Saturday, February 7, 2009

Glialdel wafer for glioblastoma

Treatment Options for Glioblastoma Multiforme
The Role of GLIADEL Wafers in Glioblastoma Multiforme
GLIADEL Wafer (polifeprosan 20 with carmustine implant) is a small wafer containing the cytotoxic agent BCNU (carmustine) in a biodegradable polyanhydride copolymer. GLIADEL Wafer is a localized drug delivery system that allows high concentrations of BCNU to be delivered to the tumor cavity, thereby, overcoming the adverse side-effects associated with conventional systemic administration of BCNU.

GLIADEL Wafer is biodegradable, meaning that it dissolves slowly over time and releases high concentrations of BCNU in a sustained fashion over an extended time interval.

The GLIADEL wafers are implanted into the tumor bed following surgical removal of the brain tumor. Up to 8 GLIADEL wafers are implanted into the surgical cavity after the tumor has been removed and, as the wafers dissolve, they release high concentrations of BCNU at the tumor site to destroy residual tumor cells that have not been removed by the surgery. More than 70% of the polyanhydride copolymer degrades by three weeks after implantation although "wafer remnants" can be detected even several months after implantation.

In February 2003, the United States Food and Drug Administration (FDA) approved GLIADEL Wafer for use in newly diagnosed patients with high-grade malignant gliomas as an adjunct to surgery and radiation therapy. Prior to the FDA approval for use in newly diagnosed patients, GLIADEL Wafer was used only for those patients who suffered recurrence of glioblastoma multiforme and required a second surgery to remove the tumor.

The results of clinical trials have shown that GLIADEL Wafer significantly prolonged survival in both newly diagnosed patients and patients with recurrent glioblastoma multiforme when used as adjunctive therapy to surgery and/or radiation therapy.

The most common side-effects of GLIADEL Wafer that were observed during clinical trials included:

seizures
brain edema
wound healing problems
intracranial infections

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