Granulocyte-macrophage Colony-stimulating Factor, Interferon and Interleukin-2 as Adjuvant Treatment for Renal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01176552|
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : August 24, 2010
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: GM-CSF, IFN alpha and IL-2||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Granulocyte-macrophage Colony-stimulating Factor, Interferon Alpha and Interleukin-2 as Adjuvant Treatment for High-risk Renal Cell Carcinoma|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||May 2010|
|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.
- Disease-free survival (DFS) [ Time Frame: 3.5 years ]
- Progression rate [ Time Frame: 28 months ]
- Overall survival (OS) [ Time Frame: 5 years ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|