General Information

Gliadel Wafer is an alkylating drug. This biodegradable wafer is implanted at the time of surgery and delivers chemotherapy directly to the tumor site minimizing drug exposure to other areas of the body. Gliadel Wafer complements other standard therapies for brain cancer, such as surgery, radiation and traditional intravenous chemotherapy.

Glidel Wafer is specifically indicated for newly-diagnosed high-grade glioma as an adjunct to surgery and radiation, and recurrent glioblastoma as an adjunct to surgery.

The recommended dose is eight 7.7 mg wafers (61.6 mg total dose) implanted intracranial.

Mechanism of Action

The activity of Gliadel Wafer is due to release of cytotoxic concentrations of carmustine, a DNA and RNA alkylating agent, into the tumor resection cavity. On exposure to the aqueous environment of the resection cavity, the anhydride bonds in the copolymer are hydrolyzed, releasing carmustine, carboxyphenoxypropane, and sebacic acid into the surrounding brain tissue.

Side Effects

Adverse effects associated with the use of Glidel Wafer in Newy-Diagnosed High-Grade Glioma may include, but are not limited to, the following:

• cerebral edema
• asthenia
• nausea
• vomiting
• constipation
• wound healing abnormalities
• depression

Adverse effects associated with the use of Glidel Wafer in Recurrent High-Grade Glioma may include, but are not limited to, the following:

• urinary tract infection
• wound healing abnormalities
• fever

Clinical Trial Results

In September 1996, Gliadel Wafer was cleared for marketing based on data from a landmark study involving 222 patients undergoing surgery for recurrent malignant glioma. Results from this Phase III double-blind, placebo-controlled clinical study showed that Gliadel Wafer increased survival at six months by more than 50 percent (from 36% with placebo to 56% with Gliadel Wafer) in patients with GBM.