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Gliadel

Image:Gliadel.jpg

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

GLIADELŪ Wafer is indicated in newly diagnosed high-grade malignant gliomapatients as an adjunct to surgery and radiation. GLIADELŪ Wafer is also indicated in recurrent glioblastoma multiformepatients as an adjunct to surgery.

The technology of the biocompatibleand biodegradablepolymer that constitutes the "body" of the wafer was developed by the MIT(Massachussets Institute of Thecnology).

GLIADELŪ 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 GLIADELŪ 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 GLIADELŪ 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 craniotomyand implantation of GLIADELŪ Wafer for malignant glioma should be monitored closely for complications of craniotomy. During a randomized trialof GLIADELŪ Wafer vs placeboimplanted during initial resection, five categories of adverse eventsoccurred that are possibly treatment-related: seizure(33.3% vs 37.5%); brain edema(22.5% vs 19.2%); healingabnormalities (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 GLIADELŪ 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 corticosteroidshave been described in patients treated with GLIADELŪ Wafer, including one case leading to brain herniation. GLIADELŪ Wafer contains carmustineand should not be given to patients who are allergic to carmustine. There are no studies assessing the reproductive toxicity of GLIADELŪ Wafer. Carmustine can also cause fetal harm when administered to a pregnant woman.

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es:Gliadel Implantes

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It uses material from the http://en.wikipedia.org/wiki/Gliadel Wikipedia article Gliadel.

 
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