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A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT

Primary Purpose

Central Nervous System Nongerminomatous Germ Cell Tumor, Choriocarcinoma, Embryonal Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Carboplatin
Etoposide
Filgrastim
Ifosfamide
Mesna
Pegfilgrastim
Peripheral Blood Stem Cell Transplantation
Questionnaire Administration
Radiation Therapy
Radiation Therapy
Second-Look Surgery
Thiotepa
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Nervous System Nongerminomatous Germ Cell Tumor

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must be >= 3 years and < 30 years at the time of study enrollment
  • Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or > 10 ng/mL or human chorionic gonadotropin (hCG) beta > 100 mIU/mL. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 21 days prior to enrollment and within 35 days prior to start of protocol therapy [repeat if necessary]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy [repeat if necessary]). Basal ganglia or other primary sites are excluded
  • Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present. Patients with only mature teratoma are excluded. Patients with pure germinoma admixed with mature teratoma are excluded (would be eligible for pure germinoma protocols)
  • Patients must have a cranial magnetic resonance imaging (MRI) with and without gadolinium at diagnosis/prior to enrollment. If surgical resection is performed, patients must have pre-operative and post operative brain MRI with and without gadolinium. The post operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required (within 14 days prior to study enrollment)
  • Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment. Spine MRI with and without gadolinium is recommended (within 14 days prior to study enrollment)
  • Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery
  • Patients must have CSF tumor markers obtained prior to enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy/surgery are combined, CSF tumor markers should be collected first
  • Peripheral absolute neutrophil count (ANC) >= 1000/uL (within 7 days prior to enrollment)
  • Platelet count >= 100,000/uL (transfusion independent) (within 7 days prior to enrollment)
  • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (within 7 days prior to enrollment)

  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment):

    • Age: Maximum serum creatinine (mg/dL)

      • 3 to < 6 years: 0.8 (male), 0.8 (female)
      • 6 to < 10 years: 1 (male), 1 (female)
      • 10 to < 13 years: 1.2 (male), 1.2 (female)
      • 13 to < 16 years: 1.5 (male), 1.4 (female)
      • >= 16 years: male (1.7), 1.4 (female)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)

  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (within 7 days prior to enrollment)

    • Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L

  • Central nervous system function defined as:

    • Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
    • Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment
  • Protocol therapy must begin within 31 calendar days of definitive surgery or clinical diagnosis. If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery.
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
  • NEUROCOGNITIVE FUNCTION AND QUALITY OF LIFE ASSESSMENT:

  • English-, Spanish-, or French- speaking

    • Note: Patients who speak a language other than English, Spanish, or French will be allowed to participate in ACNS2021 but will not complete the neurocognitive and quality of life assessments
  • No known history of neurodevelopmental disorder prior to diagnosis of NGGCT (e.g., Down syndrome, fragile X, William syndrome, intellectual disability). Patients with NF1 will be allowed to participate

  • Additional eligibility criteria for the COG Standardized Neuropsychological Battery only: must be at a site that has a psychologist to administer the battery

    • Note: If not eligible for the COG Standardized Battery, patients should still complete the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), Pediatric Quality of Life Inventory (PedsQL), Adaptive Behavior Assessment System Third Edition (ABAS-3), and Behavior Assessment System for Children, Third Edition (BASC-3) questionnaires

Exclusion Criteria:

  • Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus)
  • Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis
  • Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids
  • Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination)

  • Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs

    • Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards
  • 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
  • Providence Alaska Medical CenterRecruiting
  • Banner Children's at DesertRecruiting
  • Phoenix Childrens HospitalRecruiting
  • Banner University Medical Center - TucsonRecruiting
  • University of Arizona Cancer Center-North CampusRecruiting
  • Arkansas Children's HospitalRecruiting
  • Kaiser Permanente Downey Medical CenterRecruiting
  • Loma Linda University Medical CenterRecruiting
  • Children's Hospital Los AngelesRecruiting
  • Kaiser Permanente Los Angeles Medical CenterRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • Valley Children's HospitalRecruiting
  • Kaiser Permanente-OaklandRecruiting
  • Children's Hospital of Orange CountyRecruiting
  • Rady Children's Hospital - San DiegoRecruiting
  • UCSF Medical Center-Mission BayRecruiting
  • Children's Hospital ColoradoRecruiting
  • Connecticut Children's Medical CenterRecruiting
  • Alfred I duPont Hospital for ChildrenRecruiting
  • Children's National Medical CenterRecruiting
  • Golisano Children's Hospital of Southwest FloridaRecruiting
  • University of Florida Health Science Center - GainesvilleRecruiting
  • Nemours Children's Clinic-JacksonvilleRecruiting
  • Nicklaus Children's HospitalRecruiting
  • Arnold Palmer Hospital for ChildrenRecruiting
  • Nemours Children's HospitalRecruiting
  • Johns Hopkins All Children's HospitalRecruiting
  • Saint Joseph's Hospital/Children's Hospital-TampaRecruiting
  • Children's Healthcare of Atlanta - EglestonRecruiting
  • Kapiolani Medical Center for Women and ChildrenRecruiting
  • Saint Luke's Cancer Institute - BoiseRecruiting
  • University of IllinoisRecruiting
  • Loyola University Medical CenterRecruiting
  • Saint Jude Midwest AffiliateRecruiting
  • Riley Hospital for ChildrenRecruiting
  • Blank Children's HospitalRecruiting
  • University of Iowa/Holden Comprehensive Cancer CenterRecruiting
  • Norton Children's HospitalRecruiting
  • Ochsner Medical Center JeffersonRecruiting
  • Eastern Maine Medical Center
  • Maine Children's Cancer ProgramRecruiting
  • Sinai Hospital of BaltimoreRecruiting
  • Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
  • Massachusetts General Hospital Cancer CenterRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • C S Mott Children's HospitalRecruiting
  • Children's Hospital of MichiganRecruiting
  • Michigan State University Clinical CenterRecruiting
  • Helen DeVos Children's Hospital at Spectrum HealthRecruiting
  • Spectrum Health at Butterworth CampusRecruiting
  • Beaumont Children's Hospital-Royal OakRecruiting
  • Children's Hospitals and Clinics of Minnesota - MinneapolisRecruiting
  • 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
  • GenesisCare USA - Las VegasRecruiting
  • Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
  • Renown Regional Medical CenterRecruiting
  • Cancer Care Specialists - Reno
  • Hackensack University Medical CenterRecruiting
  • Morristown Medical CenterRecruiting
  • Saint Peter's University HospitalRecruiting
  • 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
  • Maimonides Medical CenterRecruiting
  • The Steven and Alexandra Cohen Children's Medical Center of New YorkRecruiting
  • Laura and Isaac Perlmutter Cancer Center at NYU LangoneRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Stony Brook University Medical CenterRecruiting
  • State University of New York Upstate Medical UniversityRecruiting
  • New York Medical CollegeRecruiting
  • Carolinas Medical Center/Levine Cancer InstituteRecruiting
  • 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 Flower 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
  • Penn State Children's HospitalRecruiting
  • 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
  • Prisma Health Cancer Institute - FarisRecruiting
  • Sanford USD Medical Center - Sioux FallsRecruiting
  • Saint Jude Children's Research HospitalRecruiting
  • The Children's Hospital at TriStar CentennialRecruiting
  • Vanderbilt University/Ingram Cancer CenterRecruiting
  • Dell Children's Medical Center of Central Texas
  • 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
  • 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
  • Children's Hospital of The King's DaughtersRecruiting
  • Virginia Commonwealth University/Massey Cancer CenterRecruiting
  • Carilion Children'sRecruiting
  • Seattle Children's HospitalRecruiting
  • Mary Bridge Children's Hospital and Health CenterRecruiting
  • Madigan Army Medical CenterRecruiting
  • West Virginia University HealthcareRecruiting
  • University of Wisconsin Carbone Cancer CenterRecruiting
  • Marshfield Medical Center-MarshfieldRecruiting
  • The Children's Hospital at WestmeadRecruiting
  • Queensland Children's HospitalRecruiting
  • Royal Children's HospitalRecruiting
  • Perth Children's HospitalRecruiting
  • Alberta Children's HospitalRecruiting
  • University of Alberta HospitalRecruiting
  • The Montreal Children's Hospital of the MUHC
  • Centre Hospitalier Universitaire Sainte-JustineRecruiting
  • Centre Hospitalier Universitaire de QuebecRecruiting
  • Christchurch HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Plan A (chemotherapy, WVSCI, second-look surgery if needed)

Plan B (chemotherapy, HDCSCR, second-look surgery if needed)

Arm Description

See Outline in Detailed Description.

See Outline in Detailed Description.

