Phase II Study of Temozolomide in Newly Diagnosed Glioblastoma
Status:
Terminated
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute