Irinotecan Plus Lenalidomide in Adult Patients With Recurrent Glioblastoma Multiforme: Phase I
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|ClinicalTrials.gov Identifier: NCT00671801|
Recruitment Status : Terminated (Toxicity)
First Posted : May 5, 2008
Last Update Posted : November 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Gliomas||Drug: Irinotecan Drug: Lenalidomide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Irinotecan Plus Lenalidomide in Adult Patients With Recurrent Glioblastoma Multiforme|
|Actual Study Start Date :||April 29, 2008|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
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.
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.
- Maximum Tolerated Dose (MTD) of Lenalidomide and Irinotecan [ Time Frame: First cycle (28 days) ]MTD declared dose level if </= 1 dose limiting toxicity (DLT) occurs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671801
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||John DeGroot, MD||M.D. Anderson Cancer Center|