Immunochemotherapy for Metastatic Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Roche Pharma AG
Information provided by:
Rambam Health Care Campus

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 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

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 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 &

Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interleukin-2, Interferon Alpha,Capecitabine and Vinblastin for Treatment of Metastatic Renal Cell Carcinoma: A Multicenter Study
Study Start Date : December 2003
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Objective response

Secondary Outcome Measures :
  1. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00226798

Contact: Eliahu Gez, MD 972-4-8542012

Rambam medical Center Recruiting
Haifa, Israel
Contact: Eliahu Gez, MD    972-4-8542012   
Sponsors and Collaborators
Rambam Health Care Campus
Roche Pharma AG
Study Chair: Eliahu Gez, MD Rambam Health Care Campus Identifier: NCT00226798     History of Changes
Other Study ID Numbers: 1747CTIL
Raphael Rubinov
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: January 4, 2006
Last Verified: September 2005

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma, Clear Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents