Status:
UNKNOWN
Immunochemotherapy for Metastatic Renal Cell Carcinoma
Lead Sponsor:
Rambam Health Care Campus
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Adenocarcinoma Clear Cell
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 toxi...
Detailed Description
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 an...
Eligibility Criteria
Inclusion
- \- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00226798
Start Date
December 1 2003
End Date
September 1 2005
Last Update
January 4 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rambam medical Center
Haifa, Israel