle Initial & Last Name & Degree
Elizabeth A. Mullen
Facility Name
UMass Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
508-856-3216
Email
cancer.research@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Stefanie R. Lowas
Facility Name
C S Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-865-1125
First Name & Middle Initial & Last Name & Degree
Rama Jasty
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
helpdesk@childrensoncologygroup.org
First Name & Middle Initial & Last Name & Degree
Alissa M. Martin
Facility Name
Michigan State University Clinical Center
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824-7016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
517-975-9547
First Name & Middle Initial & Last Name & Degree
Laura E. Agresta
Facility Name
Helen DeVos Children's Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
Beaumont Children's Hospital-Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
248-551-7695
First Name & Middle Initial & Last Name & Degree
Laura K. Gowans
Facility Name
Children's Hospitals and Clinics of Minnesota - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
612-813-5193
First Name & Middle Initial & Last Name & Degree
Michael K. Richards
Facility Name
University of Minnesota/Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
612-624-2620
First Name & Middle Initial & Last Name & Degree
Emily G. Greengard
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Wendy Allen-Rhoades
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
601-815-6700
First Name & Middle Initial & Last Name & Degree
Betty L. Herrington
Facility Name
Columbia Regional
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
helpdesk@childrensoncologygroup.org
First Name & Middle Initial & Last Name & Degree
Barbara A. Gruner
Facility Name
Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
816-302-6808
Email
rryan@cmh.edu
First Name & Middle Initial & Last Name & Degree
Keith J. August
Facility Name
Cardinal Glennon Children's Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-268-4000
First Name & Middle Initial & Last Name & Degree
William S. Ferguson
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Amy Armstrong
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-251-7066
First Name & Middle Initial & Last Name & Degree
Robin D. Hanson
Facility Name
Children's Hospital and Medical Center of Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
402-955-3949
First Name & Middle Initial & Last Name & Degree
Jill C. Beck
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
402-559-6941
Email
unmcrsa@unmc.edu
First Name & Middle Initial & Last Name & Degree
Jill C. Beck
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
Alan K. Ikeda
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
Alan K. Ikeda
Facility Name
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
Alan K. Ikeda
Facility Name
Summerlin Hospital Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
Alan K. Ikeda
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
Alan K. Ikeda
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
201-996-2879
First Name & Middle Initial & Last Name & Degree
Katharine Offer
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
973-971-5900
First Name & Middle Initial & Last Name & Degree
Kathryn L. Laurie
Facility Name
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
732-235-8675
First Name & Middle Initial & Last Name & Degree
Scott Moerdler
Facility Name
Saint Joseph's Regional Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
973-754-2207
Email
HallL@sjhmc.org
First Name & Middle Initial & Last Name & Degree
Alissa Kahn
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
518-262-5513
First Name & Middle Initial & Last Name & Degree
Lauren R. Weintraub
Facility Name
Montefiore Medical Center - Moses Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
718-379-6866
Email
eskwak@montefiore.org
First Name & Middle Initial & Last Name & Degree
Lisa Gennarini
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-767-9355
Email
askroswell@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Clare J. Twist
Facility Name
The Steven and Alexandra Cohen Children's Medical Center of New York
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
718-470-3460
First Name & Middle Initial & Last Name & Degree
Carolyn F. Levy
Facility Name
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-305-6361
Email
nr2616@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Nobuko Hijiya
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Michael V. Ortiz
Facility Name
NYP/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-746-1848
First Name & Middle Initial & Last Name & Degree
Lisa G. Roth
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-862-2215
First Name & Middle Initial & Last Name & Degree
Laura E. Hogan
Facility Name
State University of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
315-464-5476
First Name & Middle Initial & Last Name & Degree
Philip M. Monteleone
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
914-594-3794
