A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma
Neuroblastoma, High-risk Neuroblastoma, Metastatic Neuroblastoma
About this trial
This is an interventional treatment trial for Neuroblastoma focused on measuring Neuroblastoma, High-risk Neuroblastoma, Metastatic Neuroblastoma, HR-NB, Memorial Sloan Kettering Cancer Center, 23-198
Eligibility 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.
Sites / Locations
- Memorial Sloan Kettering at Basking Ridge (Consent only)Recruiting
- Memorial Sloan Kettering Monmouth (Consent Only)Recruiting
- Memorial Sloan Kettering Bergen (Consent Only)Recruiting
- Memorial Sloan Kettering Suffolk-Commack (Consent only)Recruiting
- Memorial Sloan Kettering Westchester (Consent only)Recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Nassau (Consent Only)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group 1
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 #5 (~20 weeks), then only one 14-day cycle with each of vaccinations #6-#10.
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.