Irinotecan Plus Lenalidomide in Adult Patients With Recurrent Glioblastoma Multiforme (Phase II)
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|ClinicalTrials.gov Identifier: NCT02369367|
Recruitment Status : Withdrawn (Original study did not progress to Phase 2.)
First Posted : February 23, 2015
Last Update Posted : February 25, 2015
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.
This record represents the Phase II portion of original Phase I/II study (see registration record NCT00671801).
|Condition or disease||Intervention/treatment||Phase|
|Malignant Gliomas||Drug: Irinotecan Drug: Lenalidomide||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Irinotecan Plus Lenalidomide in Adult Patients With Recurrent Glioblastoma Multiforme|
|Study Start Date :||April 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.
- 6-month progression-free survival (PFS6) [ Time Frame: 6 months (26 weeks) ]Number of participants alive and free from progression (no disease progression) at 6 months following treatment. A combination of the neurological examination and MRI brain scan will be used to define overall response or progression. Participants who complete at least 4 weeks of treatment will be eligible for evaluation of PFS6.
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): NCT02369367
|Principal Investigator:||John DeGroot, MD||M.D. Anderson Cancer Center|