RECRUITING

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

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Conditions

NeuroblastomaHigh-risk NeuroblastomaMetastatic NeuroblastomaHR-NBMemorial Sloan Kettering Cancer Center23-198

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821 (QS-21), in Combination With Randomization of Oral β-glucan, for High-Risk Neuroblastoma

Quick Facts

Study Start:2023-09-21
Study Completion:2026-03-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06057948

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * 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.
  4. * 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:
  5. * Absolute neutrophil count (ANC) ≥ 500/mcl
  6. * Absolute lymphocyte count ≥ 500/mcl
  7. * \>21 and \<180 days between completion of systemic therapy and 1st vaccination.
  8. * A negative pregnancy test is required for patients with child-bearing capability
  9. * Signed informed consent indicating awareness of the investigational nature of this program.
  1. * 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.
  2. * History of allergy to KLH, QS-21, OPT-821, or glucan
  3. * Prior treatment with this vaccine.
  4. * Active life-threatening infection requiring systemic therapy.
  5. * Inability to comply with protocol requirements.

Contacts and Locations

Study Contact

Brian Kushner, MD
CONTACT
1-833-MSK-KIDS
kushnerb@MSKCC.ORG
Fiorella Iglasias Cardenas, MD, MS
CONTACT
1-833-MSK-KIDS
iglesiaf@mskcc.org

Principal Investigator

Brian Kushner, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk-Commack (Consent only)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Brian Kushner, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-21
Study Completion Date2026-03-21

Study Record Updates

Study Start Date2023-09-21
Study Completion Date2026-03-21

Terms related to this study

Keywords Provided by Researchers

  • Neuroblastoma
  • High-risk Neuroblastoma
  • Metastatic Neuroblastoma
  • HR-NB
  • Memorial Sloan Kettering Cancer Center
  • 23-198

Additional Relevant MeSH Terms

  • Neuroblastoma
  • High-risk Neuroblastoma
  • Metastatic Neuroblastoma