Renal Cell Carcinoma
Conditions
Keywords
Kidney Cancer, Renal cell carcinoma, High risk, Adjuvant therapy
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.
Interventions
DRUGGM-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.
Sponsors
Kidney Cancer Research Bureau
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) | 3.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression rate | 28 months |
| Overall survival (OS) | 5 years |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 12 months |
Countries
Russia
Outcome results
None listed