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

Description

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

Neuroblastoma, High-risk Neuroblastoma, Metastatic Neuroblastoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Neuroblastoma
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Memorial Sloan Kettering at Basking Ridge (Consent only), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (Consent Only), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (Consent Only), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Suffolk-Commack (Consent only), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (Consent only), Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Nassau (Consent Only), Uniondale, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Brian Kushner, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2026-03-21