Spots Global Cancer Trial Database for Interferon Alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer
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Trial Identification
Brief Title: Interferon Alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer
Official Title: A RANDOMIZED PHASE II TRIAL OF INTERFERON ALPHA-2A WITH AND WITHOUT 13-CIS RETINOIC ACID IN PATIENTS WITH PROGRESSIVE MEASURABLE METASTATIC RENAL CELL CARCINOMA. Amendment Protocol: Extension to a Randomized Phase III Trial
Study ID: NCT00002737
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Leiden University Medical Center, Leiden, , Netherlands
University Medical Center Nijmegen, Nijmegen, , Netherlands
University Hospital - Rotterdam Dijkzigt, Rotterdam, , Netherlands
Rotterdam Cancer Institute, Rotterdam, , Netherlands
Academisch Ziekenhuis Utrecht, Utrecht, , Netherlands
Norwegian Radium Hospital, Oslo, , Norway
Russian Academy of Medical Sciences Cancer Research Center, Moscow, , Russian Federation
Kantonspital Aarau, Aarau, , Switzerland
Ospedale San Giovanni, Bellinzona, , Switzerland
Inselspital, Bern, Bern, , Switzerland
Ratisches Kantons und Regionalspital, Chur, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kantonsspital - Saint Gallen, Saint Gallen, , Switzerland
Universitaetsspital, Zurich, , Switzerland
Marmara University Hospital, Istanbul, , Turkey
Bristol Royal Infirmary, Bristol, England, United Kingdom
Beatson Oncology Centre, Glasgow, Scotland, United Kingdom
Contact Details
Name: Nina Aass, MD
Affiliation: Norwegian Radium Hospital
Role: STUDY_CHAIR
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