Outcomes

Primary Outcome Measures

Failure rate
Will be measured by the number of progressions or deaths within 2 years of enrollment for the cohort treated with whole ventricular + spinal canal irradiation (WVSCI). The final analysis will include an exact binomial confidence interval of the failure rate for each of the failure types (local, distant/spinal or both) without adjustment for multiplicity.
Spinal failure rate
Will be measured by the number of spinal relapses (spine alone or distant relapses including the spine) within 2 years of enrollment in patients treated with WVSCI. The final analysis will include an exact binomial confidence interval of spinal failure rate.

Secondary Outcome Measures

Radiographic complete response (CR)/partial response (PR) with marker normalization rate post induction/second-look surgery
Will be assessed in patients treated with induction chemotherapy. Will be estimated using an exact binomial approach and its confidence interval.
Radiographic complete response (CR)/partial response (PR) with marker normalization rate post high-dose chemotherapy with peripheral stem cell rescue (HDCSCR)
Will be assessed in patients treated with HDCSCR. Will be estimated using an exact binomial approach and its confidence interval.
Progression-free survival (PFS)
Will be estimated separately for those treated with WVSCI and with HDCSCR + radiation therapy. Kaplan-Maier based PFS curve estimates will be included, where patients who are lost to follow up will be treated as censored observations as part of the primary analyses.
Overall survival (OS)
Will be estimated separately for those treated with WVSCI and with HDCSCR + radiation therapy. Kaplan-Maier based OS curve estimates will be included, where patients who are lost to follow up will be treated as censored observations as part of the secondary analyses.
Patterns of disease recurrence/failure
Will be analyzed in an exploratory manner with respect to radiation dose distribution.

Full Information

First Posted
December 15, 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
NCT04684368
Brief Title
A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Official Title
A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular &Amp; Spinal Canal Irradiation (WVSCI) for Patients With Localized Non-Germinomatous Central Nervous System Germ Cell Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 4, 2021 (Actual)
Primary Completion Date
December 21, 2029 (Anticipated)
Study Completion Date
December 21, 2029 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, 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. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.
Detailed Description
PRIMARY OBJECTIVES: I. To monitor outcome to ensure that children and young adults with localized central nervous system (CNS) non-germinomatous germ cell tumors (NGGCT) treated with induction chemotherapy followed by response evaluation and whole ventricular + spinal canal irradiation (WVSCI) will maintain the excellent 2-year progression free survival (PFS) rate as compared to ACNS0122 (NCT00047320). II. To improve disease control by decreasing the number of spinal relapses for patients who achieve a complete response (CR) or partial response (PR) and receive WVSCI as compared to whole ventricular radiation on ACNS1123 (NCT01602666). SECONDARY OBJECTIVES: I. To estimate the response rates to induction chemotherapy and WVSCI for localized NGGCT patients who achieve a CR/PR. II. To estimate the PFS and overall survival (OS) for localized NGGCT patients who achieve a CR/PR and receive WVSCI. III. To estimate the PFS and OS for patients with less than a CR/PR following Induction who subsequently receive high-dose chemotherapy with peripheral stem cell rescue (HDCSCR). IV. To estimate the response rate for patients with less than a CR/PR following Induction who subsequently receive HDCSCR. EXPLORATORY OBJECTIVES: I. To prospectively compare outcomes based on radiation modality, photon versus proton, including cognitive, social and behavioral functioning, auditory, and neuro-endocrine function. II. To compare spinal column growth and cell counts following radiation as measured by height and weight, and complete blood count (CBC) values during and after radiation therapy, based on treatment modality (photon versus [vs.] proton therapy) and planned inclusion/exclusion of the vertebral body in patients < 13 years of age. III. To compare local vs. central review recommendations for second-look surgery and document barriers for performing such surgeries as well as their clinical benefit in pediatric NGGCT. IV. To prospectively evaluate and longitudinally model the cognitive, social, and behavioral functioning of children and young adults with localized CNS NGGCT with testing as per the Children's Oncology Group (COG) Standardized Neuropsychological and Behavioral Battery. V. To evaluate patterns of disease recurrence/failure with respect to radiation dose distribution. OUTLINE: INDUCTION CHEMOTHERAPY: Patients receive carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of cycles 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide IV over 60-120 minutes on days 1-5 of cycles 2, 4, and 6. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients are assigned to 1 of 2 plans (ventricular + spinal canal irradiation [WVSCI] or high-dose chemotherapy with peripheral stem cell rescue [HDCSCR]) based on response to induction chemotherapy: Patients who achieve radiographic CR/PR with marker normalization proceed to WVSCI. Patients who achieve radiographic CR without marker normalization proceed to HDCSCR. Patients who achieve less than radiographic CR/PR with marker normalization proceed to second-look surgery (unless contraindicated). If second-look surgery reveals mature teratoma or non-viable tumor, proceed to WVSCI. If second-look surgery reveals viable tumor, proceed to HDCSCR. Patients who are unable to undergo second-look surgery are removed from protocol therapy but remain on study for follow-up. Patients who achieve less than radiographic CR/PR without marker normalization proceed to second-look surgery (unless contraindicated). Patients then proceed to HDCSCR regardless of whether or not a second-look surgery is performed. Patients who achieve radiographic PR without marker normalization proceed to second-look surgery (unless contraindicated). Patients then proceed to HDCSCR regardless of whether or not a second-look surgery is performed. PLAN A (WVSCI THERAPY): Within 6 weeks of the end of induction chemotherapy or second-look surgery, patients undergo WVSCI once daily (QD) for 5 days weekly (17 fractions followed by a boost dose for 13 fractions) for 6 weeks in the absence of disease progression or unacceptable toxicity. PLAN B (CONSOLIDATION THERAPY [HDCSCR]): Within 6-8 weeks of the end of induction chemotherapy or second-look surgery, patients receive etoposide IV and thiotepa IV over 3 hours on days -5 to -3 and undergo peripheral blood stem cell (PBSC) transplant on day 0. Patients then undergo radiation therapy QD for 5 days weekly (20 fractions followed by a boost dose for 10 fractions) for 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for up to 10 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Nongerminomatous Germ Cell Tumor, Choriocarcinoma, Embryonal Carcinoma, Immature Teratoma, Malignant Teratoma, Mixed Germ Cell Tumor, Pineal Region Germ Cell Tumor, Pineal Region Immature Teratoma, Pineal Region Yolk Sac Tumor, Suprasellar Germ Cell Tumor

