N99-01: Combination Chemotherapy, Radiation Therapy, and Stem Cell Transplantation in Treating Patients With Neuroblastoma
Neuroblastoma
About this trial
This is an interventional treatment trial for Neuroblastoma focused on measuring localized resectable neuroblastoma, regional neuroblastoma, disseminated neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma, localized unresectable neuroblastoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of neuroblastoma as evidenced by one of the following: Histological confirmation Demonstrates clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites High-risk refractory or residual disease Poorly responding disease, meeting 1 of the following criteria: Stable disease or partial response after at least 12 weeks of induction therapy Bone marrow containing greater than 100 tumor cells per 100,000 normal cells after 12 weeks of induction therapy Progressive disease during or after therapy At least 1 prior positive iodine I 131 metaiodobenzylguanidine (131 I-MIBG) scan since diagnosis and meets disease status criteria PATIENT CHARACTERISTICS: Age: 1 to 21 (1 to 20 at diagnosis) Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Absolute neutrophil count at least 500/mm^3 Platelet count at least 20,000/mm^3 (transfusion allowed) Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic: Bilirubin normal AST/ALT no greater than 3 times normal No active hepatitis (for HIV-positive patients only) Renal: Glomerular filtration rate or creatinine clearance at least 60 mL/min Creatinine less than 1.5 times normal for age Cardiovascular: Ejection fraction at least 55% OR Fractional shortening at least 30% Pulmonary: No dyspnea at rest or exercise intolerance No requirement for supplemental oxygen No active pneumonia (for HIV-positive patients only) Other: No disease of any major organ system that would preclude study participation No other active health problems (for HIV-positive patients only) No active infections requiring intravenous antivirals, antibiotics, or antifungals Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy and recovered Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No more than 100 mg/m^2 total dose of prior melphalan Endocrine therapy: Not specified Radiotherapy: No prior total body, whole abdominal, or whole liver irradiation No prior therapy with 131 I-MIBG At least 2 weeks since prior radiotherapy (6 months for prior radiotherapy to craniospinal or whole lung fields or greater than 50% of bone marrow space) and recovered Surgery: Prior surgical resection allowed Recovered from prior surgery Other: No prior myeloablative therapy Prior submyeloablative therapy with peripheral blood stem cell support allowed No concurrent antiretrovirals for HIV-positive patients Concurrent prolonged antifungal allowed if culture and biopsy negative in suspected residual radiographic lesions No medications that may preclude uptake of 131 I-MIBG for 1 week prior and 2 weeks after administration of study drugs No concurrent hemodialysis
Sites / Locations
- Children's Hospital Los Angeles
- Lucile Packard Children's Hospital at Stanford University Medical Center
- UCSF Comprehensive Cancer Center
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
- Children's Memorial Hospital - Chicago
- Indiana University Cancer Center
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- Children's Hospital Boston
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- University of Michigan Comprehensive Cancer Center
- Cincinnati Children's Hospital Medical Center
- Children's Hospital of Philadelphia
- Texas Children's Cancer Center
- Children's Hospital and Regional Medical Center - Seattle
- University of Wisconsin Comprehensive Cancer Center