The wafers are placed after the surgical resection of the tumor
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Gliadel

The GLIADEL® Wafer is a small wafer that contains the chemotherapeutic drug carmustine, or BCNU. After a specific brain tumor called a high-grade malignant glioma is surgically removed, up to 8 GLIADEL® Wafers are implanted in the cavity the tumor once occupied, slowly delivering BCNU directly to the tumor site. Find out more about GLIADEL® Wafer.
GLIADEL® is marketed by MGI® pharma more...

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GLIADEL® Wafer is indicated in newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. GLIADEL® Wafer is also indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery.

The technology of the biocompatible and biodegradable polymer that constitutes the "body" of the wafer was developed by the MIT (Massachussets Institute of Thecnology).

GLIADEL® Wafer and survival

A recent clinical study was conducted in 240 men and women undergoing initial surgery for a newly diagnosed high-grade malignant glioma. Each patient was randomly assigned to receive either surgery with implantation of GLIADEL® Wafer followed by radiation therapy, or surgery with implantation of placebo wafers (wafers without any BCNU) followed by radiation therapy.

The results in this study showed that survival was significantly prolonged in the patients who received GLIADEL® Wafer compared to those who received the placebo wafers: median survival—the length of time half of the patients in the study survived—increased to 13.9 months from 11.6 months.

Patients undergoing craniotomy and implantation of GLIADEL® Wafer for malignant glioma should be monitored closely for complications of craniotomy. During a randomized trial of GLIADEL® Wafer vs placebo implanted during initial resection, five categories of adverse events occurred that are possibly treatment-related: seizure (33.3% vs 37.5%); brain edema (22.5% vs 19.2%); healing abnormalities (15.8% vs 11.7%) including cerebrospinal fluid (CSF) leaks (5.0% vs 0.8%); intracranial hypertension (9.0% vs 2.0%); and intracranial infection (5.0% vs 6.0%). During a randomized trial of GLIADEL® Wafer vs placebo for recurrent disease, five categories of adverse events occurred that are possibly treatment-related: post-operative seizure (19.0% vs 19.0%); healing abnormalities (14.0% vs 5.0%); intracranial hypertension (4.0% vs 6.0%); brain edema (4.0% vs 1.0%); and intracranial infection (4.0% vs 1.0%).

Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL® Wafer, including one case leading to brain herniation. GLIADEL® Wafer contains carmustine and should not be given to patients who are allergic to carmustine. There are no studies assessing the reproductive toxicity of GLIADEL® Wafer. Carmustine can also cause fetal harm when administered to a pregnant woman.

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New brain cancer treatment - Guilford Pharmaceuticals Inc. receives approval to use gliadel wafers to deliver drugs to treat glioblastoma multiforme cancer
From FDA Consumer, 12/1/96

A recently approved implantable wafer is the first technology to deliver an anticancer drug directly to the site of a surgically removed brain tumor in recurrent brain cancer.

Gliadel wafers were approved by FDA on Sept. 24 to treat glioblastoma multiforme, an aggressive type of brain cancer in the malignant glioma class of cancers. Glioblastoma multiforme, which occurs mainly in adults, has been extremely difficult to treat effectively with cancer therapies such as surgery, radiation, and traditional chemotherapy.

Implanted into the cavity of the brain created when a tumor is removed, the wafers--seven or eight of them, depending on the cavity's size--deliver the anticancer drug BiCNU (carmustine) directly to the affected area of the brain. The direct delivery lessens the exposure of the rest of the body to the drug.

In a study of 222 patients with recurrent malignant glioma who had been initially treated with surgery and radiation, the six-month survival rate in those with glioblastoma multiforme who received Gliadel was 56 percent, compared with 36 percent for those who received a placebo. In patients with diagnoses other than glioblastoma multiforme, Gliadel did not affect survival rates. A small 32-patient study supported these results.

Patients should be monitored closely after implantation for possible complications such as seizures, infections, abnormal wound healing, and brain swelling. Approval followed a June 15, 1996, recommendation for approval by FDA's Oncologic Drug Advisory Committee. Since October 1995, Gliadel had been available under a Treatment IND to patients with recurrent malignant glioma.

Gliadel is manufactured by Guilford Pharmaceuticals Inc., of Baltimore.

COPYRIGHT 1996 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group

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