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

Recruiting now · Phase 2

Conditions studied: Neuroblastoma, High-risk Neuroblastoma, Metastatic Neuroblastoma

In brief

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.

Key facts

Study ID

NCT06057948

Run by

Memorial Sloan Kettering Cancer Center

People needed

94

Starts

2023-09-21

Expected to finish

2027-03-21

Last updated by the study team

2026-07-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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