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NCT06057948 | RECRUITING | Neuroblastoma

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

Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease

Neuroblastoma

High-risk Neuroblastoma

Metastatic Neuroblastoma

Intervention/treatment

OPT-821 (QS-21)

oral β-glucan

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 94 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-09-21
Estimated Primary Completion Date : 2026-03-21
Estimated Study Completion Date : 2026-03-21

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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.
    Exclusion Criteria
    • * Patients with grade 4 hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam, using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA.
    • * History of allergy to KLH, QS-21, OPT-821, or glucan
    • * Prior treatment with this vaccine.
    • * Active life-threatening infection requiring systemic therapy.
    • * Inability to comply with protocol requirements.
A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma

Location Details

NCT06057948

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering at Basking Ridge (Consent only)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Suffolk-Commack (Consent only)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, United States, 11553