Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

OBJECTIVES:

• Define the antitumor effects of monoclonal antibody 3F8/sargramostim (3F8/GM-CSF) in patients with advanced neuroblastoma.
• Assess the biological effects of 3F8/GM-CSF in these patients.

OUTLINE: Patients receive monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11 and sargramostim (GM-CSF) IV over 2 hours on days -5 to 11. Treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease, HAMA response, or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 11-40 patients will be accrued for this study over 4 years.

DISEASE CHARACTERISTICS:

• Neuroblastoma diagnosed by INSS criteria, i.e., either:

• Histologic proof of disease OR
• Tumor clumps in bone marrow plus elevated catecholamine levels
• Relapsed disease with poor long-term prognosis as indicated by at least one of the following:

• N-myc amplification in tumor cells
• Diploid chromosomal content in tumor cells
• Distant skeletal metastases
• Unresectable primary tumor crossing the midline
• Bone marrow with greater than 10% tumor cells
• Documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required
• No rapidly progressive disease
• Poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols

PATIENT CHARACTERISTICS:

Age:

• 2 to 21

Performance status:

• Not specified

Life expectancy:

• Greater than 8 weeks

Hematologic:

• Not specified

Hepatic:

• No grade 3/4 toxicity
• LDH no greater than 1.5 times upper limit of normal

Renal:

• Creatinine clearance at least 60 mL/min
• No grade 3/4 toxicity

Cardiovascular:

• No grade 3/4 toxicity

Pulmonary:

• No grade 3/4 toxicity

Other:

• No grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit
• No active life threatening infections
• No human antimouse antibody (HAMA) greater than 1,000 ELISA units/mL
• No allergy to mouse proteins
• No pain requiring opiates

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified