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

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