At a glance
ClinicalIndex Comparison Record- ✓Histologically proven supratentorial glioblastoma multiforme (GBM)
- ✓Unequivocal evidence of tumor recurrence or progression by MRI or CT scan within 14 days prior to registration
- ✓Stable on steroid dose for at least 5 days before imaging; new scan required if steroids increased between imaging and registration
- ✓Prior therapy: 0 prior chemo, OR 1 adjuvant, OR 1 adjuvant + 1 recurrent, OR 1-2 recurrent/progressive regimens
- ✕Taking CYP3A4-inducing anticonvulsants (primidone, carbamazepine, phenobarbital, phenytoin)
- ✕Taking drugs that interact with ZARNESTRA/R115777: cimetidine, erythromycin, azole antifungals, paclitaxel, tacrolimus, or cyclosporine
- ✕Uncontrolled hypertension, unstable angina, symptomatic heart failure, MI within 6 months, or serious uncontrolled cardiac arrhythmia
- ✕HIV positive status
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Evaluation Temozolomide and Farnesyl Transferase Inhibitor ZARNESTRA (R115777) for the Treatment of Recurrent and Progressive Glioblastoma Multiforme
In Brief
A Phase 2 clinical trial evaluating Temozolomide and R115777 for Glioblastoma Multiforme. Completed, enrolled 55 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to find the highest safe dose of the new drug ZARNESTRA (R115777) and temozolomide that can be given to patients with brain tumors (glioblastoma multiforme, GBM). The second goal is to learn if these drugs given in combination can shrink or slow the growth of brain tumors. The safety of this treatment will also be studied.
Study Details
Timeline
Interventions
Starting Dose Level: 100 mg/m\^2 taken by mouth once daily for 7 days, followed by 7 days rest and another 7-day dosing period and 7-day rest period.
Starting Dose Level: 400 mg taken by mouth for 7 consecutive days every other week on alternating weeks (days 8-14 and 22-28) every 4 weeks.