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Cancer Vaccine

Vaccine + β-glucan + GM-CSF 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

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. Hematologic Function: Absolute neutrophil count (ANC) ≥ 500/mcl, Absolute lymphocyte count ≥ 500/mcl, Hemoglobin (Hgb) ≥ 8 g/dL, Platelet count ≥ 50,000 mm^3. Renal Function: Serum creatinine ≤ 3.0 x ULN or eGFR >60 mL/min/1.73 m^2. Hepatic Function: Serum bilirubin ≤ 3.0 × ULN, Aspartate transaminase (AST) ≤ 5.0 × ULN, Alanine aminotransferase (ALT) ≤ 5.0 × ULN

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

Must not have

Patients with significant (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 (CTCAE v5.0)

Active life-threatening infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 32 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of three things - a vaccine, a sugar, and a protein - to see if it can effectively treat high-risk neuroblastoma in people who are in complete remission.

Who is the study for?

This trial is for people with high-risk neuroblastoma in complete remission. Participants must have a confirmed diagnosis, be within certain time frames post-therapy, and have adequate organ function. Pregnant individuals or those with severe allergies to the study drugs, significant organ dysfunction, or life-threatening infections cannot join.

What is being tested?

The study tests a combination of a bivalent vaccine with β-glucan (a sugar) and GM-CSF (a protein) to boost the immune system against neuroblastoma cancer cells. The treatment aims to improve the body's natural defense by using different mechanisms.

What are the potential side effects?

Potential side effects may include reactions related to strengthening the immune response such as inflammation, fatigue, digestive issues, blood disorders but specifics are not provided in this summary.

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 lab tests and high urine catecholamine levels.

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My neuroblastoma is high-risk based on specific genetic features and its spread.

Exclusion Criteria

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

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My major organs are functioning well, without severe issues.

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I am currently being treated for a severe infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 32 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~32 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Effect of GM-CSF on anti-GD2 antibody titers

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3Experimental Treatment2 Interventions

Group 3 will include participants who cannot be randomized (e.g., due to allergy to GMCSF). It will also include participants previously treated with this vaccine and oral β-glucan on the predecessor MSK protocol IRB# 05-075 or on this protocol (participants can therefore be enrolled more than one time on this protocol). These participants will be treated as in Group 1. Participants who are registered to Group 3 and have been previously treated with vaccine (in this protocol or MSK predecessor 05-075) will not receive vaccines 4 and 6. These patients will receive a total of 8 injections. The analyses in this group will be exploratory.

Group II: Group 2Experimental Treatment3 Interventions

Group 2 participants receive oral β-glucan (40 mg/kg/day) starting week 1. Participants also receive GM-CSF (250 mcg/m2/day) x3 days with vaccinations #1-#3; x7 days with vaccinations #4-#9; and x5 days with vaccination #10. The treatment includes annual booster vaccinations, with a 2-week cycle of β-glucan, administered at weeks 8, 20, 32, 52, 78, 104, and 156 (vaccinations #1 \& #4-10)

Group III: Group 1Experimental Treatment2 Interventions

Group 1 participants receive oral β-glucan (40 mg/kg/day x 14 days) starting week 1. This schedule includes annual booster vaccinations, with β-glucan, administered at weeks 8, 20, 32, 52, 78, 104, and 156 (vaccinations #1 \& #4-10). Participants will not receive GM-CSF.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GM-CSF

2014

Completed Phase 4

~1350

OPT-821

2010

Completed Phase 2

~140