PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA

Inclusion Criteria

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