Granulocyte-macrophage Colony-stimulating Factor, Interferon and Interleukin-2 as Adjuvant Treatment for Renal Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Granulocyte-macrophage Colony-stimulating Factor, Interferon Alpha and Interleukin-2 as Adjuvant Treatment for High-risk Renal Cell Carcinoma|
- Disease-free survival (DFS) [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
- Progression rate [ Time Frame: 28 months ] [ Designated as safety issue: No ]
- Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2004|
|Study Completion Date:||May 2010|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
|Experimental: Study group: GM-CSF, IFN, IL-2||
Drug: GM-CSF, IFN alpha and IL-2
Treatment during 6 months: GM-CSF, 1 mcg/kg, 3 times per week, subcutaneously, first week of each month; IFN, 10 MIU, 3 times per week, subcutaneously, second week, and IL-2, 1 MIU, 3 tiw, intravenously, third week. Fourth week of each month was free from treatment.
Patients with high-risk RCC have a dismal prognosis. To date, no effective adjuvant therapy exists for this patients category. We suggest that combination of granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon alpha (IFN) and interleukin-2 (IL-2) stimulate immune system from dendritic cells till cytotoxic T-lymphocytes step by step and eliminate residuary tumor cells.
This prospective, non-randomized, phase II trial assessed low-dose GM-CSF, IFN and IL-2 postoperatively in patients with high-risk renal cell carcinoma.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176552
|N.N. Blokhin Russian Cancer Research Center|
|Moscow, Russian Federation, 115478|
|Principal Investigator:||Lev Demidov, M.D., D.Sc.||N.N. Blokhin Russian Cancer Research Center|