Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821 (QS-21), in Combination With Randomization of Oral β-glucan, for High-Risk Neuroblastoma
Summary
The purpose of this study is to test which treatment schedule of β-glucan with bivalent vaccine is more effective for participants with high-risk neuroblastoma that is in complete remission.
Arms & interventions
- BiologicalOPT-821 (QS-21)
Comprised of the immunological adjuvant OPT-821 (QS-21)
- Dietary Supplementoral β-glucan
Participants will be randomized to receive this agent in two different schedules
Outcome measures
Primary
Mean antibody titer in ng/ml of anti-GD2 IgG1 titer
To determine the effect of oral β-glucan schedule on anti-GD2 antibody titers among patients who are in first or second (or later) CR, i.e., have no evidence of neuroblastoma by standard studies.
Time frame: up to 32 weeks
Eligibility criteria
Study locations (7)
Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Suffolk-Commack (Consent only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553