Conditions: Carcinoma, Renal Cell Kidney Neoplasms
Keywords: Advanced Renal Cell Carcinoma Kidney Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 626
Healthy volunteers: no

Brief summary:
The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 \[Temsirolimus\], administered intravenously \[IV\] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa \[IFN alfa\] subcutaneously \[SC\] three times per week \[TIW\], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Interferon Alfa intervention 2: CCI-779 intervention 3: Interferon Alfa and CCI-779
Intervention descriptions: intervention 1: Interferon alfa (Roferon) 3 MU given Sub Cutaneously three time /week for the first week, 9 MU given Sub Cutaneously three time /week for the second week, 18 MU given Sub Cutaneously three time /week thereafter. intervention 2: 25 mg of CCI-779 given Intra Venously once per week intervention 3: 15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week

Protocol document: