Gliadel® Wafer (polifeprosan 20 with carmustine implant) is indicated in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation. Gliadel is also indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery. Gliadel provides localized delivery of chemotherapy directly to the site of the tumor and is the only FDA approved brain cancer treatment capable of doing so.

Gliadel is a white, dime-sized wafer made up of a biocompatible polymer that contains the cancer chemotherapeutic drug, carmustine (BCNU). After a neurosurgeon removes a high-grade malignant glioma, up to eight wafers can be implanted in the cavity where the tumor resided. Once implanted, Gliadel slowly dissolves, releasing high concentrations of BCNU into the tumor site. The specificity of Gliadel minimizes drug exposure to other areas of the body.

Important Information About Gliadel

The following four categories of adverse events are possibly related to treatment with Gliadel during initial resection. Frequencies are listed of events that occurred in a randomized trial of Gliadel and placebo, respectively: seizure (33.3% vs 37.5%); brain edema (22.5% and 19.2%); healing abnormalities (15.8% vs 11.7%); and intracranial infection (5.0% vs 6.0%). The following three categories of adverse events are possibly related to treatment with Gliadel for recurrent disease. Frequencies are listed of events that occurred in a randomized trial of Gliadel and placebo, respectively: post-operative seizure (19% vs 19%); healing abnormalities (14% vs 5%); intracranial hypertension (4% vs 6%) and intracranial infection (4% vs 1%).

Patients undergoing craniotomy for malignant glioma and implantation of Gliadel should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema. Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with Gliadel, including one case leading to brain herniation. Gliadel contains carmustine and should not be given to patients who are allergic to carmustine. Carmustine can also cause fetal harm when administered to a pregnant woman. The short and long-term toxicity profiles of Gliadel when given in conjunction with radiation or chemotherapy have not been fully explored.

About High-Grade Malignant Gliomas

According to the American Brain Tumor Association, there are approximately 18,000 malignant gliomas diagnosed in the United States each year. Approximately 11,000-12,000 of these patients will undergo surgery to remove an original or recurrent high-grade malignant glioma. Even with aggressive conventional treatment, patients with high-grade malignant glioma typically live less than one year after diagnosis.