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Interleukin-2, Interferon Alpha,Capecitabine and Vinblastin for Treatment of Metastatic Renal Cell Carcinoma: A Multicenter Study

Phase 2
18 Years
80 Years
Open (Enrolling)
Adenocarcinoma Clear Cell

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Trial Information

Interleukin-2, Interferon Alpha,Capecitabine and Vinblastin for Treatment of Metastatic Renal Cell Carcinoma: A Multicenter Study

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 &

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response

Principal Investigator

Eliahu Gez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rambam Health Care Campus


Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

December 2003

Completion Date:

September 2005

Related Keywords:

  • Adenocarcinoma Clear Cell
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Renal Cell
  • Adenocarcinoma, Clear Cell