AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 2Ages any - anyAllMemorial Sloan Kettering Cancer Center
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

The purpose of this study is to test which treatment schedule of ฮฒ-glucan with bivalent vaccine is more effective for participants with high-risk neuroblastoma that is in complete remission.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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. 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 โ‰ฅ 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. * 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) โ‰ฅ 500/mcl * Absolute lymphocyte count โ‰ฅ 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.
๐Ÿ’Š

What it tests

  • OPT-821 (QS-21)
  • oral ฮฒ-glucan
๐Ÿ“

Where

7 sites
Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, United States
Memorial Sloan Kettering Suffolk-Commack (Consent only)
Commack, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, United States
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy