Back to resultsGranulocyte-macrophage Colony-stimulating Factor, Interferon and Interleukin-2 as Adjuvant Treatment for Renal Cancer
Primary Purpose
Renal Cell Carcinoma
Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
GM-CSF, IFN alpha and IL-2
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Kidney Cancer, Renal cell carcinoma, High risk, Adjuvant therapy
Eligibility Criteria
Inclusion Criteria:
- completely resected advanced high-risk RCC
- T3b-c, T4, or N1-2, or M1 disease resected to no evidence of disease (AJCC-TNM, 2002) Patients must have recovered from any effects of surgery, which must have been - excellent performance status (Eastern Cooperative Oncology Group performance status of 0 or 1);
- adequate organ function defined as WBC count 4,000/µL, platelet count 100,000/µL, hemoglobin 10 g/dL, serum creatinine 1.5 mg/dL or creatinine clearance 60 mL/min, and direct bilirubin 1.5 mg/dL; and forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing
- age 18 years and older
Exclusion Criteria:
- history or evidence of cardiac disease on ECG or autoimmunity
- prior systemic treatment for RCC
- history of invasive malignancy in the past 5 years or human immunodeficiency virus positivity
- positive pregnancy test
Sites / Locations
- N.N. Blokhin Russian Cancer Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group: GM-CSF, IFN, IL-2
Arm Description
Outcomes
Primary Outcome Measures
Disease-free survival (DFS)
Secondary Outcome Measures
Progression rate
Overall survival (OS)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
NCT ID
NCT01176552
First Posted
April 13, 2010
Last Updated
August 22, 2010
Sponsor
Kidney Cancer Research Bureau
1. Study Identification
Unique Protocol Identification Number
NCT01176552
Brief Title
Granulocyte-macrophage Colony-stimulating Factor, Interferon and Interleukin-2 as Adjuvant Treatment for Renal Cancer
Official Title
Granulocyte-macrophage Colony-stimulating Factor, Interferon Alpha and Interleukin-2 as Adjuvant Treatment for High-risk Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kidney Cancer Research Bureau
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This prospective study assesses toxicity and potential efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon (IFN) alpha and interleukin-2 (IL-2) postoperatively in patients with high-risk renal cell carcinoma (RCC).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Kidney Cancer, Renal cell carcinoma, High risk, Adjuvant therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group: GM-CSF, IFN, IL-2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GM-CSF, IFN alpha and IL-2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease-free survival (DFS)
Time Frame
3.5 years
Secondary Outcome Measure Information:
Title
Progression rate
Time Frame
28 months
Title
Overall survival (OS)
Time Frame
5 years
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
completely resected advanced high-risk RCC
T3b-c, T4, or N1-2, or M1 disease resected to no evidence of disease (AJCC-TNM, 2002) Patients must have recovered from any effects of surgery, which must have been - excellent performance status (Eastern Cooperative Oncology Group performance status of 0 or 1);
adequate organ function defined as WBC count 4,000/µL, platelet count 100,000/µL, hemoglobin 10 g/dL, serum creatinine 1.5 mg/dL or creatinine clearance 60 mL/min, and direct bilirubin 1.5 mg/dL; and forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing
age 18 years and older
Exclusion Criteria:
history or evidence of cardiac disease on ECG or autoimmunity
prior systemic treatment for RCC
history of invasive malignancy in the past 5 years or human immunodeficiency virus positivity
positive pregnancy test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lev Demidov, M.D., D.Sc.
Organizational Affiliation
N.N. Blokhin Russian Cancer Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
N.N. Blokhin Russian Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Granulocyte-macrophage Colony-stimulating Factor, Interferon and Interleukin-2 as Adjuvant Treatment for Renal Cancer
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