A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06057948
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • OPT-821 (QS-21) — BIOLOGICAL
    Comprised of the immunological adjuvant OPT-821 (QS-21)
  • oral β-glucan — DIETARY_SUPPLEMENT
    Participants will be randomized to receive this agent in two different schedules

Study Details

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.

Key Dates

Start date
Sep 21, 2023
Status verified
Jun 2026
Primary completion
Mar 21, 2027
Completion
Mar 21, 2027

Study Design

Enrollment
94 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Participants will receive oral β-glucan (40 mg/kg/day) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #5 (\~20 weeks), then only one 14-day cycle with each of vaccinations #6-#10.
  • Experimental: Group 2
    Participants will receive oral β-glucan (40 mg/kg/day) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #7 (\~52 weeks), then only one 14-day cycle with each of vaccinations #8-#10.

Primary Outcome Measure

Mean antibody titer in ng/ml of anti-GD2 IgG1 titer [ Time Frame: up to 32 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Consent only)Basking RidgeNew Jersey07920
Brian Kushner, MD
833-675-5491
Memorial Sloan Kettering Monmouth (Consent Only)MiddletownNew Jersey07748
Brian Kushner, MD
833-675-5491
Memorial Sloan Kettering Bergen (Consent Only)MontvaleNew Jersey07645
Brian Kushner, MD
833-675-5491
Memorial Sloan Kettering Suffolk-Commack (Consent only)CommackNew York11725
Brian Kushner, MD
833-675-5491
Memorial Sloan Kettering Westchester (Consent only)HarrisonNew York10604
Brian Kushner, MD
833-675-5491
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Brian Kushner, MD
833-675-5491
Memorial Sloan Kettering Nassau (Consent Only)UniondaleNew York11553
Brian Kushner, MD
833-675-5491

Find similar trials in Basking Ridge, NJ

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Memorial Sloan Kettering at Basking Ridge (Consent only)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Consent Only)· Middletown, NJMemorial Sloan Kettering Bergen (Consent Only)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (Consent only)· Commack, NYMemorial Sloan Kettering Westchester (Consent only)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

Related Studies