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Cancer Vaccine

Vaccine + Beta-glucan for Neuroblastoma

Phase 2

Recruiting

Led By Brian Kushner, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed by the MSK Department of Pathology) or BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 32 weeks

Awards & highlights

Study Summary

This trial will test which treatment schedule is best for kids with neuroblastoma in remission to help keep it from coming back.

Who is the study for?

This trial is for people with high-risk neuroblastoma in complete remission. Participants must have a certain level of lymphocytes and neutrophils, be within specific time frames post-therapy, and able to consent. Pregnant individuals or those with severe organ dysfunction, allergies to the vaccine components, or inability to follow protocol are excluded.Check my eligibility

What is being tested?

The study is testing different treatment schedules of β-glucan combined with a bivalent vaccine (OPT-821/QS-21) on patients who have high-risk neuroblastoma but are currently in complete remission. The goal is to find out which schedule might be more effective.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to the vaccine ingredients like KLH and QS-21, as well as general immune responses such as inflammation or discomfort at the injection site. Organ-specific side effects will vary based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My neuroblastoma diagnosis is confirmed by specific tests and criteria.

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My side effects from previous treatments are not severe.

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My neuroblastoma is high-risk based on specific criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 32 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 32 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 32 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean antibody titer in ng/ml of anti-GD2 IgG1 titer

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment2 Interventions

Participants will receive oral β-glucan (40 mg/kg/day) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #7 (~52 weeks), then only one 14-day cycle with each of vaccinations #8-#10.

Group II: Group 1Experimental Treatment2 Interventions

Participants will receive oral β-glucan (40 mg/kg/day) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #5 (~20 weeks), then only one 14-day cycle with each of vaccinations #6-#10.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,804 Total Patients Enrolled

49 Trials studying Neuroblastoma

5,697 Patients Enrolled for Neuroblastoma

Brian Kushner, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

10 Previous Clinical Trials

1,043 Total Patients Enrolled

10 Trials studying Neuroblastoma

1,043 Patients Enrolled for Neuroblastoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Group 1 a hazard to public health?

"According to the Power team, Group 1 has been evaluated with a safety rating of 2 due to the presence of limited data displaying its efficacy and further evidence supporting its security."

Answered by AI

Are there opportunities to participate in this investigation at present?

"Clinicaltrials.gov affirms that this clinical trial is actively enrolling patients, and the latest update was posted on September 21st 2023 - coinciding with its initial posting date."

Answered by AI

How many individuals have enrolled in the trial so far?

"Affirmative. Clinicaltrials.gov provides evidence that this medical trial is currently recruiting individuals. It was first posted on September 21st 2023 and the most recent update happened around the same time, with 94 patients needed from 7 separate clinical sites."

Answered by AI

Are there a range of hospitals administering this experiment within the city limits?

"7 clinical trial sites are available for this study, including Memorial Sloan Kettering Monmouth (Consent Only) in Middletown, Memorial Sloan Kettering Bergen (Consent Only) in Montvale and Memorial Sloan Kettering Suffolk-Commack (Consent only). The other 4 centres can be located on the relevant listings."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06057948.

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