RecruitingPhase 2NCT06057948

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

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

94 participants

Start Date

Sep 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing whether a vaccine combined with beta-glucan (a natural immune-stimulating compound) can help prevent neuroblastoma — a childhood cancer — from returning in children and young adults who have achieved remission after intensive treatment. **You may be eligible if...** - You have been diagnosed with high-risk neuroblastoma as defined by international criteria (e.g., spread beyond the primary site, MYCN gene amplification) - You are in first complete remission (at least 6 months after starting immunotherapy with anti-GD2) or in second or subsequent complete remission - You meet standard performance and organ function criteria **You may NOT be eligible if...** - You have active (not in remission) neuroblastoma - You have serious organ dysfunction or active infections - You have had prior bone marrow transplant that would prevent participation - You have had certain specific prior treatments that conflict with this protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALOPT-821 (QS-21)

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

DIETARY_SUPPLEMENToral β-glucan

Participants will be randomized to receive this agent in two different schedules


Locations(7)

Memorial Sloan Kettering at Basking Ridge (Consent only)

Basking Ridge, New Jersey, 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 Suffolk-Commack (Consent only)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 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, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06057948


Related Trials