Status:
COMPLETED
Granulocyte-macrophage Colony-stimulating Factor, Interferon and Interleukin-2 as Adjuvant Treatment for Renal Cancer
Lead Sponsor:
Kidney Cancer Research Bureau
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 patient...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01176552
Start Date
May 1 2004
End Date
May 1 2010
Last Update
August 24 2010
Active Locations (1)
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1
N.N. Blokhin Russian Cancer Research Center
Moscow, Russia, 115478