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Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma

Primary Purpose

Neuroblastoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
irinotecan hydrochloride
temozolomide
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring recurrent neuroblastoma

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed neuroblastoma AND/OR demonstration of tumor cells in the bone marrow with increased urinary catecholamines at initial diagnosis Patients with elevated catecholamines only are not eligible Meets 1 of the following criteria: Recurrent disease following aggressive, multidrug, frontline chemotherapy, defined as chemotherapy given with ≥ 2 agents, including an alkylating agent and a platinum-containing compound Resistant/refractory disease during aggressive, multidrug, frontline chemotherapy Must meet 1 of the following criteria for documentation of disease: Unidimensionally measurable tumor ≥ 20 mm by MRI (Magnetic Resonance Imaging), CT scan (Computed Tomography), or x-ray OR ≥ 10 mm by spiral CT scan within 4 weeks prior to study entry Patients with residual stable tumor upon completion of frontline therapy must undergo biopsy to document presence of a viable neuroblastoma If the measurable target lesion was previously radiated, a biopsy must be performed ≥ 4 weeks after radiation was completed AND the biopsy must demonstrate viable neuroblastoma MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical) with positive uptake at ≥ 1 site within 4 weeks prior to study entry Patients with residual stable MIBG-positive lesions upon completion of frontline therapy must undergo biopsy to document presence of viable neuroblastoma If the patient has only 1 MIBG-positive lesion, and that lesion was previously radiated, a biopsy must be performed ≥ 4 weeks after radiation was completed AND the biopsy must demonstrate viable neuroblastoma Bone marrow with tumor cells on routine morphology (not by neuron-specific enolase staining only) of bilateral aspirate and/or biopsy on 1 bone marrow sample within 2 weeks prior to study entry No extensive marrow disease No myelodysplastic syndrome PATIENT CHARACTERISTICS: Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age) Life expectancy ≥ 8 weeks Absolute neutrophil count ≥ 750/mm^3 Platelet count ≥ 75,000/mm^3 (transfusion independent) Hemoglobin ≥ 8.5 mg/dL (transfusion allowed) Creatinine adjusted according to age as follows: No greater than 0.4 mg/dL (≤ 5 months) No greater than 0.5 mg/dL (6 months -11 months) No greater than 0.6 mg/dL (1 year-23 months) No greater than 0.8 mg/dL (2 years-5 years) No greater than 1.0 mg/dL (6 years-9 years) No greater than 1.2 mg/dL (10 years-12 years) No greater than 1.4 mg/dL (13 years and over [female]) No greater than 1.5 mg/dL (13 years to 15 years [male]) No greater than 1.7 mg/dL (16 years and over [male]) OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age ALT < 2.5 times ULN for age Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Seizure disorder allowed provided seizures are well controlled on non-EIAC medication No active diarrhea or uncontrolled infection No other malignancy, including secondary malignancy PRIOR CONCURRENT THERAPY: See Disease Characteristics Prior front-line therapy (e.g., surgery, chemotherapy, immunotherapy, radiotherapy, or retinoids) allowed Recovered from prior therapy More than 4 weeks since prior radiation therapy to the site of any lesion that will be identified as a target lesion to measure tumor response At least 2 weeks since prior myelosuppressive therapy (4 weeks for nitrosourea) At least 1 week since prior therapy with an antineoplastic biologic agent or retinoid At least 1 week since prior growth factors At least 1 week since prior and no other concurrent anticancer agents At least 1 week since prior and no concurrent enzyme-inducing anticonvulsants (EIAC), including phenytoin, phenobarbital, valproic acid, or carbamazepine Concurrent gabapentin or levetiracetam allowed Concurrent palliative radiation therapy to sites not used to measure tumor response allowed No prior allogeneic stem cell transplantation (SCT) Prior autologous SCT allowed No prior second-line chemotherapy for relapsed or refractory disease No concurrent immunomodulating agents Concurrent steroids for transfusion/infusion reactions or for treatment of edema associated with CNS lesions allowed

