Adenocarcinoma Clear Cell Clinical Trial
Official title:
Interleukin-2, Interferon Alpha,Capecitabine and Vinblastin for Treatment of Metastatic Renal Cell Carcinoma: A Multicenter Study
Immunochemotherapy consisting of IL-2, INF-A, and VBL and 5FU is regarded as the treatment
of choice in metastatic renal cell carcinoma. During the period 1996-2000, we evaluated the
efficacy and toxicity of this immunochemotherapy, combined with an aggressive surgical
approach: nephrectomy before treatment and resection of residual disease. The 3-year
survival rate for the entire group and complete responder patients was 30% and 88%,
respectively. The side effects were usually moderate and consisted mainly of a flu-like
syndrome, headache, nausea, vomiting and depression. Most importantly, there was no
drug-related death. Good performance status, absence of bone metastases and prior
nephrectomy were associated with higher response rates.
Capecitabine is a novel fluoropyrimidine carbamate, orally administered and selectively
activated to Fluorouracil by a sequential triple-enzyme pathway in liver and tumor cells.
Capecitabine at dose of 2,500mg/m2/d divided equally into two daily doses for 14 days in
patients who failed to respond to “standard” immunotherapy achieved a 30% objective
response. Toxicity consisted of hand-foot syndrome.
Aim of Study:
To evaluate efficacy and toxicity of the combination of IL-2, INF-A, VBL and Capecitabine in
MRCC
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.
Treatment Schedule:
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