Study on Bivalent Vaccine with OPT-821 and Oral β-glucan for High-Risk Neuroblastoma

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT00911560

Provider View

This clinical trial is testing a vaccine combined with an oral supplement to see if it can help the immune system fight high-risk neuroblastoma, a type of cancer. The study aims to determine the effects of the vaccine when given at a consistent dose to all patients.

Patient Parameters

Program Overview

In this study, researchers are testing a vaccine designed to help the immune system fight neuroblastoma, a type of cancer. The vaccine contains two proteins, GD2L and GD3L, which are found on neuroblastoma cells. The goal is for the vaccine to help the body produce antibodies that can attach to these proteins on cancer cells, allowing white blood cells to attack and kill the cancer. The study also uses β-glucan, a sugar from yeast taken by mouth, to help white blood cells work better. The vaccine is mixed with a protein called KLH and a substance called OPT-821 to enhance its effectiveness.

Description

In this phase II study, patients who are in their first or later remission from neuroblastoma will receive the vaccine at a fixed dose. The vaccine is given along with OPT-821, a substance that helps boost the immune response. Patients will be randomly assigned to start taking oral β-glucan either in the first week or the sixth week of the study. The study aims to see how well this combination works in helping the immune system fight neuroblastoma.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with neuroblastoma, confirmed by specific medical tests.
  • Classified as high-risk neuroblastoma based on certain medical guidelines.
  • In first complete remission for at least 6 months after starting immunotherapy, or in second or later remission.
  • Have a certain level of white blood cells and neutrophils.
  • Have manageable side effects from previous treatments, as determined by medical tests.
  • Liver enzymes within specified limits.
  • Allowed to have had previous immunotherapy treatments.
  • Must have completed previous cancer treatments at least 3 weeks but no more than 6 months before starting the vaccine.
  • Can participate again if previously enrolled, but will be placed in the control group.
  • Must sign a consent form acknowledging understanding of the study's experimental nature.

Exclusion Criteria

  • Allergic to any components of the vaccine or β-glucan.
  • Have a life-threatening infection.
  • Unable to follow the study requirements.

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