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N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

Primary Purpose

Neuroblastoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Filgrastim
Carboplatin
Etoposide
Melphalan
Peripheral blood stem cell infusion
131I-MIBG
Radiation therapy
Sponsored by
Children's Hospital Los Angeles
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

1 Year - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of relapsed or refractory neuroblastoma Histologically confirmed and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites High-risk neuroblastoma must meet one of the following: Progressive disease prior to or after completion of induction therapy Mixed response or no response after completion of 4 courses of induction therapy Partial response after 4 courses of induction therapy allowed provided no prior participation in COG-A3973 or other phase III COG trials Measurable disease, defined as at least one metaiodobenzylguanidine (MIBG)-avid target lesion determined by diagnostic MIBG scan within 6 weeks of study entry (tumor sites that have received local irradiation within 3 months of study entry are not considered target lesions) PATIENT CHARACTERISTICS: Performance status Lansky 60-100% OR Karnofsky 60-100% Life expectancy At least 2 months Hematopoietic Hemoglobin ≥ 10 g/dL Absolute neutrophil count ≥ 750/mm^3 Platelet count ≥ 50,000/mm^3 (if no marrow involvement by morphologic exam/no transfusion allowed) (> 20,000/mm^3 if metastatic tumor involvement of marrow by morphologic exam/transfusion allowed) Hepatic Bilirubin < 1.3 mg/dL SGOT and SGPT < 5 times normal Hepatitis B surface antigen negative Hepatitis C negative Renal Glomerular filtration rate or creatinine clearance ≥ 60 ml/min Creatinine ≤ 1.5 times normal for age as follows: 0.8 mg/dL (for patients ≤ 5 years of age) 1.0 mg/dL (for patients 6 to 10 years of age) 1.2 mg/dL (for patients 11 to 15 years of age) 1.5 mg/dL (for patients > 15 years of age) Cardiovascular Ejection fraction ≥ 55% by echocardiogram or radionuclide MUGA OR Fractional shortening ≥ 27% by echocardiogram Pulmonary Normal lung function defined as no dyspnea at rest and no oxygen requirement OR measured oxygen saturation > 93% on room air Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No disease of any major organ system that would preclude study compliance No concurrent hemodialysis No active infection requiring IV antivirals, antibiotics, or antifungals (patients on antifungal therapy are eligible provided they are culture- and biopsy-negative in suspected residual radiographic lesions) Patient weight within limits to receive ≤ maximum total allowable dose of ^131I-MIBG PRIOR CONCURRENT THERAPY: Biologic therapy No prior myeloablative transplantation Prior submyeloablative transplantation allowed at discretion of principal investigator More than 3 weeks since prior biologic therapy Chemotherapy More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for mitomycin C or nitrosoureas) No prior melphalan therapy with a total dose of > 100 mg/m^2 Radiotherapy See Disease Characteristics At least 6 weeks since prior radiotherapy (6 months for craniospinal or whole lung radiotherapy) No prior total body irradiation No prior iodine I 131 MIBG (^131I-MIBG) No prior total abdominal or whole liver radiotherapy No prior local radiotherapy, including any of the following: 1200 cGy to more than 33% of both kidneys (patient must have at least one kidney that has not exceeded the dose/volume of radiation listed) 1800 cGy to more than 30% of liver and/or 900 cGy to more than 50% of liver Other Recovered from all prior therapy No medications with a potential interference of ^131I-MIBG uptake 1 week before and 2 weeks after completion of ^131I-MIBG

Sites / Locations

  • Childrens Hospital Los Angeles
  • Lucile Packard Children's Hospital at Stanford University Medical Center
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
  • University of Chicago Comer Children's Hospital
  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
  • C.S. Mott Children's Hospital at University of Michigan Medical Center
  • Morgan Stanley Children's Hospital of New York-Presbyterian
  • Cincinnati Children's Hospital Medical Center
  • Children's Hospital of Philadelphia
  • Cook Children's Medical Center - Fort Worth
  • Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
  • Children's Hospital and Regional Medical Center - Seattle
  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  • Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All the patients enrolled in the study

Arm Description

This is a single arm study. The following description applies to all the patients who are enrolled in the study: On Day -21, patients receive 131I-MIBG infusion. On Day -7, Day -6, Day -5, patients receive Carboplatin, Etoposide, Melphalan. On Day -4, patients receive Carboplatin, Etoposide. On Day -3, Day -2, Day -1, patients rest. On Day 0, patients receive peripheral blood stem cell infusion. Dosing of Carboplatin, Etoposide and Melphalan is based upon whole body dosimetry (cGy) estimates. Filgrastim 5 micrograms/kg/day S.C. or IV will be given daily beginning on Day 0. Local radiation therapy is to be given to previously non-irradiated primary and metastatic sites of disease.

