Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma
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.
|Neuroblastoma||Biological: monoclonal antibody 3F8 Biological: sargramostim||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA|
|Study Start Date:||February 1994|
|Study Completion Date:||April 2005|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002560
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Brian H. Kushner, MD||Memorial Sloan Kettering Cancer Center|