Expired Study
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New York, New York 10065


Purpose:

RATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Combining monoclonal antibody 3F8 with sargramostim may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with sargramostim in treating patients who have neuroblastoma.


Study summary:

OBJECTIVES: - Determine the efficacy of sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk neuroblastoma. - Determine the prognostic impact of minimal residual bone marrow disease on relapse-free survival of patients treated with this regimen. - Compare the effects of short-term (2-hour intravenous) vs prolonged (subcutaneous release) daily GM-CSF on granulocyte activation, in order to establish the optimal route for tumor-cell kill in these patients. OUTLINE: This is an open-label study. Patients are stratified according to evaluable disease (yes [primary refractory bone marrow disease] vs no [no evidence of disease]). Patients receive sargramostim (GM-CSF) subcutaneously on days -5 to 4 and monoclonal antibody 3F8 IV over 0.5-1.5 hours on days 0-4. Treatment repeats every 3 weeks for 4 courses and then every 8 weeks for up to a total of 24 months in the absence of disease progression or unacceptable toxicity. Beginning after 2 courses of GM-CSF and monoclonal antibody 3F8, patients also receive oral isotretinoin twice daily on days 1-14 (when no monoclonal antibody 3F8 is administered). Treatment with isotretinoin repeats approximately every 28 days for 6 courses. PROJECTED ACCRUAL: A total of 340 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine catecholamine levels - Disease must meet risk-related treatment guidelines and any of the following International Neuroblastoma Staging System stages: - Stage 4 with (any age) OR without (> 18 months of age of age) MYCN amplification - MYCN-amplified other than stage 1 - No evidence of disease (i.e., in complete response/remission or very good partial response/remission) OR disease resistant to standard therapy (i.e., incomplete response in bone marrow) - No progressive disease or MIBG-avid soft tissue tumor PATIENT CHARACTERISTICS: - No existing renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3 - No human anti-mouse antibody (HAMA) titer greater than 1,000 Elisa units/mL - No history of allergy to mouse proteins - No active life-threatening infection - Not pregnant - Negative pregnancy test PRIOR CONCURRENT THERAPY: - Not specified


NCT ID:

NCT00072358


Primary Contact:

Principal Investigator
Brian H. Kushner, MD
Memorial Sloan Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10065
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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