Sites / Locations

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
  • Arizona Cancer Center at University of Arizona Health Sciences Center
  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Southern California Permanente Medical Group
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
  • Childrens Hospital Los Angeles
  • Children's Hospital Central California
  • Children's Hospital and Research Center Oakland
  • Children's Hospital of Orange County
  • Sutter Cancer Center
  • Kaiser Permanente Medical Center - Oakland
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Stanford Cancer Center
  • Children's Hospital Center for Cancer and Blood Disorders
  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
  • Alfred I. duPont Hospital for Children
  • Children's National Medical Center
  • Lee Cancer Care of Lee Memorial Health System
  • University of Florida Shands Cancer Center
  • Nemours Children's Clinic
  • University of Miami Sylvester Comprehensive Cancer Center - Miami
  • Miami Children's Hospital
  • Florida Hospital Cancer Institute at Florida Hospital Orlando
  • Sacred Heart Cancer Center at Sacred Heart Hospital
  • All Children's Hospital
  • St. Joseph's Cancer Institute at St. Joseph's Hospital
  • Kaplan Cancer Center at St. Mary's Medical Center
  • Winship Cancer Institute of Emory University
  • Cancer Research Center of Hawaii
  • Mountain States Tumor Institute at St. Luke's Regional Medical Center
  • University of Illinois Cancer Center
  • Children's Memorial Hospital - Chicago
  • University of Chicago Cancer Research Center
  • Indiana University Melvin and Bren Simon Cancer Center
  • Blank Children's Hospital
  • Holden Comprehensive Cancer Center at University of Iowa
  • Lucille P. Markey Cancer Center at University of Kentucky
  • Kosair Children's Hospital
  • Children's Hospital of New Orleans
  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  • Floating Hospital for Children at Tufts - New England Medical Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • C.S. Mott Children's Hospital at University of Michigan Medical Center
  • Barbara Ann Karmanos Cancer Institute
  • Hurley Medical Center
  • Butterworth Hospital at Spectrum Health
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • CCOP - Kalamazoo
  • Breslin Cancer Center at Ingham Regional Medical Center
  • Children's Hospitals and Clinics of Minnesota - Minneapolis
  • Masonic Cancer Center at University of Minnesota
  • Mayo Clinic Cancer Center
  • University of Mississippi Cancer Clinic
  • Children's Mercy Hospital
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  • Children's Hospital
  • Sunrise Hospital and Medical Center
  • Hackensack University Medical Center Cancer Center
  • Overlook Hospital
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Newark Beth Israel Medical Center
  • University of New Mexico Cancer Center
  • Albert Einstein Cancer Center at Albert Einstein College of Medicine
  • Maimonides Cancer Center at Maimonides Medical Center
  • Roswell Park Cancer Institute
  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Stony Brook University Cancer Center
  • SUNY Upstate Medical University Hospital
  • New York Medical College
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Presbyterian Cancer Center at Presbyterian Hospital
  • Duke Comprehensive Cancer Center
  • Akron Children's Hospital
  • Cincinnati Children's Hospital Medical Center
  • Rainbow Babies and Children's Hospital
  • Cleveland Clinic Taussig Cancer Center
  • Nationwide Children's Hospital
  • Children's Medical Center - Dayton
  • Lehigh Valley Hospital - Muhlenberg
  • Geisinger Cancer Institute at Geisinger Health
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Children's Hospital of Philadelphia
  • St. Christopher's Hospital for Children
  • Children's Hospital of Pittsburgh
  • Hollings Cancer Center at Medical University of South Carolina
  • Palmetto Health South Carolina Cancer Center
  • East Tennessee Children's Hospital
  • Vanderbilt-Ingram Cancer Center
  • Dell Children's Medical Center of Central Texas
  • Driscoll Children's Hospital
  • Medical City Dallas Hospital
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Cook Children's Medical Center - Fort Worth
  • M. D. Anderson Cancer Center at University of Texas
  • Covenant Children's Hospital
  • University of Texas Health Science Center at San Antonio
  • Methodist Children's Hospital of South Texas
  • CCOP - Scott and White Hospital
  • Primary Children's Medical Center
  • Fletcher Allen Health Care - University Health Center Campus
  • Children's Hospital of The King's Daughters
  • Virginia Commonwealth University Massey Cancer Center
  • Children's Hospital and Regional Medical Center - Seattle
  • Providence Cancer Center at Sacred Heart Medical Center
  • West Virginia University Health Sciences Center - Charleston
  • St. Vincent Hospital Regional Cancer Center
  • Midwest Children's Cancer Center
  • John Hunter Hospital
  • Westmead Institute for Cancer Research at Westmead Hospital
  • Royal Children's Hospital
  • Royal Children's Hospital
  • Princess Margaret Hospital for Children
  • University of Alberta Hospital
  • Children's & Women's Hospital of British Columbia
  • CancerCare Manitoba
  • IWK Health Centre
  • McMaster Children's Hospital at Hamilton Health Sciences
  • Children's Hospital of Western Ontario
  • Children's Hospital of Eastern Ontario
  • Hospital for Sick Children
  • Montreal Children's Hospital at McGill University Health Center
  • Hopital Sainte Justine
  • Allan Blair Cancer Centre at Pasqua Hospital
  • Saskatoon Cancer Centre at the University of Saskatchewan
  • Centre Hospitalier Universitaire de Quebec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Disease measurable by CT or MRI scan (Irinotecan/Temozolomide)

