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Gliadel wafer

External Beam Radiation Therapy

Allen K Sills, MD

The purpose of this study is to determine the safety and efficacy of the combination of Gliadel wafers plus surgery and limited field radiation therapy with concomitant temozolomide followed by temozolomide given at an extended dose schedule (metronomic schedule) in patients undergoing initial surgery for newly-diagnosed high grade glioma.

The patient population in this Phase II clinical trial will be patients with newly diagnosed high-grade glioma undergoing initial surgery. Patients will receive Surgery + Gliadel® wafer implantation + Limited Field Radiation Therapy with concomitant daily temozolomide (75 mg/m2) followed by monthly temozolomide given at the same dose (75 mg/m2 per day for 21 days each month.

Patients will have up to 8 wafers implanted into the tumor resection cavity (depending upon its size) after maximal tumor resection. Between Study Days 14 and 45 all patients will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin. Temozolomide will be administered concomitantly with radiation at a daily dose of 75 mg/m2 daily (7 days/week) and then beginning no later than 30 days following completion of radiation therapy on a 75 mg/m2 daily dose given 21 days out of each month for a total of up to 18 cycles.

Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM

A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed by Metronomic Therapy With Temozolomide for Newly Diagnosed Malignant High Grade Glioma

Methodist Healthcare

Allen Sills, MD

Gliadel Wafer

Limited field radiation

Renato V. LaRocca, MD

To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide

A phase II study of radiation with concomitant and then sequential Temozolomide in patients with newly diagnosed supratentorial malignant glioma who have undergone surgery with Gliadel wafer insertion. To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomitant Temozolomide followed by Temozolomide alone in patients undergoing initial surgery for newly diagnosed unifocal moderate to high grade glioma.

Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

A Phase II Study of Radiation With Concomitant and Then Sequential Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma Who Have Undergone Surgery With Gliadel Wafer Insertion

Eisai Inc.

Kentuckiana Cancer Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM	NCT00548938	Glioblastoma Mu... High-Grade Glio...	Gliadel wafer Temozolomide External Beam R...	18 Years - 72 Years	Methodist Healthcare
Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma	NCT00283543	Newly Diagnosed...	Gliadel Wafer Temozolomide Limited field r...	18 Years - 72 Years	Kentuckiana Cancer Institute
Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma	NCT00283543	Newly Diagnosed...	Gliadel Wafer Temozolomide Limited field r...	18 Years - 72 Years	Kentuckiana Cancer Institute

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