Immunochemotherapy for Metastatic Renal Cell Carcinoma

• Status: Unknown status
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Collaborator: Roche Pharma AG
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• Inclusion Criteria; Patients with the following criteria will be included in this study

• Pathological (histology or cytology) diagnosis of renal cell carcinoma

• Clinical evidence of metastatic disease

• Performance status 0 - 2 (European Cooperative Oncology Group Score)

• Nephrectomy before starting treatment

• Normal cardiac function (left ventricular ejection fraction >45%).

• Normal blood counts: WBC >3,000/ml3, Hb >10gr%, Platelets >100,000/ml3

• Normal kidney function: Creatinine <1.3 mg/dl

• Age  18 years

• Patient's written consent (on informed consent form)

Exclusion Criteria:

• Life expectancy less than 3 months

• Brain metastases

• Ischemic heart disease - active

• Prior immunochemotherapy

• Performance status 3 or more (European Cooperative Oncology Group Score)

• Schizophrenia

• Active liver disease