Phase II Study of Temozolomide in Newly Diagnosed Glioblastoma

Summary

A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Following surgical resection, and confirmation of glioblastoma, patients will proceed to primary chemotherapy with temozolomide (temodar). Temodar is given for 42 consecutive days on and 14 days off occurring every 56 days. Procedures prior to initial study treatment (\<14 Days) are: Neurological/Oncological History, Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast. The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment. And the off study procedures for patients are performance status, Quality Of Life FACT-BR, MGMT tissue analysis, and cranial CT/MRI with and without contrast. Patients may continue with each temodar daily dose therapy if clinical and neuroradiographical exams are stable or improving.

Timeline

Start

2006-07

Primary completion

2007-06

Completion

2007-06

Outcome

Outcome not reported

Stopped: “IRB Study Closure”

Drugs

Indications