First Name & Middle Initial & Last Name & Degree
Jessica C. Hochberg
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
828-213-7055
Email
NCDV.ResearchRegulatory@HCAHealthcare.com
First Name & Middle Initial & Last Name & Degree
Douglas J. Scothorn
Facility Name
Carolinas Medical Center/Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-804-9376
First Name & Middle Initial & Last Name & Degree
Joel A. Kaplan
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
980-201-6360
Email
kashah@novanthealth.org
First Name & Middle Initial & Last Name & Degree
Jessica A. Bell
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-275-3853
First Name & Middle Initial & Last Name & Degree
Lars M. Wagner
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
252-744-1015
Email
eubankss@ecu.edu
First Name & Middle Initial & Last Name & Degree
Andrea R. Whitfield
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
336-713-6771
First Name & Middle Initial & Last Name & Degree
Thomas W. McLean
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
701-323-5760
Email
OncologyClinicalTrialsFargo@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Samuel J. Milanovich
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
330-543-3193
First Name & Middle Initial & Last Name & Degree
Erin Wright
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
513-636-2799
Email
cancer@cchmc.org
First Name & Middle Initial & Last Name & Degree
James I. Geller
Facility Name
Rainbow Babies and Childrens Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
216-844-5437
First Name & Middle Initial & Last Name & Degree
Duncan S. Stearns
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
866-223-8100
Email
TaussigResearch@ccf.org
First Name & Middle Initial & Last Name & Degree
Rabi Hanna
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
614-722-6039
Email
Melinda.Triplet@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Mark A. Ranalli
Facility Name
Dayton Children's Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-228-4055
First Name & Middle Initial & Last Name & Degree
Mukund G. Dole
Facility Name
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
419-824-1842
Email
PCIOncResearch@promedica.org
First Name & Middle Initial & Last Name & Degree
Jamie L. Dargart
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
405-271-8777
Email
ou-clinical-trials@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Rene Y. McNall-Knapp
Facility Name
Legacy Emanuel Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
503-413-2560
First Name & Middle Initial & Last Name & Degree
Janice F. Olson
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
503-494-1080
Email
trials@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Katrina Winsnes
Facility Name
Lehigh Valley Hospital-Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
610-402-9543
Email
Morgan_M.Horton@lvhn.org
First Name & Middle Initial & Last Name & Degree
Jacob A. Troutman
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
570-271-5251
Email
HemonCCTrials@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Jagadeesh Ramdas
Facility Name
Penn State Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
717-531-6012
First Name & Middle Initial & Last Name & Degree
Lisa M. McGregor
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
267-425-5544
Email
CancerTrials@email.chop.edu
First Name & Middle Initial & Last Name & Degree
Frank M. Balis
Facility Name
Saint Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
215-427-8991
First Name & Middle Initial & Last Name & Degree
Gregory E. Halligan
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-692-8570
Email
jean.tersak@chp.edu
First Name & Middle Initial & Last Name & Degree
Jean M. Tersak
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
401-444-1488
First Name & Middle Initial & Last Name & Degree
Jennifer J. Welch
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
843-792-9321
Email
hcc-clinical-trials@musc.edu
First Name & Middle Initial & Last Name & Degree
Jacqueline M. Kraveka
Facility Name
Prisma Health Richland Hospital
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-241-6251
First Name & Middle Initial & Last Name & Degree
Stuart L. Cramer
Facility Name
BI-LO Charities Children's Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-241-6251
First Name & Middle Initial & Last Name & Degree
Aniket Saha
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
605-312-3320
Email
OncologyClinicalTrialsSF@SanfordHealth.org
First Name & Middle Initial & Last Name & Degree
Kayelyn J. Wagner
Facility Name
T C Thompson Children's Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
423-778-7289
First Name & Middle Initial & Last Name & Degree
Benjamin A. Mixon
Facility Name
East Tennessee Childrens Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
865-541-8266
First Name & Middle Initial & Last Name & Degree
Susan E. Spiller
Facility Name
Saint Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-226-4343
Email
referralinfo@stjude.org
First Name & Middle Initial & Last Name & Degree
Michael W. Bishop
Facility Name
The Children's Hospital at TriStar Centennial
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
615-342-1919
First Name & Middle Initial & Last Name & Degree
Jennifer A. Domm
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-811-8480
First Name & Middle Initial & Last Name & Degree
Daniel J. Benedetti
Facility Name
Texas Tech University Health Sciences Center-Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
806-354-5411
First Name & Middle Initial & Last Name & Degree
Smita Bhaskaran
Facility Name
Dell Children's Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
512-628-1902
Email
TXAUS-DL-SFCHemonc.research@ascension.org
First Name & Middle Initial & Last Name & Degree
Shannon M. Cohn
Facility Name
Driscoll Children's Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
361-694-5311
Email
Crystal.DeLosSantos@dchstx.org
First Name & Middle Initial & Last Name & Degree
Nkechi I. Mba
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
972-566-5588
First Name & Middle Initial & Last Name & Degree
Stanton C. Goldman
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
214-648-7097
Email
canceranswerline@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Jonathan E. Wickiser
Facility Name
El Paso Children's Hospital
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
915-298-5444
Email
ranjan.bista@ttuhsc.edu
First Name & Middle Initial & Last Name & Degree
Ranjan Bista
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
682-885-2103
Email
CookChildrensResearch@cookchildrens.org
First Name & Middle Initial & Last Name & Degree
Kelly L. Vallance
Facility Name
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
713-798-1354
Email
burton@bcm.edu
First Name & Middle Initial & Last Name & Degree
Sarah B. Whittle
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Najat C. Daw
Facility Name
Covenant Children's Hospital
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
helpdesk@childrensoncologygroup.org
First Name & Middle Initial & Last Name & Degree
Kishor M. Bhende
Facility Name
UMC Cancer Center / UMC Health System
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
806-775-8590
First Name & Middle Initial & Last Name & Degree
Erin K. Barr
Facility Name
Children's Hospital of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
210-704-2894
Email
bridget.medina@christushealth.org
First Name & Middle Initial & Last Name & Degree
Timothy C. Griffin
Facility Name
Methodist Children's Hospital of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
210-575-6240
Email
Vinod.GidvaniDiaz@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Jose M. Esquilin
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
210-450-3800
Email
phoresearchoffice@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Anne-Marie R. Langevin
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
801-585-5270
First Name & Middle Initial & Last Name & Degree
Matthew Dietz
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
434-243-6303
Email
uvacancertrials@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
William C. Petersen
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
703-208-6650
Email
Stephanie.VanBebber@inova.org
First Name & Middle Initial & Last Name & Degree
Robin Y. Dulman
Facility Name
Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
757-668-7243
Email
CCBDCresearch@chkd.org
First Name & Middle Initial & Last Name & Degree
Eric J. Lowe
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
CTOclinops@vcu.edu
First Name & Middle Initial & Last Name & Degree
Frances Austin
Facility Name
Carilion Children's
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
540-266-6238
Email
wpmccarty@carilionclinic.org
First Name & Middle Initial & Last Name & Degree
Erwood G. Edwards
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
866-987-2000
First Name & Middle Initial & Last Name & Degree
Sarah E. Leary
Facility Name
Providence Sacred Heart Medical Center and Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-228-6618
Email
HopeBeginsHere@providence.org
First Name & Middle Initial & Last Name & Degree
Judy L. Felgenhauer
Facility Name
Mary Bridge Children's Hospital and Health Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
253-403-1461
Email
research@multicare.org
First Name & Middle Initial & Last Name & Degree
Robert G. Irwin
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
253-968-6144
Email
Melissa.a.forouhar.mil@mail.mil
First Name & Middle Initial & Last Name & Degree
Melissa A. Forouhar
Facility Name
West Virginia University Charleston Division
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
304-388-9944
First Name & Middle Initial & Last Name & Degree
Mohamad H. Badawi
Facility Name
Edwards Comprehensive Cancer Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
304-399-6566
Email
Christina.Cole@chhi.org
First Name & Middle Initial & Last Name & Degree
Mark A. Ranalli
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-622-8922
First Name & Middle Initial & Last Name & Degree
Kenneth B. De Santes
