Biochemotherapy With Temozolomide for Metastatic Melanoma
The goal of this clinical research study is to learn if treatment with Temodar (temozolomide), Velban (vinblastine), Cisplatin, Proleukin (interleukin-2), Intron-A (interferon alpha), and thalidomide can help to control melanoma that has spread to other parts of the body. The safety of this treatment will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Biochemotherapy With Temozolomide, Velban, Cisplatin, Interleukin-2, Interferon-alpha and Thalidomide for Metastatic Melanoma With Optional Intrathecal Interleukin-2 Treatment|
- Time to Progression (TTP) [ Time Frame: Following two 21 day cycles until disease progression ] [ Designated as safety issue: No ]TTP defined as the time from date of first dose of study medication to first documentation of objective tumor progression in days. Response evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) done following 2 cycles and 3 cycles.
- Number of Participants With Response [ Time Frame: Following each 21 day cycles ] [ Designated as safety issue: No ]Response evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST).
|Study Start Date:||March 2007|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Experimental: Biochemotherapy with Temozolomide
Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
250 mg/m^2 By Mouth Every 4 Hours x 3 Doses On Day 1
Other Name: TemodarDrug: Velban
1.5 mg/m^2 By Vein Over 15-30 Minutes On Days 1-4
Other Name: VinblastineDrug: Cisplatin
20 mg/m^2 By Vein Over 45-120 Minutes On Days 1-4
Other Names:Drug: Interleukin-2
9 MIU/m^2 By Vein Over 24 Hours x 4 Doses On Days 1-4
Other Names:Drug: Intron-A
5 mu/m^2 Subcutaneously (Under the skin) Daily On Days 1-5
Other Name: Interferon Alpha-2bDrug: Thalidomide
400 mg By Mouth Daily
Other Name: Thalomid
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00505635
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nicholas E. Papadopoulos, MD||M.D. Anderson Cancer Center|