Actively Recruiting
Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821, Combined With Oral Beta-Glucan and Randomized GM-CSF, for High-risk Neuroblastoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-07
286
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a combination treatment involving a bivalent vaccine, beta-glucan (a sugar), and granulocyte-macrophage colony stimulating factor (GM-CSF) in people with high-risk neuroblastoma who are in complete remission. This Phase II trial aims to evaluate how these components might work together to strengthen the immune system's response against cancer cells. The study is sponsored by Memorial Sloan Kettering Cancer Center and involves randomizing participants to different treatment groups. Participants are assigned to one of three groups. Group 1 receives oral beta-glucan starting at week 1 and annual booster vaccinations without GM-CSF. Group 2 receives oral beta-glucan plus GM-CSF given in cycles aligned with vaccine doses at specified weeks. Group 3 includes participants who cannot be randomized or who have been previously treated; they receive the same treatment as Group 1 but with some variations in vaccination schedules. The vaccine injections are spaced at least 6 days apart, with some flexibility after the initial doses. During the study, participants will receive regular oral beta-glucan doses and vaccine injections over several years, including booster vaccinations up to five years after starting. Researchers will monitor immune response by measuring anti-GD2 antibody levels at 32 weeks and track safety through clinical evaluations and laboratory tests. The study includes close monitoring for side effects and continues long-term follow-up to assess immune response durability and overall participant health.
CONDITIONS
Brief Title
A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of neuroblastoma (NB) confirmed by pathology or bone marrow metastases plus specific tests
- High-risk NB as defined by international criteria including disease stage and genetic markers
- In first complete remission for at least 6 months after starting immunotherapy or in second/subsequent complete remission
- Grade 3 or less toxicities related to blood, heart, nerve, lung, kidney, liver, or digestive function
- Adequate blood counts: ANC 6 500/mcl, lymphocytes 6 500/mcl, hemoglobin 8 g/dL, platelets 50,000/mm3
- Kidney function within limits (serum creatinine 4.5 times upper normal limit or eGFR >60)
- Liver function within limits (bilirubin 3 times upper normal limit, AST and ALT 5 times upper normal limit)
- Completed prior immunotherapy or investigational therapy with sufficient time before first vaccination
- 21 to 180 days between finishing systemic therapy and first vaccination
- Recovery from any prior severe toxicities
- Previous participants who did not complete vaccinations may enroll in Group 3
- Negative pregnancy test if of child-bearing potential
- Signed informed consent acknowledging investigational nature of the program
You will not qualify if you...
- Significant severe (grade >4) toxicity in blood, heart, nerve, lung, kidney, liver, or digestive function
- History of allergy to KLH, QS-21, OPT-821, glucan, or GM-CSF
- Active life-threatening infection needing systemic treatment
- Inability to follow study requirements
- Allergy to GM-CSF or inability to obtain GM-CSF due to insurance issues
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 156 weeks (3 years) with annual booster vaccinations continuing through 5 years
Participants receive a series of vaccine injections combined with oral β-glucan and, depending on group assignment, GM-CSF. Vaccinations occur at weeks 8, 20, 32, 52, 78, 104, and 156, with β-glucan administered in cycles of approximately 2 weeks on and 2 weeks off. GM-CSF dosing varies by group and vaccination number.
Multiple vaccination visits over 3 years with additional annual booster visits up to 5 years
Trial Site Locations
Total: 1 location
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
B
Brian Kushner, MD
F
Fiorella Iglesias Cardenas, MD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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