A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma
Key facts
- Where
- Basking Ridge, Commack, Harrison, Middletown, Montvale, New York, and Uniondale, United StatesSee the 7 sites
- Phase
- Phase 2
Where in United States
- Memorial Sloan Kettering at Basking Ridge (Consent Only)Basking Ridge, United StatesTaking people
- Memorial Sloan Kettering Suffolk - Commack (Consent Only)Commack, United StatesTaking people
- Memorial Sloan Kettering Westchester (Consent only)Harrison, United StatesTaking people
- Memorial Sloan Kettering Monmouth (Consent Only)Middletown, United StatesTaking people
- Memorial Sloan Kettering Bergen (Consent Only)Montvale, United StatesTaking people
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, United StatesTaking people
- Memorial Sloan Kettering Nassau (Consent Only)Uniondale, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Memorial Sloan Kettering Cancer Center
- Trial code
- NCT06057948
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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. For those patients with a positive site of disease that is poorly visualized on a scan, it can be per PI discretion to repeat the scan or proceed with enrollment without a recent scan; HR-NB (as defined above) and in 1) first CR at ≥ 6 months from initiation of immunotherapy using anti-GD2 antibody, or 2) second or subsequent CR (achieved after treatment for PD). CR is defined according to the International Neuroblastoma Response Criteria. Patients with positive MIBG scan but negative FDG-PET scan, and CR in BM, are eligible. For those patients with a positive MIBG scan, the negative FDG-PET scan can be per PI discretion to repeat within the 45 day window period prior to enrollment; Patients with grade 3 toxicities or less using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA (CTCAE v5.0) related to hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam. Plus:; Absolute neutrophil count (ANC) ≥ 500/mcl; Absolute lymphocyte count ≥ 500/mcl; >21 and <180 days between completion of systemic therapy and 1st vaccination; A negative pregnancy test is required for patients with child-bearing capability; Signed informed consent indicating awareness of the investigational nature of this program.
Exclusion: Prior treatment with this vaccine; Patients with grade 4 hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam, using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA; History of allergy to KLH, QS-21, OPT-821, or glucan; Active life-threatening infection requiring systemic therapy; Inability to comply with protocol requirements.