N99-01: Combination Chemotherapy, Radiation Therapy, and Stem Cell Transplantation in Treating Patients With Neuroblastoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy.

PURPOSE: This phase I trial is studying the side effects and best dose of combination chemotherapy when given before stem cell transplant and radiation therapy in treating patients with neuroblastoma that has not responded to previous treatments.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Approaches to Neuroblastoma Therapy Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: 3-Iodobenzylguanidine; Carboplatin; Etoposide; Melphalan

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