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

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.

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Key information

Conditions

Neuroblastoma High-risk Neuroblastoma Metastatic Neuroblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. For those patients with a positive MIBG scan, the negative FDG-PET scan can be per PI discretion to repeat within the 45 day window period prior to enrollment.
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.

Treatment and study plan

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

Primary outcomes

Mean antibody titer in ng/ml of anti-GD2 IgG1 titer

Time frame: up to 32 weeks

To determine the effect of oral β-glucan schedule on anti-GD2 antibody titers among patients who are in first or second (or later) CR, i.e., have no evidence of neuroblastoma by standard studies.

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Kushner, MD

CONTACT

[email protected]

1-833-MSK-KIDS

Fiorella Iglasias Cardenas, MD, MS

CONTACT

[email protected]

1-833-MSK-KIDS

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Sep 28, 2023
Registry last updated: Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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