Surgical Resection With Gliadel Wafer Followed by Dendritic Cells Vaccination for Malignant Glioma Patients

Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis
carries with it a median survival of approximately 12 months, with 90 - 95% of patients
surviving less than 2 years. The current standard treatment of surgical resection followed
by radiation therapy and chemotherapy has not substabntially prolonged survival and even the
few treatment options shown to exhibit small increases in survival primarily benefit certain
( i.e., young ) patient subpopulations.

Cancer vaccines represent one novel therapy for malignant gliomas. The goal is for the body
to recognize the tumor cells as foreign and produce its own response to fight off recurring
tumor cells. A promising means of causing an immune response so the body can create this
immunity is through the use of dendritic cell ( DC ) vaccines.

Dendritic cells are a small group of cells contained in everyone's white blood cell
population. These cells are responsible for letting the immune system know that something
foreign, like bacteria, or a tumor, is in the body. Dendritic cells help the body ward off
disease by alerting the immune system.

gliadel is an FDA - approved drug - a wafer containing a concentrated amount of a
chemotherapy agent. These wafers are placed into the brain cavity after the tumor is
resected ( removed ) and deliver a steady amount of immediate chemotherapy medicine to the
surrounding brain tissue. Also, since Gliadel is a local chemotherapy, it will prevent the
detrimental suppression ( weakening ) of the immune system shown with systemic ( throughout
the body ) chemotherapy.

In prior Phase l and phase ll studies, patients who received chemotherapy following
Dendritic cells demonstrated longer progression free and overall survival than the patients
who received Dendritic cells or chemotherapy alone.

The purpose of this study is to determine whether after standard therapy of tumor resection
surgery, along with placement of Gliadel wafers at time of surgery followed by dendritic
cell vaccines will not only generate ( start ) an immune response, but will provide longer
progression free survival.

Patients who were screened and not enrolled in this clinical trial due to screen failure
will be notified of the reason for screen failure. Pre HIV counselling and appropriate
referral resources will be provided. If the screen failure is due to the positive HIV test,
appropriate post HIV counselling will be provided and appropriate referrals will be made.
The charts of the patients with screen failures will be destroyed.The patients charts who
will be enrolled in the study kept in the locked cabinet in the research office. patients
will be assigned a unique identifying code known only to the research team. Data will be
captured by various source documents, or, as necessary, abstracted from hospital medical
records by an experienced registered nurse. The electronic data for viral etsting will be
accessible to research personnel only.