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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Celgene Corporation |
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00671801 |
Primary Objectives:
Phase I:
1. To determine the toxicity and maximum tolerated dose of the combination of lenalidomide and irinotecan in patients with recurrent malignant gliomas (WHO grade III and IV) not on EIAEDs (Phase I component).
Phase II:
1. To determine the efficacy of combination of lenalidomide and irinotecan in patients with recurrent and/or progressive WHO grade IV malignant glioma (GBM and gliosarcoma) not on EIAEDs as measured by the primary endpoint of 6-month progression-free survival (PFS6)
Secondary Objectives:
Condition | Intervention | Phase |
Malignant Gliomas |
Drug: Irinotecan Drug: Lenalidomide |
Phase I Phase II |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Irinotecan Irinotecan hydrochloride Lenalidomide CC 5013 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Trial of Irinotecan Plus Lenalidomide in Adult Patients With Recurrent Glioblastoma Multiforme |
Estimated Enrollment: | 51 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Irinotecan + Lenalidomide
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Drug: Irinotecan
200 mg/m^2 IV over 90 minutes once every 2 weeks on days 1 and 15.
Drug: Lenalidomide
Lenalidomide given orally at escalating doses of 10 mg/day, 15 mg/day, 20 mg/day and 25 mg/day on days 1-21.
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Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Vinay K. Puduvalli, MD | 713-792-2883 |
United States, Texas | |||||
U.T.M.D. Anderson Cancer Center | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Principal Investigator: Vinay K. Puduvalli, MD |
M.D. Anderson Cancer Center |
Celgene Corporation |
Principal Investigator: | Vinay K. Puduvalli, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Vinay K. Puduvalli, MD/Associate Professor ) |
Study ID Numbers: | 2006-0472 |
First Received: | April 30, 2008 |
Last Updated: | May 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00671801 |
Health Authority: | United States: Institutional Review Board |
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