Temozolomide, Thalidomide, and Lomustine (TTL) in Melanoma Patients
|ClinicalTrials.gov Identifier: NCT00527657|
Recruitment Status : Completed
First Posted : September 11, 2007
Last Update Posted : May 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Brain Neoplasms Melanoma||Drug: Lomustine Drug: Temozolomide Drug: Thalidomide||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Temozolomide, Thalidomide, and Lomustine (TTL) in Patients With Metastatic Melanoma in the Brain|
|Study Start Date :||February 2006|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
Experimental: Lomustine + Temozolomide + Thalidomide
Lomustine starting dose 30 mg/m^2 by mouth daily on Day 1 and 29. Temozolomide 75 mg/m^2 by mouth daily on Days 1 to 42. Thalidomide 200 mg/m^2 by mouth daily.
Starting dose 30 mg/m^2 by mouth daily on Day 1 and 29.
Other Names:Drug: Temozolomide
75 mg/m^2 by mouth daily on Days 1 to 42.
Other Name: TemodarDrug: Thalidomide
200 mg/m^2 by mouth daily.
Other Name: Thalomid
- Maximum tolerated dose (MTD) [ Time Frame: 1 cycle (8 weeks) of therapy ]
- Objective (CR+PR) response rate at the MTD [ Time Frame: 1 cycle (8 weeks) of therapy ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527657
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nicholas E. Papadopoulos, MD||M.D. Anderson Cancer Center|