Outcomes

Primary Outcome Measures

Response (Complete Response, Very Good Partial Response, and Partial Response) at 60-days Post Stem Cell Infusion
Tumor response based on evaluation performed on day 60 or at the time of disease progression/recurrence or start of another treatment - whichever comes first. Such evaluations will include 123I-MIBG scan, CT/MRI, urine catecholamine measurement, and bone marrow analysis (for those with marrow disease at study entry).

Secondary Outcome Measures

Event-free Survival (EFS) at 3 Years
EFS will be measured from start of treatment until progression, death or start of another treatment - whichever comes first. We report the estimated probability of EFS at 3 years.
Engraftment DLT
• Engraftment toxicity: delayed engraftment and/or failure to engraft defined as: neutrophils (ANC) < 500/μL by day 28 post transplant, or platelets < 20,000 /μL by day 56 post transplant, or if additional stem cells are required to be infused for any medical reason prior to initial engraftment of neutrophils or platelets.
Dose Limiting Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome SOS
Dose limiting veno-occlusive disease (VOD) defined as: the presence of hepatomegaly with right upper quadrant tenderness and an elevation of total bilirubin > grade 1, PLUS the presence of grade 3 abnormalities of any ONE of the following: total bilirubin, hypoalbuminemia, weight gain, or hypoxia without other attribution

Full Information

First Posted
November 11, 2005
Last Updated
April 6, 2023
Sponsor
Children's Hospital Los Angeles
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00253435
Brief Title
N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
Official Title
I-Metaiodobenzylguanidine (MIBG) With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as carboplatin, etoposide, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous peripheral stem cell or bone marrow transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Giving iodine I 131 metaiodobenzylguanidine and combination chemotherapy with an autologous peripheral stem cell or bone marrow transplant may allow more chemotherapy to be given so that more tumor cells are killed. Giving radiation therapy after an autologous peripheral stem cell or bone marrow transplant may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine together with combination chemotherapy and radiation therapy works in treating patients who are undergoing an autologous peripheral stem cell or bone marrow transplant for relapsed or refractory neuroblastoma.
Detailed Description
OBJECTIVES: Primary Determine the response rate in patients with relapsed or refractory neuroblastoma treated with iodine I 131 metaiodobenzylguanidine (^131I-MIBG) and combination chemotherapy comprising carboplatin, etoposide, and melphalan followed by autologous bone marrow or peripheral blood stem cell transplantation and radiotherapy. Secondary Determine the hematopoietic and nonhematopoietic toxicity of this regimen in these patients. Determine the tumor self-absorbed radiation dose (TSARD) in patients with measurable soft tissue lesions treated with this regimen. Correlate the TSARD with tumor response in patients with measurable residual soft tissue disease treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to risk (poor-risk group [mixed or no response to induction therapy or progression during or after induction therapy] vs good-risk group [partial response after 4 courses of induction therapy]) and kidney function at study entry (glomerular filtration rate [GFR] ≥ 100 mL/min vs GFR 60-99 mL/min) Stem cell harvest: Patients undergo a peripheral blood stem cell harvest or bone marrow harvest provided they have an adequate number of cells available. At least 2 weeks later, patients proceed to iodine I 131 metaiodobenzylguanidine (^131I-MIBG) and combination chemotherapy. 131I-MIBG and combination chemotherapy: Patients receive ^131I-MIBG IV over 2 hours on day -21, carboplatin IV continuously on days -7 to -4, etoposide IV continuously on days -7 to -4, and melphalan IV over 1 hour on days -7 to -5. Stem cell infusion and filgrastim (G-CSF): Three days after completion of chemotherapy, patients undergo transplantation of either stem cells or bone marrow on day 0. Patients also receive G-CSF subcutaneously or IV over 1 hour once daily beginning on day 0 and continuing until blood counts return to normal. Radiotherapy: Once blood counts return to normal, patients undergo radiotherapy to primary and metastatic sites that have not received previous irradiation over 12 days beginning after day 42. After completion of study treatment, patients are followed for 2 years and then periodically thereafter. PROJECTED ACCRUAL: Approximately 50 patients (40 low-risk patients and 8-10 high-risk 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All the patients enrolled in the study
Arm Type
Experimental
Arm Description
This is a single arm study. The following description applies to all the patients who are enrolled in the study: On Day -21, patients receive 131I-MIBG infusion. On Day -7, Day -6, Day -5, patients receive Carboplatin, Etoposide, Melphalan. On Day -4, patients receive Carboplatin, Etoposide. On Day -3, Day -2, Day -1, patients rest. On Day 0, patients receive peripheral blood stem cell infusion. Dosing of Carboplatin, Etoposide and Melphalan is based upon whole body dosimetry (cGy) estimates. Filgrastim 5 micrograms/kg/day S.C. or IV will be given daily beginning on Day 0. Local radiation therapy is to be given to previously non-irradiated primary and metastatic sites of disease.
Intervention Type
Biological
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
G-CSF
Intervention Description
Filgrastim 5 micrograms/kg/day S.C. or IV will be given daily beginning on Day 0. The first dose should begin four hours after the stem cell infusion is completed. Filgrastim will continue daily until the ANC >=1500/uL for three consecutive days.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
cis-diammine; Paraplatin; Paraplatin-AQ
Intervention Description
The carboplatin will be administered as a continuous IV infusion Day - 7 through Day - 4, with dosing based upon pretreatment GFR levels. The carboplatin should be diluted to a concentration of 0.3 mg/ml in D5W 0.45NS and infused concomitantly with etoposide through the same central venous catheter using a "Y" connector; a controlled rate infusion pump is used for each arm of the "Y".
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
VP-16; Etopophos
Intervention Description
The etoposide shall be administered day -7 through day -4 via continuous intravenous infusion over 96 hours. For patients with a corrected GFR >= 100 ml/min/1.72 m^2, a dose of 300 mg/m^2/day (10 mg/kg/day if child is < 12 kg) shall be given. For patients with a corrected GFR 60-99 ml/min/1.72 m^2, the etoposide will be administered at a dose of 160 mg/m^2/day (5.3 mg/kg/day). The etoposide will be diluted in D5W 0.45%NS at a concentration of < 0.4 mg/ml. Etoposide should not be mixed with carboplatin, but administered using a Y-connector.
Intervention Type
Drug
Intervention Name(s)
Melphalan
Other Intervention Name(s)
L-phenylalanine mustard; L-PAM; Alkeran; Sarcolysin
Intervention Description
For patients in either the normal GFR strata (>=100 ml/min/1.73 m^2), or reduced GFR strata (60-99 ml/min/1.73m^2), melphalan shall be administered at a dose of 60 mg/m^2/day (2 mg/kg/day if child is < 12 kg) on day -7, -6, and -5 of study. The melphalan should be infused at a rate of less than 10 mg/minute, and should complete within 1 hour of reconstitution each day. The melphalan should be diluted in 0.9% NaCl at a concentration < 2 mg/ml. The total dosage of melphalan to be administered will be 180 mg/m^2.
Intervention Type
Procedure
Intervention Name(s)
Peripheral blood stem cell infusion
Intervention Description
Stem cells or marrow will be infused on day 0 of study therapy. Where the DMSO concentration in the stem cell product would exceed accepted level for infusion within a 24 hour period, stem cell products may be infused over two days to meet this standard. For purged PBSC: A minimum of 2.0 x 10^6 viable CD34+ cells/kg must be available. For unpurged PBSC, a minimum of 2.0 x 10^6 viable CD34+ cells/kg must be available. Having a back-up of 2.0 x 10^6 viable CD34+ cells/kg purged or unpurged PBSC is recommended but not required. For purged bone marrow, a minimum of 1.5 x10^8 mononuclear cells/kg must be available.
Intervention Type
Radiation
Intervention Name(s)
131I-MIBG
Other Intervention Name(s)
Iobenguane I 131
Intervention Description
Therapeutic 131I MIBG will be synthesized by Draximage Canada.with specific activity between 15 and 25mCi/ml. Radiopurity will be initially determined by Draximage, prior to shipment to participating centers. Free radioiodide content must then be rechecked at the treating center prior to infusion using HPLC or Sep-Pac methodology.
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
Local irradiation is to be given to previously non-irradiated primary and metastatic sites of disease. Local irradiation should not start till the patient is medically stable, has an ANC > 1000/uL, platelets > 30,000 / uL, and is > 42 days post transplant. Recommended radiation guidelines consist of 2160 cGy total, given over 12 days using a single 180 cGy fraction/day. Any delay in local radiation that would extend treatment beyond day +84 should be discussed with the study chair. Local radiation will be administered at a participating NANT member site.
Primary Outcome Measure Information:
Title
Response (Complete Response, Very Good Partial Response, and Partial Response) at 60-days Post Stem Cell Infusion
Description
Tumor response based on evaluation performed on day 60 or at the time of disease progression/recurrence or start of another treatment - whichever comes first. Such evaluations will include 123I-MIBG scan, CT/MRI, urine catecholamine measurement, and bone marrow analysis (for those with marrow disease at study entry).
Time Frame
Response assessed 60 days post stem cell infusion
Secondary Outcome Measure Information:
Title
Event-free Survival (EFS) at 3 Years
Description
EFS will be measured from start of treatment until progression, death or start of another treatment - whichever comes first. We report the estimated probability of EFS at 3 years.
Time Frame
3 years since start of treatment
Title
Engraftment DLT
Description
• Engraftment toxicity: delayed engraftment and/or failure to engraft defined as: neutrophils (ANC) < 500/μL by day 28 post transplant, or platelets < 20,000 /μL by day 56 post transplant, or if additional stem cells are required to be infused for any medical reason prior to initial engraftment of neutrophils or platelets.
Time Frame
From treatment start until 60 days post stem cell infusion
Title
Dose Limiting Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome SOS
Description
Dose limiting veno-occlusive disease (VOD) defined as: the presence of hepatomegaly with right upper quadrant tenderness and an elevation of total bilirubin > grade 1, PLUS the presence of grade 3 abnormalities of any ONE of the following: total bilirubin, hypoalbuminemia, weight gain, or hypoxia without other attribution
Time Frame
Between start of MIBG treatment and 60 days post stem cell infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of relapsed or refractory neuroblastoma Histologically confirmed and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites High-risk neuroblastoma must meet one of the following: Progressive disease prior to or after completion of induction therapy Mixed response or no response after completion of 4 courses of induction therapy Partial response after 4 courses of induction therapy allowed provided no prior participation in COG-A3973 or other phase III COG trials Measurable disease, defined as at least one metaiodobenzylguanidine (MIBG)-avid target lesion determined by diagnostic MIBG scan within 6 weeks of study entry (tumor sites that have received local irradiation within 3 months of study entry are not considered target lesions) PATIENT CHARACTERISTICS: Performance status Lansky 60-100% OR Karnofsky 60-100% Life expectancy At least 2 months Hematopoietic Hemoglobin ≥ 10 g/dL Absolute neutrophil count ≥ 750/mm^3 Platelet count ≥ 50,000/mm^3 (if no marrow involvement by morphologic exam/no transfusion allowed) (> 20,000/mm^3 if metastatic tumor involvement of marrow by morphologic exam/transfusion allowed) Hepatic Bilirubin < 1.3 mg/dL SGOT and SGPT < 5 times normal Hepatitis B surface antigen negative Hepatitis C negative Renal Glomerular filtration rate or creatinine clearance ≥ 60 ml/min Creatinine ≤ 1.5 times normal for age as follows: 0.8 mg/dL (for patients ≤ 5 years of age) 1.0 mg/dL (for patients 6 to 10 years of age) 1.2 mg/dL (for patients 11 to 15 years of age) 1.5 mg/dL (for patients > 15 years of age) Cardiovascular Ejection fraction ≥ 55% by echocardiogram or radionuclide MUGA OR Fractional shortening ≥ 27% by echocardiogram Pulmonary Normal lung function defined as no dyspnea at rest and no oxygen requirement OR measured oxygen saturation > 93% on room air Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No disease of any major organ system that would preclude study compliance No concurrent hemodialysis No active infection requiring IV antivirals, antibiotics, or antifungals (patients on antifungal therapy are eligible provided they are culture- and biopsy-negative in suspected residual radiographic lesions) Patient weight within limits to receive ≤ maximum total allowable dose of ^131I-MIBG PRIOR CONCURRENT THERAPY: Biologic therapy No prior myeloablative transplantation Prior submyeloablative transplantation allowed at discretion of principal investigator More than 3 weeks since prior biologic therapy Chemotherapy More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for mitomycin C or nitrosoureas) No prior melphalan therapy with a total dose of > 100 mg/m^2 Radiotherapy See Disease Characteristics At least 6 weeks since prior radiotherapy (6 months for craniospinal or whole lung radiotherapy) No prior total body irradiation No prior iodine I 131 MIBG (^131I-MIBG) No prior total abdominal or whole liver radiotherapy No prior local radiotherapy, including any of the following: 1200 cGy to more than 33% of both kidneys (patient must have at least one kidney that has not exceeded the dose/volume of radiation listed) 1800 cGy to more than 30% of liver and/or 900 cGy to more than 50% of liver Other Recovered from all prior therapy No medications with a potential interference of ^131I-MIBG uptake 1 week before and 2 weeks after completion of ^131I-MIBG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Yanik, MD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Katherine K. Matthay, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John M. Maris, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0700
Country
United States
Facility Name
Lucile Packard Children's Hospital at Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago Comer Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
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
Morgan Stanley Children's Hospital of New York-Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
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
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4318
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
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
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
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

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