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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.
Must not have
Active life-threatening infection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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
Select...
My neuroblastoma is high-risk and fits specific stage and age criteria.
Select...
I have been diagnosed with neuroblastoma based on tissue tests or bone marrow and urine tests.
Select...
My neuroblastoma is high-risk, stage 4 with MYCN amplification or I am over 18 months old.
Select...
I have been diagnosed with neuroblastoma based on tissue tests or bone marrow and urine tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have a severe infection that is putting my life at risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: vaccine group twoExperimental 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.Patients assigned to Group 2 will receive oral β glucan (40 mg/kg/day) starting week 1 and continue with approximately 2 weeks on, 2 weeks off, up to 1 cycle after the last vaccination .
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 .

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,964 Previous Clinical Trials
596,577 Total Patients Enrolled
50 Trials studying Neuroblastoma
5,462 Patients Enrolled for Neuroblastoma
Y-mAbs TherapeuticsIndustry Sponsor
25 Previous Clinical Trials
1,183 Total Patients Enrolled
13 Trials studying Neuroblastoma
878 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 two, vaccine group one, vaccine group three
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
~12 spots leftby May 2025
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