Malignant Glioma Clinical Trial
Official title:
A Phase I/II Evaluation of Vaccination With Type 1 Dendritic Cells Pulsed With Multiple Peptides in the Treatment of HLA-A2 Positive Patients With Recurrent Malignant Gliomas
This is a single-institution Phase I/II study designed to evaluate the safety and induction of an immune response, and preliminary clinical response of vaccinations with Type-1 alpha-DCs (alpha-DC1) loaded with glioma-associated antigen (GAA) epitopes and administration of poly-ICLC in patients with recurrent malignant gliomas. Approximately 30 subjects will be enrolled in this study at UPMC/UPCI Hillman Cancer Center. The study participants in this trial will be HLA-A2 positive male or female adults over 18 years of age. The primary objective is to establish the safety of this approach. The endpoints will be to determine the maximum tolerated dose (MTD) of alpha-DC1 vaccines in combination with a fixed dose of poly-ICLC, using standard criteria and close clinical followups. The secondary objectives are 1) to assess the immunological response against GAAs in patients with recurrent malignant gliomas immunized with DCs loaded with GAA-derived peptides using enzyme-linked immuno-spot (ELISPOT), delayed-type hypersensitivity (DTH) and tetramer assays; and 2) to assess the preliminary anti-tumor clinical activity of the vaccines as measured by radiological response (MRI), overall survival, and 4- and 6-month progression-free survival (PFS).
This is a single-institution Phase I/II study designed to evaluate the safety, the induction
of an immune response, and the preliminary clinical response of vaccinations with Type-1 αDCs
(αDC1) loaded with glioma-associated antigen (GAA) epitopes and administration of poly-ICLC
in patients with recurrent malignant gliomas. The hypothesis is that this form of vaccines in
combination with poly-ICLC treatment will prove to be safe, and will induce potent
anti-glioma immune responses.
The primary objective is to establish the safety of the approach.
The secondary objectives are to 1) assess the immunological response against GAAs in patients
with recurrent malignant gliomas immunized with DCs loaded with GAA-derived peptides using
enzyme-linked immuno-spot (ELISPOT), delayed-type hypersensitivity (DTH) and tetramer assays
and 2) assess the preliminary anti-tumor clinical activity of the vaccines as measured by
radiological response (MRI), overall survival, and four- and six-month progression-free
survival (PFS).
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