RECRUITING

A Study of a Vaccine in Combination with Β-glucan and GM-CSF in People with Neuroblastoma

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Conditions

NeuroblastomaHigh-risk NeuroblastomaOPT-821QS-21β-glucanGM-CSFMemorial Sloan Kettering Cancer Center21-206

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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 the study is to explore the combination of a bivalent vaccine, a sugar called beta-glucan (β-glucan), and a protein called granulocyte-macrophage colony stimulating factor (GM-CSF) as an effective treatment for people with high-risk neuroblastoma that is in complete remission. The combination may be effective because the different parts of the treatment work to strengthen the immune system's response against cancer cells in different ways.

Official Title

Phase II Trial of a Bivalent Vaccine with the Immunological Adjuvant OPT-821 (QS-21), in Combination with Oral Β-glucan and Randomization of GM-CSF, for High-risk Neuroblastoma

Quick Facts

Study Start:2021-08-02
Study Completion:2025-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04936529

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:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed by the MSK Department of Pathology) or BM metastases plus high urine catecholamine levels.
  2. * HR-NB as defined by risk-related treatment guidelines and international criteria,i.e., metastatic/non-localized disease with MYCN amplification (any age), MYCN-non-amplified metastatic disease \>18 months old, MYCNamplified 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.
  5. * Hematologic Function
  6. * Absolute neutrophil count (ANC) ≥ 500/mcl
  7. * Absolute lymphocyte count ≥ 500/mcl
  8. * Hemaglobin (Hgb) ≥ 8 g/dL
  9. * Platelet count ≥ 50,000 mm\^3
  10. * Renal Function o Serum creatinine ≤ 3.0 x ULN
  11. * eGFR \>60 mL/min/1.73 m\^2
  12. * Serum bilirubin ≤ 3.0 × ULN
  13. * Aspartate transaminase (AST) ≤ 5.0 × ULN
  14. * Alanine aminotransferase (ALT) ≤ 5.0 × ULN
  15. * Prior treatment with other immunotherapy, including mAbs or vaccine, is allowed but must be completed ≥ 21 days before the 1st vaccination.
  16. * ≥ 21 and ≤ 180 days between completion of systemic therapy and 1st vaccination.
  17. * Patients have recovered from any toxicities grade 3 or higher caused by prior therapies.
  18. * Patients previously enrolled on this trial are eligible for repeat enrollment if they did not complete all vaccine injections during the first time on protocol but they will be assigned to Group 3 and will not be included in the primary biostatistical analyses.
  19. * A negative pregnancy test is required for patients w ith child-bearing capability.
  20. * Signed informed consent indicating awareness of the investigational nature of this program.
  1. * Patients w ith significant (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 (CTCAE v5.0)
  2. * History of allergy to KLH, QS-21, OPT-821, or glucan.
  3. * Active life-threatening infection requiring systemic therapy.
  4. * Inability to comply with protocol requirements.
  5. * Patients with history of allergy to GM-CSF or who are unable to obtain GM-CSF because of insurance issues are ineligible

Contacts and Locations

Study Contact

Brian Kushner, MD
CONTACT
1-833-675-5437
kushnerb@mskcc.org
Fiorella Iglesias Cardenas, MD, MS
CONTACT
1-833-675-5437

Principal Investigator

Brian Kushner, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
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 Date2021-08-02
Study Completion Date2025-06-15

Study Record Updates

Study Start Date2021-08-02
Study Completion Date2025-06-15

Terms related to this study

Keywords Provided by Researchers

  • Neuroblastoma
  • High-risk Neuroblastoma
  • OPT-821
  • QS-21
  • β-glucan
  • GM-CSF
  • Memorial Sloan Kettering Cancer Center
  • 21-206

Additional Relevant MeSH Terms

  • Neuroblastoma