Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

Memorial Sloan Kettering Cancer Center40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Neuroblastoma

Interventions

monoclonal antibody 3F8BIOLOGICAL

sargramostimBIOLOGICAL

Eligibility

Sex: ALLMin age: 2 YearsMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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