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Cancer Vaccine

Vaccine + Immunological Adjuvant for Neuroblastoma

Phase 1 & 2

Waitlist Available

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

High-risk NB as defined by risk-related treatment guidelines and the International NB Staging System, i.e., stage 4 with MYCN amplification (any age) stage 4 >18 months old.

Diagnosis of neuroblastoma (NB) as defined by international criteria,[104] i.e., histopathology (confirmed by the MSKCC Department of Pathology) or bone marrow metastases plus high urine catecholamine levels.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a bivalent vaccine that has two antigens, GD2L and GD3L. The goal is to see if the patient's immune system can make antibodies against the two antigens, which would then attach to neuroblastoma cells and kill them.

Who is the study for?

This trial is for high-risk neuroblastoma patients who've had previous immunotherapy, are in first or subsequent remission, and have normal organ function tests. They must be able to follow the study plan and not have allergies to vaccine components like KLH or OPT-821.Check my eligibility

What is being tested?

The trial is testing a bivalent vaccine with two antigens linked to KLH protein, combined with an adjuvant (OPT-821) and oral β-glucan. The goal is to stimulate the immune system to produce antibodies that target neuroblastoma cells.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, allergic responses, and potentially low blood counts which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My neuroblastoma is high-risk and fits specific stage and age criteria.

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I have been diagnosed with neuroblastoma based on tissue tests or bone marrow and urine tests.

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My neuroblastoma is high-risk, stage 4 with MYCN amplification or I am over 18 months old.

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I have been diagnosed with neuroblastoma based on tissue tests or bone marrow and urine tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To assess anti-NB activity of the bivalent vaccine plus oral β-glucan in patients who are enrolled with evidence of minimal residual disease (MRD) by molecular biological testing of bone marrow. (PHASE II)

To determine the maximally tolerated dose of OPT-821 in a vaccine containing two antigens abundantly expressed on neuroblastoma. (PHASE I)

To prove the adjuvant effect of oral beta-glucan on anti-GD2 antibody titer among patients who are in first or second (or later) complete

Secondary outcome measures

To assess FcRIIa, FcRIIIa, CR3 and CD18 gene polymorphism of leukocytes (effector cells), with a view towards a possible association with outcome. (PHASE II)

To obtain data on the immune response directed against the target NB-associated antigens in patients as induced by the subcutaneous administration of the bivalent vaccine. (PHASE II)

To obtain preliminary data on the anti-neuroblastoma activity of the bivalent vaccine plus oral β-glucan in patients, including measuring the molecular response in blood and bone marrow. (PHASE I)

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: vaccine group twoExperimental Treatment2 Interventions

Group II: vaccine group threeExperimental Treatment2 Interventions

Patients will receive a total of 7 subcutaneous injections, at weeks 1, 2, 3, 8 , 20 , 32 , and 52. Minor schedule adjus tment s are permitted , as needed Vaccines must occur a minimum of 6 days apart. The last three vaccine s can be administered up to one week earlier or later than indicated without representing a protocol violation.Group 3 will include patients who have previously received vaccine and oral β glucanglucan. Patients in this group will not be randomized using the MSK CRDB system. They will be treated as patients in Group 1 and receive o ral β glucan (40 mg/kg/day) starting at week 6 or 7 and continue with approximately 2 weeks on, 2 weeks off, up to 1 cycle after the last vaccination . They will not be eligible for primary endpoint.

Group III: vaccine group oneExperimental Treatment2 Interventions

Patients will receive a total of 7 subcutaneous injections, at weeks 1, 2, 3, 8 , 20 , 32 , and 52. Minor schedule adjus tment s are permitted , as needed Vaccines must occur a inimum of 6 days apart. The last three vaccine s can be administered up to one week earlier or later than indicated without representing a protocol violation.Patients assigned to in Group 1 will receive o ral β glucan (40 mg/kg/day) starting at week 6 or 7 and continue with approximately 2 weeks on, 2 weeks off, up to 1 cycle after the last vaccination .

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,246 Total Patients Enrolled

49 Trials studying Neuroblastoma

5,417 Patients Enrolled for Neuroblastoma

Y-mAbs TherapeuticsIndustry Sponsor

25 Previous Clinical Trials

1,183 Total Patients Enrolled

12 Trials studying Neuroblastoma

818 Patients Enrolled for Neuroblastoma

Y-mAbs Therapeutics, IncUNKNOWN

3 Previous Clinical Trials

117 Total Patients Enrolled

Media Library

Bivalent Vaccine with OPT-821 Adjuvant (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT00911560 — Phase 1 & 2

Neuroblastoma Research Study Groups: vaccine group three, vaccine group two, vaccine group one

Neuroblastoma Clinical Trial 2023: Bivalent Vaccine with OPT-821 Adjuvant Highlights & Side Effects. Trial Name: NCT00911560 — Phase 1 & 2

Bivalent Vaccine with OPT-821 Adjuvant (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00911560 — Phase 1 & 2

Frequently Asked Questions

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

Is there a current recruitment process for this clinical trial?

"Unfortunately, according to the records hosted on clinicaltrials.gov this study has concluded recruitment for participants; it commenced in May 2009 and was last updated in October 2022. Nevertheless, there are still 161 other trials actively seeking out candidates at present."

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Recent research and studies

Clinical Cancer ResearchJournal

Phase I Trial of a Bivalent Gangliosides Vaccine in Combination with Β-glucan for High-risk Neuroblastoma in Second or Later Remission

Kushner, Brian H., Irene Y. Cheung, Shakeel Modak, Kim Kramer, Govind Ragupathi, and Nai-Kong V. Cheung. 2014. “Phase I Trial of a Bivalent Gangliosides Vaccine in Combination with Β-glucan for High-risk Neuroblastoma in Second or Later Remission”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-13-1012.

Journal of Clinical OncologyJournal

Survival Impact of Anti-gd2 Antibody Response in a Phase II Ganglioside Vaccine Trial Among Patients with High-risk Neuroblastoma with Prior Disease Progression

Cheung, Irene Y., Nai-Kong V. Cheung, Shakeel Modak, Audrey Mauguen, Yi Feng, Ellen Basu, Stephen S. Roberts, Govind Ragupathi, and Brian H. Kushner. 2021. “Survival Impact of Anti-gd2 Antibody Response in a Phase II Ganglioside Vaccine Trial Among Patients with High-risk Neuroblastoma with Prior Disease Progression”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.01892.

clinicaltrials.govStudy

Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma

2009. "Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00911560.

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