At a glance
ClinicalIndex Comparison Record- ✓Histopathological diagnosis of neuroblastoma OR bone marrow metastases with elevated urine catecholamines
- ✓Stage 4 disease (any age) OR Stage 4 without MYCN amplification (age >18 months) OR MYCN-amplified disease other than stage 1
- ✓Disease in complete or very good partial response/remission OR resistant to standard therapy with incomplete bone marrow response
- ✓No progressive disease and no MIBG-avid soft tissue tumor
- ✕Grade 3 or higher renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity
- ✕Human anti-mouse antibody (HAMA) titer >1,000 Elisa units/mL
- ✕History of allergy to mouse proteins
- ✕Active life-threatening infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Anti-GD2 3F8 Antibody and GM-CSF for High-Risk Neuroblastoma
In Brief
A Phase 2 clinical trial evaluating anti-GD2 murine IgG3 monoclonal antibody 3F8 for Neuroblastoma. Completed, enrolled 291 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The total dosage of 3F8 per cycle is the same as in prior trials (100 mg/m2), administered at 20 mg/m2/day and infused over \~1.5 hr or less (0.5 hr is customary), with analgesics and antihistamines used as needed for expected side-effects. 3F8 is started \~1 hr after completion of GM-CSF administration. GM-CSF is dosed at 250 mcg/m2/day from day -5 to day +1 (Wednesday to Tuesday is customary) , and is 500 mcg/m2/day thereafter (i.e., on days +2 to +4; Wednesday to Friday), as in the predecessor protocol.18,74 Patients come off study if progressive disease occurs or if there is life-threatening grade 4 toxicity from 3F8; otherwise, patients will receive a minimum of 4 cycles of treatment and will continue treatment through 24 months. It is expected that patients will receive \~10 cycles.
The total dosage of 3F8 per cycle is the same as in prior trials (100 mg/m2), administered at 20 mg/m2/day and infused over \~1.5 hr or less (0.5 hr is customary), with analgesics and antihistamines used as needed for expected side-effects. 3F8 is started \~1 hr after completion of GM-CSF administration. GM-CSF is dosed at 250 mcg/m2/day from day -5 to day +1 (Wednesday to Tuesday is customary) , and is 500 mcg/m2/day thereafter (i.e., on days +2 to +4; Wednesday to Friday), as in the predecessor protocol.18,74 Patients come off study if progressive disease occurs or if there is life-threatening grade 4 toxicity from 3F8; otherwise, patients will receive a minimum of 4 cycles of treatment and will continue treatment through 24 months. It is expected that patients will receive \~10 cycles.