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

Neuroblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06057948
• Other study ID #: 23-198
• Status: Recruiting
• Phase: Phase 2
• Start date: September 21, 2023
• Est. completion date: March 21, 2026

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Brian Kushner, MD
• Phone: 1-833-MSK-KIDS
• Email: kushnerb[@]MSKCC.ORG
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: March 21, 2026
• Est. primary completion date: March 21, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• High-risk Neuroblastoma
• Metastatic Neuroblastoma
• Neuroblastoma

Intervention

Biological:
• OPT-821 (QS-21)
Comprised of the immunological adjuvant OPT-821 (QS-21)

Dietary Supplement:
• oral ß-glucan
Participants will be randomized to receive this agent in two different schedules

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge (Consent only)	Basking Ridge	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 Monmouth (Consent Only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent Only)	Montvale	New Jersey
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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean antibody titer in ng/ml of anti-GD2 IgG1 titer	To determine the effect of oral ß-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.	up to 32 weeks

External Links

•   Memorial Sloan Kettering Cancer Center