Immunochemotherapy for Metastatic Renal Cell Carcinoma
Status:
Unknown status
Trial end date:
2005-09-01
Target enrollment:
Participant gender:
Summary
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