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Immunochemotherapy for Metastatic Renal Cell Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00226798
First received: September 26, 2005
Last updated: December 31, 2005
Last verified: September 2005
  Purpose

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 Intervention Phase
Adenocarcinoma Clear Cell
Drug: Capecitabine (Xeloda)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interleukin-2, Interferon Alpha,Capecitabine and Vinblastin for Treatment of Metastatic Renal Cell Carcinoma: A Multicenter Study

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Objective response

Secondary Outcome Measures:
  • Toxicity

Estimated Enrollment: 45
Study Start Date: December 2003
Estimated Study Completion Date: September 2005
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 &

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226798

Contacts
Contact: Eliahu Gez, MD 972-4-8542012 e_gez@rambam.health.gov.il

Locations
Israel
Rambam medical Center Recruiting
Haifa, Israel
Contact: Eliahu Gez, MD    972-4-8542012    e_gez@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Roche Pharma AG
Investigators
Study Chair: Eliahu Gez, MD Rambam Health Care Campus
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00226798     History of Changes
Other Study ID Numbers: 1747CTIL, Raphael Rubinov
Study First Received: September 26, 2005
Last Updated: December 31, 2005
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on November 24, 2014