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
Groot Ziekengasthuis 's-Hertogenbosch
🇳🇱Hertogenbosch, Netherlands
Kantonsspital - Saint Gallen
🇨ðŸ‡Saint Gallen, Switzerland
Universitaetsspital
🇨ðŸ‡Zurich, Switzerland
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Beatson Oncology Centre
🇬🇧Glasgow, Scotland, United Kingdom
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Institut Jules Bordet
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Antoni van Leeuwenhoekhuis
🇳🇱Amsterdam, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Norwegian Radium Hospital
🇳🇴Oslo, Norway
University Hospital - Rotterdam Dijkzigt
🇳🇱Rotterdam, Netherlands
Rotterdam Cancer Institute
🇳🇱Rotterdam, Netherlands
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
National Institute of Oncology
ðŸ‡ðŸ‡ºBudapest, Hungary
Ratisches Kantons und Regionalspital
🇨ðŸ‡Chur, Switzerland
Marmara University Hospital
🇹🇷Istanbul, Turkey
Academisch Ziekenhuis Utrecht
🇳🇱Utrecht, Netherlands
Kantonspital Aarau
🇨ðŸ‡Aarau, Switzerland
Ospedale San Giovanni
🇨ðŸ‡Bellinzona, Switzerland
Russian Academy of Medical Sciences Cancer Research Center
🇷🇺Moscow, Russian Federation
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Inselspital, Bern
🇨ðŸ‡Bern, Switzerland
Bristol Royal Infirmary
🇬🇧Bristol, England, United Kingdom