Interleukin-2, Interferon Alpha,Capecitabine and Vinblastin for Treatment of Metastatic Renal Cell Carcinoma: A Multicenter Study
This is a phase II study, non-randomized in patients with metastatic renal cell carcinoma.
The treatment will include: Proleukin (produced by Chiron and supplied by Megapharm Israel
Ltd), Roferon A and Xeloda (produced by Roche) and VBL. The treatment will be given in
8-week courses with an interval of two weeks of rest in which the response (on D63) and
toxicity will be assessed.
45 patients with MRCC will be entered into this study during a 18-month period. All patients
must meet all inclusion and exclusion criteria. All data of each participating patient,
including medical history, disease characteristics, laboratory and imaging tests, response
and toxicity to treatment will be entered into the specific form before, during, after each
treatment course and during follow up.
Patients will be followed up for survival status and disease status every 6 months until
last visit or death.
Proleukin S.C. 10X106 IU/m2 three times a week (Sun, Tue, Thu), weeks 1 – 4 Roferon A S.C.
6 X 106 IU/m2 once a week (Wed), weeks 1 – 4 Roferon A S.C. 3 X 106 IU/m2 three times a
week, weeks 5 – 8 Xeloda Oral 1,000 mg/m2 twice a day, weeks 5, 6 Vinblastine I.V. 4mg/m2,
Day 1, weeks 5 &
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Eliahu Gez, MD
Rambam Health Care Campus
Israel: Israeli Health Ministry Pharmaceutical Administration