Actively Recruiting
Phase 2 Study of a Bivalent Vaccine with OPT-821, Oral Beta-Glucan, and GM-CSF for High-Risk Neuroblastoma in Remission
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-08-11
286
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are exploring a combination treatment involving a bivalent vaccine, beta-glucan, and granulocyte-macrophage colony stimulating factor GM-CSF for people with high-risk neuroblastoma who are in complete remission. This Phase II trial evaluates how these components might boost the immune systems response to fight cancer cells more effectively. Participants are divided into three groups. Group 1 receives oral beta-glucan in cycles starting at week 1 with annual booster vaccinations but does not receive GM-CSF. Group 2 receives oral beta-glucan plus GM-CSF administered for specific days alongside vaccinations, following a detailed schedule including annual boosters. Group 3 includes participants unable to be randomized or previously treated they receive treatment similar to Group 1 with some variations in vaccine dosing. Vaccine injections are spaced at least six days apart, with some flexibility after initial doses. During the study, participants will have regular vaccinations and oral beta-glucan cycles over several years, with monitoring of immune responses, especially anti-GD2 antibody levels at 32 weeks. Safety and recovery from prior treatments are assessed before enrollment. The study allows repeat enrollment for certain participants. The total study duration includes multiple vaccine cycles and follow-ups up to five years, with continuous evaluation of immune effects and safety.
CONDITIONS
Brief Title
A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma
Research Team
B
Brian Kushner, MD
F
Fiorella Iglesias Cardenas, MD, MS
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