I-Metaiodobenzylguanidine (MIBG) With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

Inclusion 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