Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00002560


Primary Contact:

Study Chair
Brian H. Kushner, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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