Irinotecan Plus Lenalidomide in Adult Patients With Recurrent Glioblastoma Multiforme: Phase I
The goal of this clinical research study is to find the highest tolerable dose of lenalidomide combined with Camptosar (irinotecan) as well as to see if this drug combination can help control malignant gliomas.
Researchers will also study if a special magnetic resonance imaging (MRI) technique (dynamic MRI scan) is useful in looking at the effect of treatment on the tumor. Another goal is to learn the effect of lenalidomide on tumor tissue in patients who need surgery for the disease.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Irinotecan Plus Lenalidomide in Adult Patients With Recurrent Glioblastoma Multiforme|
- Maximum Tolerated Dose (MTD) of Lenalidomide and Irinotecan [ Time Frame: First cycle (28 days) ] [ Designated as safety issue: Yes ]MTD declared dose level if </= 1 dose limiting toxicity (DLT) occurs.
|Study Start Date:||April 2008|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Irinotecan + Lenalidomide
Irinotecan 200 mg/m^2 intravenous once every 2 weeks on days 1 and 15; Lenalidomide orally 7.5 mg/day on Cycle 1 Days 1-21 and 10 mg/day on Cycle 2 Days 1-21.
200 mg/m^2 by vein over 90 minutes once every 2 weeks on days 1 and 15.
Other Names:Drug: Lenalidomide
Given orally at escalating doses beginning 7.5 mg/day on Cycle 1 Days 1-21 and 10 mg/day on Cycle 2 Days 1-21.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00671801
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||John DeGroot, MD||M.D. Anderson Cancer Center|