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Plan A (chemotherapy, WVSCI, second-look surgery if needed)
Arm Type
Experimental
Arm Description
See Outline in Detailed Description.
Arm Title
Plan B (chemotherapy, HDCSCR, second-look surgery if needed)
Arm Type
Experimental
Arm Description
See Outline in Detailed Description.
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
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
Biological
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
Filgrastim-aafi, G-CSF, Neupogen, Nivestym, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, rG-CSF, Tevagrastim
Intervention Description
Given subcutaneously (SC) or 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)
Mesna
Other Intervention Name(s)
2-Mercaptoethanesulfonate, Sodium Salt, Ausobronc, D-7093, Filesna, Mercaptoethane Sulfonate, Mercaptoethanesulfonate, Mesnex, Mesnil, Mesnum, Mexan, Mistabron, Mistabronco, Mitexan, Mucofluid, Mucolene, UCB 3983, Uromitexan, Ziken
Intervention Description
Given IV or orally
Intervention Type
Biological
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Filgrastim SD-01, filgrastim-SD/01, Fulphila, HSP-130, Jinyouli, Neulasta, Neulastim, Nyvepria, PEG-filgrastim, Pegcyte, Pegfilgrastim Biosimilar HSP-130, Pegfilgrastim Biosimilar Nyvepria, Pegfilgrastim Biosimilar Pegcyte, Pegfilgrastim Biosimilar PF-06881894, Pegfilgrastim Biosimilar Udenyca, Pegfilgrastim Biosimilar Ziextenzo, pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, Pegfilgrastim-jmdb, PF-06881894, SD-01, SD-01 sustained duration G-CSF, Udenyca, Ziextenzo
Intervention Description
Given SC
Intervention Type
Procedure
Intervention Name(s)
Peripheral Blood Stem Cell Transplantation
Other Intervention Name(s)
PBPC transplantation, PBSCT, Peripheral Blood, Peripheral Blood Progenitor Cell Transplantation, PERIPHERAL BLOOD STEM CELL TRANSPLANT, Peripheral Stem Cell Support, Peripheral Stem Cell Transplant, Peripheral Stem Cell Transplantation
Intervention Description
Undergo PBSC transplant
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo WVSCI radiation therapy
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo radiation therapy
Intervention Type
Procedure
Intervention Name(s)
Second-Look Surgery
Other Intervention Name(s)
Reoperation, Repeat Surgery, Second Look, Surgical Revision
Intervention Description
Undergo second-look surgery if needed
Intervention Type
Drug
Intervention Name(s)
Thiotepa
Other Intervention Name(s)
1,1',1''-Phosphinothioylidynetrisaziridine, Girostan, N,N', N''-Triethylenethiophosphoramide, Oncotiotepa, STEPA, Tepadina, TESPA, Tespamin, Tespamine, Thio-Tepa, Thiofosfamide, Thiofozil, Thiophosphamide, Thiophosphoramide, Thiotef, Tifosyl, TIO TEF, Tio-tef, Triethylene Thiophosphoramide, Triethylenethiophosphoramide, Tris(1-aziridinyl)phosphine sulfide, TSPA, WR 45312
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Failure rate
Description
Will be measured by the number of progressions or deaths within 2 years of enrollment for the cohort treated with whole ventricular + spinal canal irradiation (WVSCI). The final analysis will include an exact binomial confidence interval of the failure rate for each of the failure types (local, distant/spinal or both) without adjustment for multiplicity.
Time Frame
Within 2 years of enrollment
Title
Spinal failure rate
Description
Will be measured by the number of spinal relapses (spine alone or distant relapses including the spine) within 2 years of enrollment in patients treated with WVSCI. The final analysis will include an exact binomial confidence interval of spinal failure rate.
Time Frame
Within 2 years of enrollment
Secondary Outcome Measure Information:
Title
Radiographic complete response (CR)/partial response (PR) with marker normalization rate post induction/second-look surgery
Description
Will be assessed in patients treated with induction chemotherapy. Will be estimated using an exact binomial approach and its confidence interval.
Time Frame
Up to 60 months post-treatment initiation
Title
Radiographic complete response (CR)/partial response (PR) with marker normalization rate post high-dose chemotherapy with peripheral stem cell rescue (HDCSCR)
Description
Will be assessed in patients treated with HDCSCR. Will be estimated using an exact binomial approach and its confidence interval.
Time Frame
Up to 60 months post-treatment initiation
Title
Progression-free survival (PFS)
Description
Will be estimated separately for those treated with WVSCI and with HDCSCR + radiation therapy. Kaplan-Maier based PFS curve estimates will be included, where patients who are lost to follow up will be treated as censored observations as part of the primary analyses.
Time Frame
From enrollment until disease progression or death from any cause for patients with events, and until final follow up for those who are event free at the time of analysis, assessed up to 10 years
Title
Overall survival (OS)
Description
Will be estimated separately for those treated with WVSCI and with HDCSCR + radiation therapy. Kaplan-Maier based OS curve estimates will be included, where patients who are lost to follow up will be treated as censored observations as part of the secondary analyses.
Time Frame
From enrollment until death from any cause for patients with events and until final follow up for those who are alive at the time of analysis, assessed up to 10 years
