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
This trial does not accept healthy volunteersQualifiers
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. For those patients with a positive site of disease that is poorly visualized on a scan, it can be per PI discretion to repeat the scan or proceed with enrollment without a recent scan.
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.
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
Design model
Parallel
Treatments tested in this trial
OPT-821 (QS-21)
Biological/VaccineComprised of the immunological adjuvant OPT-821 (QS-21)
oral β-glucan
Dietary supplementParticipants will be randomized to receive this agent in two different schedules
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Group 1Experimental treatment 2 interventions
Group B: Group 2Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Mean antibody titer in ng/ml of anti-GD2 IgG1 titer
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.
Time frame
up to 32 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov