Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuroblastoma
Intervention: anti-GD2 murine IgG3 monoclonal antibody 3F8 (Biological); anti-GD2 murine IgG3 monoclonal antibody 3F8 (Biological)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Memorial Sloan Kettering Cancer Center Official(s) and/or principal investigator(s): Brian H. Kushner, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center
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-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.
Clinical Details
Official title: Phase II Study of Anti-GD2 3F8 Antibody and GM-CSF for High-Risk Neuroblastoma
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Efficacy at completion of treatmentRelapse-free survival every 3 months
Secondary outcome: Compare granulocyte activation in patients treated with short-term vs prolonged daily exposure to sargramostim (GM-CSF) after 4 coursesSimplify treatment with consequent reduction in cost
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 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 2003
Last updated: July 21, 2015
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