Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821 (QS-21), in Combination With Randomization of Oral β-glucan, for High-Risk Neuroblastoma

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Dietary supplement, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Diagnosis of NB as defined by international criteria,102 i.e., histopathology (confirmed by the MSK Department of Pathology) or BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.

• HR-NB as defined by risk-related treatment guidelines and international criteria,102 i.e., metastatic/non-localized disease with MYCN amplification (any age), metastatic disease \>18 months old, MYCN-amplified localized disease (any age), or disease resistant to standard chemotherapy.

• HR-NB (as defined above) and in 1) first CR at ≥ 6 months from initiation of immunotherapy using anti-GD2 antibody, or 2) second or subsequent CR (achieved after treatment for PD). CR is defined according to the International Neuroblastoma Response Criteria. Patients with positive MIBG scan but negative FDG-PET scan, and CR in BM, are eligible.

• Patients with grade 3 toxicities or less using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA (CTCAE v5.0) related to hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam. Plus:

‣ Absolute neutrophil count (ANC) ≥ 500/mcl

⁃ Absolute lymphocyte count ≥ 500/mcl

• \>21 and \<180 days between completion of systemic therapy and 1st vaccination.

• A negative pregnancy test is required for patients with child-bearing capability

• Signed informed consent indicating awareness of the investigational nature of this program.

Locations
United States
New Jersey
Memorial Sloan Kettering at Basking Ridge (Consent only)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Consent Only)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Consent Only)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk-Commack (Consent only)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Consent only)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (Consent Only)
RECRUITING
Uniondale
Contact Information
Primary
Brian Kushner, MD
kushnerb@MSKCC.ORG
1-833-MSK-KIDS
Backup
Fiorella Iglasias Cardenas, MD, MS
iglesiaf@mskcc.org
1-833-MSK-KIDS
Time Frame
Start Date: 2023-09-21
Estimated Completion Date: 2026-03-21
Participants
Target number of participants: 94
Treatments
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.
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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