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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 32 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Effect of GM-CSF on anti-GD2 antibody titers

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

~1340

OPT-821

2010

Completed Phase 2

~140

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,617 Total Patients Enrolled

49 Trials studying Neuroblastoma

5,527 Patients Enrolled for Neuroblastoma

Brian Kushner, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

10 Previous Clinical Trials

873 Total Patients Enrolled

10 Trials studying Neuroblastoma

873 Patients Enrolled for Neuroblastoma

Media Library

OPT-821 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04936529 — Phase 2

Neuroblastoma Research Study Groups: Group 3, Group 1, Group 2

Neuroblastoma Clinical Trial 2023: OPT-821 Highlights & Side Effects. Trial Name: NCT04936529 — Phase 2

OPT-821 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04936529 — Phase 2

Frequently Asked Questions

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

Has β-glucan been evaluated for medical purposes in the past?

"Presently, there is one extant β-glucan study in operation. This particular trial has yet to reach Phase 3 and is being conducted exclusively at medical centres located within New york City."

Answered by AI

Is the enrollment phase of this research project currently open?

"Affirmative. According to clinicaltrials.gov, this medical trial which began on August 2nd 2021 is still seeking participants. 264 patients need to be recruited from a single site for the experiment's completion."

Answered by AI

What is the cap for recruitment into this medical investigation?

"Indeed, the information hosted on clinicaltrials.gov reveals that this research is actively looking for participants since it was posted in August 2021 and recently updated October 2022. This investigation requires 264 individuals to be recruited from a single trial centre."

Answered by AI

Has the US Food and Drug Administration authorized β-glucan for general consumption?

"Our research team at Power assigned β-glucan a score of 2 based on the available evidence, as no clinical data has been collected to assess its efficacy yet. However, there is some existing information indicating that it may be safe for human consumption."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma

2021. "A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04936529.

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