Title
Patterns of disease recurrence/failure
Description
Will be analyzed in an exploratory manner with respect to radiation dose distribution.
Time Frame
Up to 10 years
Other Pre-specified Outcome Measures:
Title
Change in intelligence scores within each treatment arm
Description
Will be assessed by the Wechsler Preschool and Primary Scale of Intelligence 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children 5th Edition (WISC-V), and the Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV), depending on patient's age. One-sample confidence intervals will be used to estimate mean pairwise changes in intelligence scores between 2 time points within each treatment arm.
Time Frame
Baseline up to 60 months post-treatment initiation
Title
Change in intelligence scores between treatment arms
Description
Will be assessed by the Wechsler Preschool and Primary Scale of Intelligence 4th Edition (WPPSI- IV), Wechsler Intelligence Scale for Children 5th Edition (WISC V), and the Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV), depending on patient's age. A 2-sample confidence interval approach will be used to estimate the difference in score changes between the two cohorts (WVSCI versus HDCSCR) in order to describe differential effects of the 2 treatment strategies.
Time Frame
Baseline up to 60 months post-treatment initiation
Title
Change in processing speed/attention within each treatment arm
Description
Will be assessed by the WISC-V or WAIS-IV processing speed index tasks. One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within each treatment arm.
Time Frame
Baseline up to 60 months post-treatment initiation
Title
Change in processing speed/attention between the two treatment arms
Description
Will be assessed by the WISC-V or WAIS-IV processing speed index tasks. A 2-sample confidence interval approach will be used to estimate the difference in score changes between the two cohorts (WVSCI versus HDCSCR) in order to describe differential effects of the 2 treatment strategies.
Time Frame
Baseline up to 60 months post-treatment initiation
Title
Change in immediate visual memory within each arm
Description
Will be assessed by the Children's Memory Scale and California Verbal Learning Test. One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within treatment arms, as appropriate.
Time Frame
Baseline up to 60 months post-treatment initiation
Title
Change in social-emotional functioning within each arm
Description
Will be assessed by the Behavior Assessment System for Children - 3rd Edition. One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within treatment arms, as appropriate.
Time Frame
Baseline up to 60 months post-treatment initiation
Title
Change in adaptive functioning within each arm
Description
Will be assessed by the Adaptive Behavior Assessment System - 3rd Edition. One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within treatment arms, as appropriate.
Time Frame
Baseline up to 60 months post-treatment initiation
Title
Change in health-related quality of life within each arm
Description
Will be assessed by the Pediatric Quality of Life Inventory version 4.0. One-sample confidence intervals will be used to estimate mean pairwise changes in scores between 2 time points within treatment arms, as appropriate.
Time Frame
Baseline up to 60 months post-treatment initiation
Title
Change in health-related quality of life between the two treatment arms
Description
Will be assessed by the Pediatric Quality of Life Inventory version 4.0. 2-sample confidence interval approach will be used to estimate the difference in score changes between the two cohorts (WVSCI versus HDCSCR) in order to describe differential effects of the 2 treatment strategies.
Time Frame
Baseline up to 60 months post-treatment initiation
Title
Radiation modality (proton versus photon)
Description
Will summarize and compare functional outcomes, including cognitive, social and behavioral functioning, and auditory and neuro-endocrine function, in the context of the radiation therapy modality used. Two sample t-tests for specified timepoints within each of the two treatment cohorts (WVSCI versus HDCSCR) will be used for comparisons.
Time Frame
Up to 10 years
Title
Growth comparisons following radiation by radiation modality
Description
Will compare early and late outcomes for proton and photon therapy with and without vertebral body sparing. Height and weight of subjects who are < 13 years at the time of radiation therapy will be collected until subjects go off study or reach the age of 21, whichever is earlier. Percentile values standardizing height and weight based on appropriate growth curves will be used to compare cohorts treated with proton- versus photon-based radiation therapy.
Time Frame
Up to 10 years
Title
Complete blood count values following radiation by radiation modality
Description
Complete blood count values during radiation therapy will be used to compare these outcomes in the context of proton- versus photon-based radiation therapy.
Time Frame
Up to 1 year post treatment initiation
Title
Local versus central review recommendations for second-look surgery
Description
Will summarize the local versus central review recommendations for second-look surgery and document any discrepancies.
