Status:
COMPLETED
Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neuroblastoma
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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-stimulat...
Detailed Description
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 min...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2021
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT00072358
Start Date
July 1 2003
End Date
January 15 2021
Last Update
May 16 2022
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065