Glioblastoma Clinical Trial
Official title:
Phase I Study of Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Recurrent or Progressive Malignant Gliomas
This is a single center Phase I study to determine the safety and maximum tolerated dose
(MTD) of autologous dendritic cells (DCs) loaded with allogeneic brain tumor stem cells
administered as a vaccination in children and adults with recurrent brain tumors. Once the
MTD has been determined, we will conduct a phase II study to determine efficacy.
Clinical trials that utilize DCs for immunotherapy have demonstrated significant survival
benefit for patients who exhibit robust immune responses against tumor cells. Unfortunately,
at the present time the majority of tumor patients are unable to mount an adequate immune
response and thus succumb to their tumors. We postulate that the inability to generate an
appropriate immune response in these patients is due to a lack of sufficient numbers of
appropriate T cells due to an inadequate source of tumor antigens.
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.
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