Facility Name
Marshfield Medical Center-Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Jon M. Brandt
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
414-955-4727
Email
MACCCTO@mcw.edu
First Name & Middle Initial & Last Name & Degree
Kerri Becktell
Facility Name
John Hunter Children's Hospital
City
Hunter Regional Mail Centre
State/Province
New South Wales
ZIP/Postal Code
2310
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
(02) 4985 5180
First Name & Middle Initial & Last Name & Degree
Elizabeth L. Hesketh
Facility Name
Sydney Children's Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
(02) 9382-1721
First Name & Middle Initial & Last Name & Degree
Draga Barbaric
Facility Name
The Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
61-2-9845 1400
First Name & Middle Initial & Last Name & Degree
Bhavna Padhye
Facility Name
Queensland Children's Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
61 7 3068 1111
First Name & Middle Initial & Last Name & Degree
Steven A. Foresto
Facility Name
Women's and Children's Hospital-Adelaide
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
(08) 8161 7327
Email
cywhs.oncsec@health.sa.gov.au
First Name & Middle Initial & Last Name & Degree
Maria L. Kirby
Facility Name
Monash Medical Center-Clayton Campus
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Suspended
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
61 3 9345 5656
Email
Jordan.Hansford@rch.org.au
First Name & Middle Initial & Last Name & Degree
Martin A. Campbell
Facility Name
Perth Children's Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
helpdesk@childrensoncologygroup.org
First Name & Middle Initial & Last Name & Degree
Marianne B. Phillips
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
403-220-6898
Email
research4kids@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Victor A. Lewis
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
780-407-8798
Email
pedsoncologyresearch@ahs.ca
First Name & Middle Initial & Last Name & Degree
Sarah J. McKillop
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
604-875-2345
Ext
6477
First Name & Middle Initial & Last Name & Degree
David B. Dix
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
866-561-1026
Email
ctu_web@cancercare.mb.ca
First Name & Middle Initial & Last Name & Degree
Issai M. Vanan
Facility Name
Janeway Child Health Centre
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
866-722-1126
First Name & Middle Initial & Last Name & Degree
Lisa A. Goodyear
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
902-470-8520
Email
Research@iwk.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Craig Erker
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
905-521-2100
First Name & Middle Initial & Last Name & Degree
Uma H. Athale
Facility Name
Children's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
519-685-8306
First Name & Middle Initial & Last Name & Degree
Shayna M. Zelcer
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
613-737-7600
First Name & Middle Initial & Last Name & Degree
Donna L. Johnston
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
416-813-7654
Email
ask.CRS@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Daniel A. Morgenstern
Facility Name
The Montreal Children's Hospital of the MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
514-412-4445
Email
info@thechildren.com
First Name & Middle Initial & Last Name & Degree
Sharon B. Abish
Facility Name
Centre Hospitalier Universitaire Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
514-345-4931
Email
yvan.samson@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Monia Marzouki
Facility Name
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
819-820-6480
Email
crcinformation.chus@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Josee Brossard
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
418-525-4444
First Name & Middle Initial & Last Name & Degree
Bruno Michon
Facility Name
Starship Children's Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1145
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
0800 728 436
First Name & Middle Initial & Last Name & Degree
Mandy PohLui de Silva
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
03 364 0640
First Name & Middle Initial & Last Name & Degree
Amanda J. Lyver
Facility Name
HIMA San Pablo Oncologic Hospital
City
Caguas
ZIP/Postal Code
00726
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
787-653-3434
First Name & Middle Initial & Last Name & Degree
Jhon A. Guerra
Facility Name
University Pediatric Hospital
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
787-474-0333
First Name & Middle Initial & Last Name & Degree
Maria E. Echevarria
Facility Name
King Faisal Specialist Hospital and Research Centre
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
011-966-1-464-7272
Ext
38005
First Name & Middle Initial & Last Name & Degree
Afshan A. Ali

12. IPD Sharing Statement

Learn more about this trial

A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT

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