Actively Recruiting
A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-02
94
Participants Needed
7
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to test which treatment schedule of β-glucan with bivalent vaccine is more effective for participants with high-risk neuroblastoma that is in complete remission.
CONDITIONS
Official 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 international criteria
- High-risk neuroblastoma as defined by metastatic/non-localized disease with MYCN amplification, disease resistant to standard chemotherapy, or specific age and disease characteristics
- First complete remission at least 6 months after starting anti-GD2 antibody immunotherapy, or second or later complete remission after treatment for progression
- Grade 3 or lower toxicities related to blood, heart, nervous system, lungs, kidneys, liver, or gastrointestinal function
- Absolute neutrophil count (ANC) of 500/mcl or higher
- Absolute lymphocyte count of 500/mcl or higher
- Between 21 and 180 days since finishing systemic therapy before first vaccination
- Negative pregnancy test if able to bear children
- Signed informed consent acknowledging investigational treatment
You will not qualify if you...
- Grade 4 toxicities in blood, heart, nervous system, lungs, kidneys, liver, or gastrointestinal function
- Allergy to KLH, QS-21, OPT-821, or glucan
- Previous treatment with this vaccine
- Active life-threatening infection needing systemic treatment
- Unable to follow study protocol requirements
AI-Screening
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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
CONTACT
F
Fiorella Iglasias Cardenas, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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