Combination Chemotherapy With or Without Filgrastim Before Surgery, High-Dose Chemotherapy, and Radiation Therapy Followed by Isotretinoin With or Without Monoclonal Antibody in Treating Patients With Neuroblastoma

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

Summary

RATIONALE: Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining isotretinoin and monoclonal antibodies may kill any remaining tumor cells following surgery. It is not yet known which treatment regimen is more effective in treating neuroblastoma.

PURPOSE: This randomized phase III trial is studying how well combination chemotherapy with or without filgrastim before surgery, high-dose chemotherapy, and radiation therapy followed by isotretinoin with or without monoclonal antibody work in treating patients with neuroblastoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leicester
• Treatments: Antibodies; Antibodies, Monoclonal; Busulfan; Carboplatin; Cyclophosphamide; Dinutuximab; Etoposide; Immunoglobulins; Isotretinoin; Lenograstim; Melphalan; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of neuroblastoma according to International Neuroblastoma Staging System

• Stage 2 or 3 with MycN amplification

• Stage 4

• Tumor material available for determination of biological prognostic factors

PATIENT CHARACTERISTICS:

Age:

• 1 to 20 at diagnosis

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than 3 times normal

• ALT less than 3 times normal

Renal:

• Creatinine less than 1.5 mg/mL

• Creatinine clearance and/or glomerular filtration rate at least 60 mL/min

Cardiovascular:

• Shortening fraction at least 28% OR

• Ejection fraction at least 55%

• No clinical congestive heart failure

Pulmonary:

• Chest x-ray normal

• Oxygen saturation normal

Other:

• HIV negative

• No Brock grade 2 or greater

• No uncontrolled infections requiring IV antivirals, antibiotics, or antifungals

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No more than 1 prior chemotherapy regimen for localized unresectable disease

• No concurrent anthracyclines

• No other concurrent chemotherapy

Endocrine:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No other concurrent investigational therapy