Testing a vaccine with beta-glucan for high-risk neuroblastoma patients
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
PHASE2 · Memorial Sloan Kettering Cancer Center · NCT06057948
This study is testing a new vaccine combined with a substance called beta-glucan to see if it can help children with high-risk neuroblastoma who are in complete remission.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06057948 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include children diagnosed with high-risk neuroblastoma in complete remission after prior immunotherapy.
Not a fit: Patients with low-risk neuroblastoma or those not in complete remission may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance remission rates and improve survival outcomes for children with high-risk neuroblastoma.
How similar studies have performed: Previous studies have shown promise in using immunotherapy and adjunct treatments like β-glucan for neuroblastoma, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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: * 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 this trial is running
Basking Ridge, New Jersey and 6 other locations
- 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)
- Memorial Sloan Kettering Nassau (Consent Only) — Uniondale, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuroblastoma, High-risk Neuroblastoma, Metastatic Neuroblastoma, HR-NB, Memorial Sloan Kettering Cancer Center, 23-198