Conditions: Glioblastoma Multiforme Gliosarcoma
Keywords: Glioblastoma Multiforme Gliosarcoma GBM GS Tarceva Temodar Radiation Newly Diagnosed
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 66
Healthy volunteers: no

Brief summary:
The patients eligible for this study are those diagnosed with glioblastoma or gliosarcoma who have recently undergone surgery and who have not been treated with radiation therapy or chemotherapy. This is called a phase II study. The purpose of the phase II study is to determine how effective Tarceva plus Temodar plus radiation is in controlling the growth of glioblastoma and gliosarcoma. All patients will receive radiation and Temodar plus Tarceva. There is no "placebo" drug.

Detailed description:
This is a Phase II Study of Tarceva plus Temodar during and following radiation therapy in patients with newly diagnosed glioblastoma multiforme and gliosarcoma. The efficacy and safety profile of Tarceva in combination with radiation therapy plus Temodar will be studied. In addition, correlations between response to treatment and epidermal growth factor receptor (EGFR) status as well as other molecular markers of tumor prior to treatment will be explored. Patients will be stratified according to enzyme inducing anti epileptic drug (EIAED) use. Group A (not on EIAEDs) will take 100 milligrams (mg) Tarceva/day during radiotherapy and start with a dose of 150 mg Tarceva/day two weeks after radiotherapy. Group B (on EIAEDs) will take 200mg Tarceva/day during radiotherapy and start with a dose of 300 mg Tarceva/day two weeks after radiotherapy. Both groups will take 75 mg/m\^2 Temodar/day during radiotherapy and 200 mg/m\^2 Temodar/day x 5 two weeks after radiotherapy. Intrapatient Tarceva dose escalation may occur every two weeks after radiotherapy until the appearance of a particular rash severity. The maximum dose allowed is 200 mg for group A and 500 mg for group B.

Arms:
arm 1: Single arm phase-2 experimental treatment of newly diagnosed patients with Glioblastoma with Temodar plus Tarceva plus Radiation Therapy

Interventions: intervention 1: Tarceva intervention 2: Temodar intervention 3: Radiation Therapy
Intervention descriptions: intervention 1: Tarceva (erlotinib hydrochloride; previously referred to as OSI-774), a quinazoline, is an orally active, potent, selective inhibitor of EGFR tyrosine kinase. 100 - 300 milligrams (mg) every day (QD) orally (PO) every (q) 28 days depending on EIAED Status intervention 2: Temodar 200 mg/m\^2/day x 5 days every 28 days intervention 3: Radiotherapy will be administered in 180 centigray(cGy)/day - 200cGy/day fractions delivered 5 days per week to a total dose of 5940cGy - 6100cGy. A total of 4500cGy will be delivered to the clinical tumor volume consisting of T2-bright edema + a 2centimeter margin, or, if no edema, the contrast enhancing lesion +2.5 centimeter margin. An additional boost of 1440cGy will be delivered to the gross tumor volume consisting of the contrast enhancing lesion + a 1 centimeter margin.

Protocol document: