Actively Recruiting
Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821 (QS-21) and Oral Beta-glucan for High-Risk Neuroblastoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-06-05
94
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating which treatment schedule of oral beta-glucan combined with a bivalent vaccine is more effective for people with high-risk neuroblastoma who are in complete remission. This Phase II trial includes participants diagnosed with high-risk neuroblastoma, a type of cancer that has been treated to remission, to determine the best approach to maintain remission using this combination therapy. Participants will receive the immunological adjuvant OPT-821 (QS-21) vaccine along with oral beta-glucan. There are two treatment schedules being tested: one group will take beta-glucan for 14 days on and 14 days off from the first vaccination through the fifth vaccination (about 20 weeks), then beta-glucan for 14 days with each vaccination from the sixth to the tenth. The other group will follow the same beta-glucan schedule up to the seventh vaccination (about 52 weeks) and then for 14 days with each vaccination from the eighth to the tenth. Throughout the study, researchers will measure the mean antibody level against GD2 to assess immune response up to 32 weeks. Participants will have regular vaccinations and oral medication cycles during the study period. Safety and side effects will be monitored, with assessments based on common toxicity criteria. The total study spans from the first vaccination through the tenth, with ongoing evaluations to understand which schedule is better for maintaining remission in high-risk neuroblastoma.
CONDITIONS
Brief Title
A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of neuroblastoma confirmed by pathology or bone marrow metastases plus elevated urine catecholamines or positive MIBG scan
- High-risk neuroblastoma as defined by international criteria including metastatic disease with MYCN amplification or disease resistant to standard chemotherapy
- In first complete remission at least 6 months after starting anti-GD2 immunotherapy, or in second or later complete remission
- Grade 3 or less toxicities related to organ function as per CTCAE v5.0 with adequate neutrophil and lymphocyte counts
- Between 21 and 180 days after completing systemic therapy before first vaccination
- Negative pregnancy test for patients with child-bearing potential
- Signed informed consent indicating understanding of investigational treatment
You will not qualify if you...
- Grade 4 toxicities related to organ function per CTCAE v5.0
- Allergy to KLH, QS-21, OPT-821, or beta-glucan
- Prior treatment with this vaccine
- Active life-threatening infection requiring systemic therapy
- Inability to comply with study protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 20 to 52 weeks depending on group assignment
Participants receive a bivalent vaccine combined with oral beta-glucan according to one of two schedules based on group assignment.
Vaccination visits for up to 10 vaccinations over the treatment period with oral beta-glucan cycles aligned to vaccinations
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (Consent only)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
B
Brian Kushner, MD
F
Fiorella Iglasias Cardenas, MD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here