Biological Therapy in Treating Patients With Neuroblastoma That Has Not Responded to Previous Treatment

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

Summary

RATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Beta-glucan, isotretinoin, and sargramostim may increase the effectiveness of monoclonal antibody 3F8 by making tumor cells more sensitive to the monoclonal antibody. Combining different types of biological therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving beta-glucan, isotretinoin, and sargramostim together with monoclonal antibody 3F8 works in treating patients with neuroblastoma that has not responded to previous treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins; Isotretinoin; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of neuroblastoma, as defined by 1 of the following:

• Histologically confirmed disease

• Bone marrow metastases plus high urine catecholamines

• High-risk disease meeting 1 of the following stage criteria:

• Stage IV, with 1 of the following:

• Any age with MYCN amplification

• > 18 months of age without MYCN amplification

• Stage III, with both of the following:

• Any age with MYCN amplification

• Unresectable disease

• Stage 4S with MYCN amplification

• Measurable or evaluable soft tissue disease

• Relapsed disease resistant to standard induction chemotherapy and salvage therapy

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No severe hepatic toxicity ≥ grade 3

Renal

• No severe renal toxicity ≥ grade 3

Cardiovascular

• No severe cardiac toxicity ≥ grade 3

Pulmonary

• No severe pulmonary toxicity ≥ grade 3

Other

• Not pregnant

• Negative pregnancy test

• No severe neurologic toxicity ≥ grade 3

• No severe gastrointestinal toxicity ≥ grade 3

• No other severe major organ dysfunction except ototoxicity

• No history of allergy to mouse proteins

• No active life-threatening infection

• No human anti-mouse antibody titer > 1,000 ELISA units/mL

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified