Phase I Study of Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Recurrent or Progressive Malignant Gliomas
Autologous DCs will be obtained from peripheral blood mononuclear cells (PBMCs) from each
patient by leukapheresis. An established BTSC line will be used as an allogeneic source of
tumor antigen. Approximately 4 weeks will be required after the leukapheresis for vaccine
production and the first vaccine administration.
Each patient will receive an injection of DCs at his/her assigned dose once every 2 weeks
during the first 8 weeks, followed by injections every 4 weeks for an additional 10
vaccinations. Imiquimod will be applied to the vaccination site just prior to and 24 hours
after each vaccine administration.
This study will use an accelerated dose escalation design (1 subject per level) until dose
limiting toxicity (DLT) is encountered, after which a traditional phase I design (3 subjects
per level) will be implemented. DLT is defined as grade 3 or greater treatment related
toxicity. A total of 6 patients will be treated at the maximum tolerated dose (MTD) or, in
the absence of DLT, at dose level 3.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
To determine the safety and maximum tolerated dose (MTD) of dendritic cells (DCs) loaded with brain tumor stem cells (BTSCs) as a source of tumor antigen for immunotherapy in children and adults with recurrent GBM, ependymoma or medulloblastoma brain tumors. Toxicity is determined using the criteria established by the National Cancer Institute's Common Terminology Criteria for Adverse Events V 4.0 (CTCAE).
4 Weeks Post Vaccination
Christopher Moertel, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|