Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma

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

Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus etoposide in treating patients who have neuroblastoma.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• High-risk neuroblastoma by:

• Histopathology OR

• Bone marrow involvement plus elevated urinary catecholamines

• Prior tumor progression on standard chemotherapy and poor long-term prognosis as indicated by 1 or more of the following:

• N-myc amplification in tumor cells

• Diploid chromosomal content plus lp loss of heterozygosity in tumor cells

• Distant skeletal metastases

• Unresectable primary tumor infiltrating across the midline

• More than 10% tumor cells in bone marrow

• Less than 30% chance of long-term progression-free survival

• Evaluable (microscopic marrow metastasis, elevated tumor markers, abnormal bone scan or MIBG or PET scan) but not measurable (CT scan, MRI) disease documented at least 4 weeks after completion of prior systemic therapy

• No rapidly progressive disease as defined by 1 or more of the following:

• Serum lactic dehydrogenase greater than 1.5 times upper limit of normal due to tumor

• An opiate requirement for pain from tumor

• Greater than 25% increase in tumor by successive imaging studies

• Life expectancy less than 8 weeks

• Second or subsequent remission after chemotherapy and/or radiotherapy allowed provided there is less than 30% chance of survival

• No prior myelodysplastic syndromes or leukemia

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Not specified

Life expectancy:

• See Disease Characteristics

• At least 8 weeks

Hematopoietic:

• Not specified

Hepatic:

• No grade 3 or worse liver toxicity

Renal:

• No grade 3 or worse renal toxicity

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No grade 3 or worse cardiac toxicity

Pulmonary:

• No grade 3 or worse pulmonary toxicity

Other:

• Not pregnant

• No grade 3 or worse gastrointestinal toxicity

• No grade 3 or worse neurologic system toxicity

• No grade 4 hearing deficit

• No active life-threatening infection

• No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL

• No allergy to mouse proteins

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• See Disease Characteristics