Time Frame
Up to 1 year post treatment initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be >= 3 years and < 30 years at the time of study enrollment Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or > 10 ng/mL or human chorionic gonadotropin (hCG) beta > 100 mIU/mL. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 21 days prior to enrollment and within 35 days prior to start of protocol therapy [repeat if necessary]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy [repeat if necessary]). Basal ganglia or other primary sites are excluded Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present. Patients with only mature teratoma are excluded. Patients with pure germinoma admixed with mature teratoma are excluded (would be eligible for pure germinoma protocols) Patients must have a cranial magnetic resonance imaging (MRI) with and without gadolinium at diagnosis/prior to enrollment. If surgical resection is performed, patients must have pre-operative and post operative brain MRI with and without gadolinium. The post operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required (within 14 days prior to study enrollment) Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment. Spine MRI with and without gadolinium is recommended (within 14 days prior to study enrollment) Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery Patients must have CSF tumor markers obtained prior to enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy/surgery are combined, CSF tumor markers should be collected first Peripheral absolute neutrophil count (ANC) >= 1000/uL (within 7 days prior to enrollment) Platelet count >= 100,000/uL (transfusion independent) (within 7 days prior to enrollment) Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (within 7 days prior to enrollment) Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment): Age: Maximum serum creatinine (mg/dL) 3 to < 6 years: 0.8 (male), 0.8 (female) 6 to < 10 years: 1 (male), 1 (female) 10 to < 13 years: 1.2 (male), 1.2 (female) 13 to < 16 years: 1.5 (male), 1.4 (female) >= 16 years: male (1.7), 1.4 (female) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (within 7 days prior to enrollment) Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L Central nervous system function defined as: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment Protocol therapy must begin within 31 calendar days of definitive surgery or clinical diagnosis. If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery. All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met NEUROCOGNITIVE FUNCTION AND QUALITY OF LIFE ASSESSMENT: English-, Spanish-, or French- speaking Note: Patients who speak a language other than English, Spanish, or French will be allowed to participate in ACNS2021 but will not complete the neurocognitive and quality of life assessments No known history of neurodevelopmental disorder prior to diagnosis of NGGCT (e.g., Down syndrome, fragile X, William syndrome, intellectual disability). Patients with NF1 will be allowed to participate Additional eligibility criteria for the COG Standardized Neuropsychological Battery only: must be at a site that has a psychologist to administer the battery Note: If not eligible for the COG Standardized Battery, patients should still complete the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), Pediatric Quality of Life Inventory (PedsQL), Adaptive Behavior Assessment System Third Edition (ABAS-3), and Behavior Assessment System for Children, Third Edition (BASC-3) questionnaires Exclusion Criteria: Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus) Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination) Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards 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
Shannon M MacDonald
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
Girish Dhall
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
Phoenix Childrens Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
602-546-0920
First Name & Middle Initial & Last Name & Degree
Lindsey M. Hoffman
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
Holly E. Pariury
Facility Name
University of Arizona Cancer Center-North Campus
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
Holly E. Pariury
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
Hung N. Tran
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
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
Tom B. Davidson
Facility Name
Kaiser Permanente Los Angeles Medical Center
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
800-398-3996
Email
clinical.trials@kp.org
First Name & Middle Initial & Last Name & Degree
Hung N. Tran
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
310-423-8965
First Name & Middle Initial & Last Name & Degree
Fataneh (Fae) Majlessipour
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
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
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
Alyssa T. Reddy
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
Kathleen M. Dorris
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
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
Scott M. Bradfield
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
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
