Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

Study Overview
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Brief Summary
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RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma.

Detailed Description
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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.

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

Conditions
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Neuroblastoma

Intervention / Treatment
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* Biological: monoclonal antibody 3F8
* Biological: sargramostim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: monoclonal antibody 3F8|nan|
|Biological: sargramostim|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent neuroblastoma