Back to search results

Study of a Vaccine and Beta-glucan for Neuroblastoma

This study is testing a new approach for people with high-risk neuroblastoma that is in complete remission. It combines a vaccine called OPT-821 (QS-21) with a dietary supplement called oral β-glucan. The goal is to see which schedule of β-glucan works best with the vaccine to boost the body's immune response (immunotherapy). Researchers will measure the amount of a specific antibody (anti-GD2 IgG1 titer) in your blood for up to 32 weeks to see how well the treatment is working. To join, you must have a diagnosis of neuroblastoma and high-risk neuroblastoma based on international criteria. The current recruitment status is unclear, and the study plans to enroll 94 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. Participants will be randomly assigned to receive oral β-glucan on one of two different schedules.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures are taken for up to 32 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06057948

A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma

Recruiting
PHASE2All AgesInterventionalTreatment
Memorial Sloan Kettering Cancer Center
~94 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:OPT-821 (QS-21)oral β-glucan

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean antibody titer in ng/ml of anti-GD2 IgG1 titer
Measured over up to 32 weeks

Conditions

Neuroblastoma
High-risk Neuroblastoma
Metastatic Neuroblastoma

Explore related trials

NeuroblastomaMYCN Gene

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Brian Kushner, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Brian Kushner, MD
[email protected]
1-833-MSK-KIDS
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

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.
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

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
Prior treatment with this vaccine.
Active life-threatening infection requiring systemic therapy.
Inability to comply with protocol requirements.

What this trial measures

  • Mean antibody titer in ng/ml of anti-GD2 IgG1 titerup to 32 weeks

    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.