N2000-01: Double Infusion of Iodine I 131 Metaiodobenzylguanidine Followed by Autologous Stem Cell Transplantation
Neuroblastoma

About this trial
This is an interventional treatment trial for Neuroblastoma focused on measuring recurrent neuroblastoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of neuroblastoma Confirmed by at least 1 of the following methods: Histology Clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites High-risk disease Poor response to induction therapy OR relapse defined by any of the following: No response, stable disease, or mixed response after a minimum of 3 prior courses of chemotherapy More than 100 tumor cells per 10^5 nucleated cells on bone marrow immunocytology after at least 3 prior courses of chemotherapy Progressive disease at any time during or after therapy Patients with massive bone marrow invasion (more than 50% replacement of bone marrow by tumor cells) are allowed Must have positive iodine I 131 metaiodobenzylguanidine (^131I-MIBG) within the past 6 weeks or subsequent to any other prior antitumor therapy delivered within the past 6 weeks Must meet the following criteria for minimum number of autologous stem cells: Unpurged peripheral blood stem cells (PBSC) Minimum of 1,500,000/mm^3 CD34-positive cells/kg Collected products must have < 1 tumor cell/100,000 normal cells by immunocytology PBSC purged with immunomagnetic beads Minimum of 1,000,000/mm^3 viable CD34-positive cells/kg Collected products must have < 1 tumor cell/100,000 normal cells by immunocytology CD34-positive selected PBSC products are not allowed Patients who had PBSC collected previously with no immunocytological testing available may use those products provided bone marrow is tumor free by bilateral bone marrow aspirate AND biopsy for morphology is performed within 4 weeks before PBSC collection Patients with no tumor involvement in bone marrow at diagnosis and PBSC collection before any disease progression do not require documentation of negative bone marrow morphology PATIENT CHARACTERISTICS: Age 1 to 30 Performance status ECOG 0-2 Life expectancy Less than 1 year Hematopoietic Absolute neutrophil count ≥ 500/mm^3 Platelet count ≥ 50,000/mm^3 (without transfusion) Hemoglobin ≥ 8 g/dL (transfusion allowed) Hepatic AST and ALT ≤ 5 times normal Bilirubin < 2 times normal Renal Creatinine ≤ 1.5 mg/dL Glomerular filtration rate OR 12-hour creatinine clearance ≥ 60 mL/min/1.73m^2 Cardiovascular Ejection fraction ≥ 55% by echocardiogram or MUGA OR Fractional shortening ≥ 30% OR above lower limit of normal by echocardiogram Pulmonary Normal lung function No dyspnea at rest No exercise intolerance No oxygen requirement Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able to cooperate physically and psychologically with radiation isolation No disease of any major organ system that would preclude study participation No active infection requiring antivirals, antibiotics, or antifungals No weight that would require exceeding a maximum total allowable dose of ^131I-MIBG PRIOR CONCURRENT THERAPY: Biologic therapy At least 2 weeks since prior biologic or other non-myelosuppressive therapy Chemotherapy See Disease Characteristics At least 2 weeks since prior chemotherapy More than 3 months since prior myeloablative therapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 6 months since prior craniospinal, total abdominal, or whole lung radiotherapy At least 2 weeks since prior radiotherapy to any site No prior total body irradiation No prior radiotherapy to > 25% of bone marrow No prior ^131I-MIBG Surgery Not specified Other Recovered from all prior therapy Concurrent antifungal therapy allowed provided culture and biopsy are negative in suspected radiographic lesions Prior re-induction therapy for recurrent tumor allowed No concurrent antiretroviral therapy for HIV-positive patients No concurrent hemodialysis
Sites / Locations
- Children's Hospital Los Angeles
- UCSF Comprehensive Cancer Center
- Indiana University Cancer Center
- Children's Hospital Boston
- Cincinnati Children's Hospital Medical Center
- Children's Hospital of Philadelphia
- University of Wisconsin Comprehensive Cancer Center