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
Memorial Sloan Kettering Cancer Center
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.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of NB as defined by international criteria,102 i.e., histopathology (confirmed by the MSK Department of Pathology) or BM metastases plus high urine catecholamine levels, or positivity in MIBG scan. * HR-NB as defined by risk-related treatment guidelines and international criteria,102 i.e., metastatic/non-localized disease with MYCN amplification (any age), metastatic disease \>18 months old, MYCN-amplified localized disease (any age), or disease resistant to standard chemotherapy. * HR-NB (as defined above) and in 1) first CR at ≥ 6 months from initiation of im…
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
Locations (7)
- Memorial Sloan Kettering at Basking Ridge (Consent only)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Consent Only)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Consent Only)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (Consent only)Commack, New York
- Memorial Sloan Kettering Westchester (Consent only)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York