Disease eval by bone marrow or MIBG (Irinotecan/Temozolomide)

Arm Description

Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
The patient's best overall response obtained during Reporting Periods 1 and 2 will be scored as "best response". Patients enrolled on Stratum 1 with bone marrow disease, a responder has no tumor cells detectable by routine morphology on 2 subsequent bilateral bone marrow aspirates and biopsies done at least 3 weeks apart. For patients enrolled on stratum 1 with MIBG only disease, response will be assessed using the Curie scale. Patients who have complete resolution of all MIBG positive lesions (CR) or resolution of at least one MIBG positive lesion with persistence of other lesions (PR) will be considered responders. For Stratum 2 a responder is defined to be a patient who achieves a best overall response of CR, VGPR or PR from CT/MRI scans from central review using (RECIST) Response Evaluation Criteria in Solid Tumor. A responder is defined to be a patient who achieves a best overall response of CR (Complete Response), VGPR (Very Good Partial Response) or PR (Partial Response).

Secondary Outcome Measures

Full Information

First Posted
April 5, 2006
Last Updated
September 16, 2014
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00311584
Brief Title
Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma
Official Title
A Phase II Study of Irinotecan + Temozolomide in Children With Recurrent Neuroblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with temozolomide works in treating young patients with recurrent neuroblastoma.
Detailed Description
OBJECTIVES: Primary Determine the response rate in pediatric patients with relapsed neuroblastoma (NB) treated with irinotecan hydrochloride and temozolomide. Determine the toxicities associated with irinotecan and temozolomide in patients treated with this regimen. Secondary Evaluate the impact of p53 loss of function on response rate and event-free survival from start of relapse therapy. Collect data for ongoing analyses of UGT1A1 polymorphisms in these patients. Collect and bank serum and nucleic acid specimen to facilitate future biomarker studies. Evaluate the feasibility of collecting blood samples on a group wide basis for assessment of changes in circulating markers of angiogenesis. Assess, preliminarily, the effects of irinotecan hydrochloride and temozolomide on circulating markers of angiogenesis. OUTLINE: This is a multicenter study. Patients are stratified according to disease status (measurable disease [measured by conventional CT scan and/or MRI] vs evaluable disease [tumor detected by conventional morphologic analysis of bone marrow aspirate/biopsy AND/OR abnormal uptake at ≥ 1 site on MIBG scan]). Patients receive irinotecan hydrochloride IV over 1 hour on days 1-5 and 8-12 and oral temozolomide on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 10 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
recurrent neuroblastoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Disease measurable by CT or MRI scan (Irinotecan/Temozolomide)
Arm Type
Experimental
Arm Description
Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm Title
Disease eval by bone marrow or MIBG (Irinotecan/Temozolomide)
Arm Type
Experimental
Arm Description
Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Other Intervention Name(s)
CPT-11, NSC #616348
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
temozolomide
Other Intervention Name(s)
TEMODAR, NSC #362856
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
Description
The patient's best overall response obtained during Reporting Periods 1 and 2 will be scored as "best response". Patients enrolled on Stratum 1 with bone marrow disease, a responder has no tumor cells detectable by routine morphology on 2 subsequent bilateral bone marrow aspirates and biopsies done at least 3 weeks apart. For patients enrolled on stratum 1 with MIBG only disease, response will be assessed using the Curie scale. Patients who have complete resolution of all MIBG positive lesions (CR) or resolution of at least one MIBG positive lesion with persistence of other lesions (PR) will be considered responders. For Stratum 2 a responder is defined to be a patient who achieves a best overall response of CR, VGPR or PR from CT/MRI scans from central review using (RECIST) Response Evaluation Criteria in Solid Tumor. A responder is defined to be a patient who achieves a best overall response of CR (Complete Response), VGPR (Very Good Partial Response) or PR (Partial Response).
Time Frame
