Testing a vaccine with beta-glucan for high-risk neuroblastoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a treatment schedule combining a bivalent vaccine with β-glucan in patients diagnosed with high-risk neuroblastoma who are in complete remission. Participants will receive OPT-821 (QS-21) along with oral β-glucan to determine the most effective treatment regimen. The study focuses on patients who meet specific criteria for high-risk neuroblastoma, including those with MYCN amplification or metastatic disease. The goal is to improve treatment outcomes for this challenging pediatric cancer.

Why it matters

Who can join: the full rules

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. 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 Criteria:

* 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.

Where it's running

• Memorial Sloan Kettering at Basking Ridge (Consent only)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Consent Only)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Consent Only)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (Consent only)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Consent only)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Brian Kushner, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Brian Kushner, MD
• Email: kushnerb@MSKCC.ORG
• Phone: 1-833-MSK-KIDS

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.