Interferon Alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer
- Conditions
- Kidney Cancer
- Registration Number
- NCT00002737
- Brief Summary
RATIONALE: Interferon alfa may interfere with the growth of the cancer cells and slow the growth of kidney cancer. Isotretinoin may help kidney cancer cells develop into normal cells. It is not yet known whether interferon alfa plus isotretinoin is more effective than interferon alfa alone for kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without isotretinoin in treating patients who have metastatic kidney cancer.
- Detailed Description
OBJECTIVES: I. Assess the response rate and response duration of interferon alfa with vs without isotretinoin in patients with bidimensionally measurable progressive metastases from renal cell cancer. II. Assess the toxic effects of these regimens in this patients population. III. Determine the overall survival of this patient population treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of two treatment arms. Arm I: Patients receive interferon alfa subcutaneously daily. Arm II: Patients receive interferon alfa as in arm I plus oral isotretinoin daily. Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed until death.
PROJECTED ACCRUAL: A total of 296 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Onze Lieve Vrouw Ziekenhuis Aalst
🇧🇪Aalst, Belgium
Algemeen Ziekenhuis Middelheim
🇧🇪Antwerp, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
National Institute of Oncology
🇭🇺Budapest, Hungary
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Antoni van Leeuwenhoekhuis
🇳🇱Amsterdam, Netherlands
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Groot Ziekengasthuis 's-Hertogenbosch
🇳🇱Hertogenbosch, Netherlands
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