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A Study of a Vaccine in Combination with Beta-glucan in People with Neuroblastoma
Trial Status: active
This phase II trial tests the effectiveness of bivalent vaccine, saponin-based immunoadjuvant OBI-821 (OPT-821 [QS-21]), in combination with beta-glucan in treating patients with neuroblastoma that has a higher chance of coming back or resisting standard treatment (high-risk). A bivalent vaccine, such as OPT-821 (QS-21), works by stimulating an immune response against two different antigens, which are specific proteins on the surface of a cell. OPT-821 (QS-21) stimulates an immune response against GD2L and GD3L that are found on neuroblastoma cells and trains the immune system to make antibodies against them. Beta-glucan is a kind of sugar from yeast and may help white blood cells kill tumor cells. Giving OPT-21 (QS-21) vaccine in combination with beta-glucan may kill more tumor cells in patients with high-risk neuroblastoma.
Inclusion Criteria
Diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed by the Memorial Sloan Kettering [MSK] Department of Pathology) or bone marrow (BM) metastases plus high urine catecholamine levels, or positivity in MIBG scan
HR-NB as defined by risk-related treatment guidelines and international criteria, 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 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 fludeoxyglucose F 18 (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 United States of America (USA) (Common Toxicity Criteria for Adverse Events [CTCAE] version [v]5.0) 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
Additional locations may be listed on ClinicalTrials.gov for NCT06057948.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Brian Harris Kushner
Phone: 212-639-6793
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Brian Harris Kushner
Phone: 212-639-6793
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Brian Harris Kushner
Phone: 212-639-6793
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Brian Harris Kushner
Phone: 212-639-6793
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Brian Harris Kushner
Phone: 212-639-6793
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Brian Harris Kushner
Phone: 212-639-6793
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Brian Harris Kushner
Phone: 212-639-6793
PRIMARY OBJECTIVE:
I. To determine the effect of oral beta-glucan schedule on anti-GD2 antibody titers among patients who are in first or second (or later) complete response (CR), i.e., have no evidence of neuroblastoma (NB) by standard studies.
SECONDARY OBJECTIVES:
I. To assess the impact of schedules of beta-glucan on event-free survival (EFS) and overall survival (OS) of patients with high-risk (HR)-NB in first or subsequent CR.
II. To evaluate anti-GD2, anti-GD3 and anti-KLH antibody responses associated with vaccine plus two different schedules of beta-glucan.
III. To assess the safety of vaccine plus two different schedules of beta-glucan.
IV. To characterize leukocyte polymorphisms (including C-type lectin single nucleotide polymorphism) and a possible association with outcome or antibody titers.
EXPLORATORY OBJECTIVES:
I. To assess the utility of monitoring of minimal residual disease (MRD) using circulating cell-free deoxyribonucleic acid (cfDNA) and exosome analysis.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients receive OPT-821 (QS-21) subcutaneously (SC) on weeks 1, 2, 3, 8, 20, 32, 52, 78, 104, and 156. Patients also receive beta-glucan orally (PO) once daily (QD) for 14 days and then rest for 14 days until vaccination 5 (weeks 1-20). Patients then receive beta-glucan PO QD for 14 days after vaccinations 6-10 (during weeks 32, 52, 78, 104, and 156). Additionally, patients undergo bone marrow aspiration and biopsy during screening and blood sample collections, computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, meta-iodobenzylguanidine (MIBG) scans and/or positron emission tomography (PET) scans throughout study.
GROUP 2: Patients receive OPT-821 (QS-21) subcutaneously SC on weeks 1, 2, 3, 8, 20, 32, 52, 78, 104, and 156. Patients also receive beta-glucan PO QD 14 days and then rest for 14 days until vaccination 7 (weeks 1-52). Patients then receive beta-glucan PO QD for 14 days after vaccinations 8-10 (during weeks 32, 78, 104 and 156). Additionally, patients undergo bone marrow aspiration and biopsy during screening and blood sample collections, bone marrow aspiration and biopsy, CT scans, MRI scans, MIBG scans and/or PET scans throughout study.
After completion of study treatment, patients are followed up periodically for 5 years.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
