A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma
NCT ID: NCT06057948
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
94 participants
INTERVENTIONAL
2023-09-21
2026-03-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Participants will receive oral β-glucan (40 mg/kg/day) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #5 (\~20 weeks), then only one 14-day cycle with each of vaccinations #6-#10.
OPT-821 (QS-21)
Comprised of the immunological adjuvant OPT-821 (QS-21)
oral β-glucan
Participants will be randomized to receive this agent in two different schedules
Group 2
Participants will receive oral β-glucan (40 mg/kg/day) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #7 (\~52 weeks), then only one 14-day cycle with each of vaccinations #8-#10.
OPT-821 (QS-21)
Comprised of the immunological adjuvant OPT-821 (QS-21)
oral β-glucan
Participants will be randomized to receive this agent in two different schedules
Interventions
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OPT-821 (QS-21)
Comprised of the immunological adjuvant OPT-821 (QS-21)
oral β-glucan
Participants will be randomized to receive this agent in two different schedules
Eligibility Criteria
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Inclusion Criteria
* 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 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.
* 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 Criteria
* History of allergy to KLH, QS-21, OPT-821, or glucan
* Prior treatment with this vaccine.
* Active life-threatening infection requiring systemic therapy.
* Inability to comply with protocol requirements.
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Brian Kushner, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (Consent only)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Brian Kushner, MD
Role: primary
Brian Kushner, MD
Role: primary
Brian Kushner, MD
Role: primary
Brian Kushner, MD
Role: primary
Brian Kushner, MD
Role: primary
Brian Kushner, MD
Role: primary
Brian Kushner, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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23-198
Identifier Type: -
Identifier Source: org_study_id