Scott M. Bradfield
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
Ziad A. Khatib
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
Scott M. Bradfield
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
Stacie L. Stapleton
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
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
Jason R. Fangusaro
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
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
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
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
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
Sandeep Batra
Phone
317-944-8784
Email
batras@iu.edu
First Name & Middle Initial & Last Name & Degree
Sandeep Batra
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
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
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
Stanley Chaleff
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
Kenneth J. Cohen
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-726-5130
First Name & Middle Initial & Last Name & Degree
Shannon M. MacDonald
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
Kee Kiat Yeo
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
Andrea T. Franson
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
Stephanie A. Toll
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
Spectrum Health at Butterworth Campus
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
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
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
Jonathan D. Schwartz
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
Mohamed S. Abdelbaki
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
GenesisCare USA - Las Vegas
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
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
Cancer Care Specialists - Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Individual Site Status
Suspended
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
Derek R. Hanson
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
Saint Peter's University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
732-745-8600
Ext
6163
Email
kcovert@saintpetersuh.com
First Name & Middle Initial & Last Name & Degree
Nibal A. Zaghloul
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
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
718-765-2500
First Name & Middle Initial & Last Name & Degree
Mahmut Y. Celiker
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
Mark P. Atlas
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
CancerTrials@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Sharon L. Gardner
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
Sameer Farouk Sait
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
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
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
Trent R. Hummel
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 Flower Hospital
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
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
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
Linda C. Stork
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
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
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
James T. Felker
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
Prisma Health Cancer Institute - Faris
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
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
Aditi Bagchi
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
Adam J. Esbenshade
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
Suspended
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
Daniel C. Bowers
Phone
214-648-3896
Email
Daniel.Bowers@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Daniel C. Bowers
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
Sibo Zhao
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
Jack M. Su
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
Najat C. Daw
Phone
713-792-6315
Email
ndaw@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Najat C. Daw
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
Luke D. Maese
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
Zhihong J. Wang
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
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 Healthcare
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
304-293-7374
Email
cancertrialsinfo@hsc.wvu.edu
First Name & Middle Initial & Last Name & Degree
Ashley E. Meyer
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
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
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
Dong-Anh Khuong-Quang
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
The Montreal Children's Hospital of the MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Individual Site Status
Suspended
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 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
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
Andrew J. Dodgshun

12. IPD Sharing Statement

Learn more about this trial

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT

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