Conditions: Glioblastoma Multiforme Gliosarcoma
Keywords: glioblastoma multiforme gliosarcoma malignant glioma glioma Gliadel carmustine wafers Avastin bevacizumab Temodar temozolomide Pro00025180 Desjardins Duke Preston Robert Tisch Brain Tumor Center
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and effectiveness of Gliadel wafers at the time of surgery, followed by the combination of radiation, Temodar, and Avastin, and then the combination of Avastin and Temodar, after radiation is complete, on malignant brain tumors.

About six weeks after surgery, subjects will begin standard radiation therapy, a fixed dose of Avastin every 2 weeks, and daily Temodar for the six and a half weeks of radiation. Beginning 2-3 weeks after the last radiation therapy, subjects will be given the same fixed dose of Avastin intravenously (through the vein) every 14 days. They will also be given a higher dose of oral Temodar to take daily the first 5 days of each 28-day study cycle.

Detailed description:

Arms:
arm 1: Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation

Interventions: intervention 1: Gliadel intervention 2: Radiation Therapy intervention 3: Avastin intervention 4: Temodar
Intervention descriptions: intervention 1: Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. intervention 2: At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. intervention 3: Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively.

Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. intervention 4: At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation. In addition, beginning 2-3 weeks after the last radiation therapy, but not greater than 8 weeks, patients will be treated with 5 day Temodar (200 mg/ m2).

Protocol document: