N2001-02: I-Metaiodobenzylguanidine (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