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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for children and young adults with high-risk neuroblastoma, a type of cancer that can be very serious and challenging to treat. The researchers want to find out how effective a combination of a special vaccine and a substance called beta-glucan is when given to patients whose cancer is in complete remission after previous treatments. Essentially, they are testing different schedules for administering this combination to see which one works best.

To participate in this trial, patients must have a confirmed diagnosis of high-risk neuroblastoma and be in a state of complete remission for at least six months after starting immunotherapy. Other key requirements include having manageable side effects from previous treatments and being able to provide consent. Participants in the trial can expect to receive the vaccine and beta-glucan, while being closely monitored for their health and any side effects. This research is important because it could lead to better treatment options for young patients facing this challenging disease.

Gender

ALL

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.