A Phase I Trial of a Trivalent Vaccine with Escalating Doses of the Immunological Adjuvant OPT-821 Plus Oral ß-Glucan for High-Risk Neuroblastoma

Protocol
05-075
Full Title
Phase I/II Trial of a Bivalent Vaccine with the Immunological Adjuvant OPT-821,in Combination with Oral ß-glucan for High-Risk Neuroblastoma
Phase
I/II
Purpose

The purpose of this study is to find the highest dose of a vaccine adjuvant called OPT-821 that can be given as part of a vaccine designed to treat neuroblastoma. The vaccine in this study targets three markers on neuroblastoma cells. The aim of the vaccine is to trigger a response of the immune system against neuroblastoma by causing the patient’s body to make antibodies against these markers which would, in turn, cause white blood cells to find and attack the cancer cells.

Other substances called adjuvants are added to cancer vaccines to boost the immune response against cancer cells. OPT-821 and KLH are the two adjuvants in this vaccine. OPT-821 is another version of adjuvant QS-21 which has been used in the past but is no longer available. Investigators want to see what dose of OPT-821 can be safely given in children. Patients will also take by mouth ß-glucan, a yeast sugar that can help white blood cells kill cancer cells.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have high-risk neuroblastoma that is in second remission.
  • At least 3 weeks must have passed since completion of prior therapies and entry into the study.
  • Patients must have good immune function.
  • Patients may not have allergies to KLH, QS-21, OPT-821, or glucan.
  • Patients must be age 21 or younger.

For more information about this study and to inquire about eligibility, please contact Dr. Brian Kushner at 212-639-6793.

Disease(s)
Neuroblastoma
Locations
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