A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Absolute neutrophil count (ANC) ≥ 500/mcl
Disqualifiers
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.
Trial design
Treatments tested in this trial
- OPT-821 (QS-21)
- oral β-glucan
Treatment groups
94 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov