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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.

Must not have

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.

Prior treatment with this vaccine.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 32 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood tests and physical exams show no severe issues with my heart, lungs, kidneys, liver, or blood.

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I have previously received this vaccine.

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I do not have a severe infection needing treatment through my veins.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met