Status:
COMPLETED
Biological Therapy in Treating Patients With Neuroblastoma That Has Not Responded to Previous Treatment
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. Beta-glucan, is...
Detailed Description
OBJECTIVES: * Determine the efficacy of beta-glucan, isotretinoin, and sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk refractory neuroblastoma...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of neuroblastoma, as defined by 1 of the following:
- Histologically confirmed disease
- Bone marrow metastases plus high urine catecholamines
- High-risk disease meeting 1 of the following stage criteria:
- Stage IV, with 1 of the following:
- Any age with MYCN amplification
- \> 18 months of age without MYCN amplification
- Stage III, with both of the following:
- Any age with MYCN amplification
- Unresectable disease
- Stage 4S with MYCN amplification
- Measurable or evaluable soft tissue disease
- Relapsed disease resistant to standard induction chemotherapy and salvage therapy
- PATIENT CHARACTERISTICS:
- Age
- Any age
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- No severe hepatic toxicity ≥ grade 3
- Renal
- No severe renal toxicity ≥ grade 3
- Cardiovascular
- No severe cardiac toxicity ≥ grade 3
- Pulmonary
- No severe pulmonary toxicity ≥ grade 3
- Other
- Not pregnant
- Negative pregnancy test
- No severe neurologic toxicity ≥ grade 3
- No severe gastrointestinal toxicity ≥ grade 3
- No other severe major organ dysfunction except ototoxicity
- No history of allergy to mouse proteins
- No active life-threatening infection
- No human anti-mouse antibody titer \> 1,000 ELISA units/mL
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00089258
Start Date
July 1 2004
Last Update
January 17 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021