Immunochemotherapy for Metastatic Renal Cell Carcinoma
|ClinicalTrials.gov Identifier: NCT00226798|
Recruitment Status : Unknown
Verified September 2005 by Rambam Health Care Campus.
Recruitment status was: Recruiting
First Posted : September 27, 2005
Last Update Posted : January 4, 2006
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
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma Clear Cell||Drug: Capecitabine (Xeloda)||Phase 2|
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 &
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interleukin-2, Interferon Alpha,Capecitabine and Vinblastin for Treatment of Metastatic Renal Cell Carcinoma: A Multicenter Study|
|Study Start Date :||December 2003|
|Estimated Study Completion Date :||September 2005|
- Objective response
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226798
|Contact: Eliahu Gez, MDemail@example.com|
|Rambam medical Center||Recruiting|
|Contact: Eliahu Gez, MD 972-4-8542012 firstname.lastname@example.org|
|Study Chair:||Eliahu Gez, MD||Rambam Health Care Campus|