up to 6 courses of therapy, or about 6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed neuroblastoma AND/OR demonstration of tumor cells in the bone marrow with increased urinary catecholamines at initial diagnosis Patients with elevated catecholamines only are not eligible Meets 1 of the following criteria: Recurrent disease following aggressive, multidrug, frontline chemotherapy, defined as chemotherapy given with ≥ 2 agents, including an alkylating agent and a platinum-containing compound Resistant/refractory disease during aggressive, multidrug, frontline chemotherapy Must meet 1 of the following criteria for documentation of disease: Unidimensionally measurable tumor ≥ 20 mm by MRI (Magnetic Resonance Imaging), CT scan (Computed Tomography), or x-ray OR ≥ 10 mm by spiral CT scan within 4 weeks prior to study entry Patients with residual stable tumor upon completion of frontline therapy must undergo biopsy to document presence of a viable neuroblastoma If the measurable target lesion was previously radiated, a biopsy must be performed ≥ 4 weeks after radiation was completed AND the biopsy must demonstrate viable neuroblastoma MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical) with positive uptake at ≥ 1 site within 4 weeks prior to study entry Patients with residual stable MIBG-positive lesions upon completion of frontline therapy must undergo biopsy to document presence of viable neuroblastoma If the patient has only 1 MIBG-positive lesion, and that lesion was previously radiated, a biopsy must be performed ≥ 4 weeks after radiation was completed AND the biopsy must demonstrate viable neuroblastoma Bone marrow with tumor cells on routine morphology (not by neuron-specific enolase staining only) of bilateral aspirate and/or biopsy on 1 bone marrow sample within 2 weeks prior to study entry No extensive marrow disease No myelodysplastic syndrome PATIENT CHARACTERISTICS: Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age) Life expectancy ≥ 8 weeks Absolute neutrophil count ≥ 750/mm^3 Platelet count ≥ 75,000/mm^3 (transfusion independent) Hemoglobin ≥ 8.5 mg/dL (transfusion allowed) Creatinine adjusted according to age as follows: No greater than 0.4 mg/dL (≤ 5 months) No greater than 0.5 mg/dL (6 months -11 months) No greater than 0.6 mg/dL (1 year-23 months) No greater than 0.8 mg/dL (2 years-5 years) No greater than 1.0 mg/dL (6 years-9 years) No greater than 1.2 mg/dL (10 years-12 years) No greater than 1.4 mg/dL (13 years and over [female]) No greater than 1.5 mg/dL (13 years to 15 years [male]) No greater than 1.7 mg/dL (16 years and over [male]) OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age ALT < 2.5 times ULN for age Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Seizure disorder allowed provided seizures are well controlled on non-EIAC medication No active diarrhea or uncontrolled infection No other malignancy, including secondary malignancy PRIOR CONCURRENT THERAPY: See Disease Characteristics Prior front-line therapy (e.g., surgery, chemotherapy, immunotherapy, radiotherapy, or retinoids) allowed Recovered from prior therapy More than 4 weeks since prior radiation therapy to the site of any lesion that will be identified as a target lesion to measure tumor response At least 2 weeks since prior myelosuppressive therapy (4 weeks for nitrosourea) At least 1 week since prior therapy with an antineoplastic biologic agent or retinoid At least 1 week since prior growth factors At least 1 week since prior and no other concurrent anticancer agents At least 1 week since prior and no concurrent enzyme-inducing anticonvulsants (EIAC), including phenytoin, phenobarbital, valproic acid, or carbamazepine Concurrent gabapentin or levetiracetam allowed Concurrent palliative radiation therapy to sites not used to measure tumor response allowed No prior allogeneic stem cell transplantation (SCT) Prior autologous SCT allowed No prior second-line chemotherapy for relapsed or refractory disease No concurrent immunomodulating agents Concurrent steroids for transfusion/infusion reactions or for treatment of edema associated with CNS lesions allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rochelle Bagatell, MD
Organizational Affiliation
University of Arizona
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cynthia S. Kretschmar, MD
Organizational Affiliation
Floating Hospital for Children at Tufts - New England Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Cancer Center at University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Downey
State/Province
California
ZIP/Postal Code
90242-2814
Country
United States
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital Central California
City
Madera
State/Province
California
ZIP/Postal Code
93638-8762
Country
United States
Facility Name
Children's Hospital and Research Center Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Kaiser Permanente Medical Center - Oakland
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5824
Country
United States
Facility Name
Children's Hospital Center for Cancer and Blood Disorders
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06360-2875
Country
United States
Facility Name
Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Lee Cancer Care of Lee Memorial Health System
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0232
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Florida Hospital Cancer Institute at Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803-1273
Country
United States
Facility Name
