Sarasar and Temodar for Glioblastoma Multiforme Patients
The goal of this clinical research study is to find the highest safe dose of the new drug Sarasar (lonafarnib) that can be given together with Temodar (temozolomide) in a continuous daily dosing regimen to patients with brain tumors. The second goal is to learn if these drugs given in combination can shrink or slow the growth of brain tumors.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/Ib Study of Sarasar and Temodar in Patients With Recurrent or Temodar-Refractory Glioblastoma Multiforme|
- Maximum tolerated dose (MTD) Sarasar when combined with Temodar in an alternating week schedule [ Time Frame: 28 Day Cycle ] [ Designated as safety issue: Yes ]MTD of Sarasar given with Temodar will be that dose at which fewer than one-third of participants experience dose limiting toxicity (DLT).
- 6-month Progression-Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]Progression defined as 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Progression measured using combination of neurological examination and Magnetic Resonance Imaging (MRI) brain scan.
|Study Start Date:||December 2004|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Sarasar + Temodar
Sarasar Starting Dose: 100 mg by mouth twice a day, with water, for 7 consecutive days (Days 8-14 and Days 22-28). Cycle is 28 days.
Temodar 150 mg/m^2 by mouth once a day, after fasting one hour, for 7 consecutive days (Days 1-7 and Days 15-21). Cycle is 28 days.
Starting dose 100 mg by mouth twice a day, with water, for 7 consecutive days (days 8 through 14 and days 22 through 28). Cycle is 28 days.
Other Names:Drug: Temodar
150 mg/m^2 by mouth once a day, after fasting one hour, for 7 consecutive days (days 1 through 7 and days 15 through 21). Cycle is 28 days.
Other Name: Temozolomide
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00102648
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||John DeGroot, MD||M.D. Anderson Cancer Center|