N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
Neuroblastoma
About this trial
This is an interventional treatment trial for Neuroblastoma focused on measuring recurrent neuroblastoma
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
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
Experimental
All the patients enrolled in the study
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.