Sacred Heart Cancer Center at Sacred Heart Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
All Children's Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
St. Joseph's Cancer Institute at St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Kaplan Cancer Center at St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Mountain States Tumor Institute at St. Luke's Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712-6297
Country
United States
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7243
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Blank Children's Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1002
Country
United States
Facility Name
Lucille P. Markey Cancer Center at University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40232
Country
United States
Facility Name
Children's Hospital of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Floating Hospital for Children at Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
C.S. Mott Children's Hospital at University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0286
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Butterworth Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503-2560
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-5341
Country
United States
Facility Name
Breslin Cancer Center at Ingham Regional Medical Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Masonic Cancer Center at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Cancer Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Children's Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-4113
Country
United States
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109-2306
Country
United States
Facility Name
Hackensack University Medical Center Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Overlook Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
Facility Name
Albert Einstein Cancer Center at Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Maimonides Cancer Center at Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Stony Brook University Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-9446
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5000
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Children's Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404-1815
Country
United States
Facility Name
Lehigh Valley Hospital - Muhlenberg
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18107
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-9786
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134-1095
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Palmetto Health South Carolina Cancer Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
East Tennessee Children's Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Dell Children's Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Driscoll Children's Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Cook Children's Medical Center - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Covenant Children's Hospital
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Methodist Children's Hospital of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3993
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113-1100
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1971
Country
United States
Facility Name
Virginia Commonwealth University Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Providence Cancer Center at Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220-2555
Country
United States
Facility Name
West Virginia University Health Sciences Center - Charleston
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25302
Country
United States
Facility Name
St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3508
Country
United States
Facility Name
Midwest Children's Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
John Hunter Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2310
Country
Australia
Facility Name
Westmead Institute for Cancer Research at Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Children's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Children's & Women's Hospital of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Children's Hospital of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Montreal Children's Hospital at McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Allan Blair Cancer Centre at Pasqua Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre at the University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21115869
Citation
Bagatell R, London WB, Wagner LM, Voss SD, Stewart CF, Maris JM, Kretschmar C, Cohn SL. Phase II study of irinotecan and temozolomide in children with relapsed or refractory neuroblastoma: a Children's Oncology Group study. J Clin Oncol. 2011 Jan 10;29(2):208-13. doi: 10.1200/JCO.2010.31.7107. Epub 2010 Nov 29.
Results Reference
result

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Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma

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