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Home > "I" Clinical Trials Conditions > Interferon alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer  Interferon alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer
Interferon alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer
For Condition: stage 4 renal cell cancer,recurrent renal cell cancer,Renal Cell Adenocarcinoma
Status: No longer recruiting
Sponsor(s): EORTC Genito-Urinary Tract Cancer Cooperative Group ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic renal cell adenocarcinoma; Histologic confirmation of metastases desirable; Progression of metastases within 2 months of study; No clinically manifest CNS metastasis - Bidimensionally measurable metastases, as follows: Lung lesion with diameter greater than 2 cm; Superficial lymph node or skin or subcutaneous lesion with diameter greater than 2.5 cm; Lymph node in the mediastinum or retroperitoneal region, liver lesion, or soft tissue lesion visible on CT or ultrasound with initial diameter greater than 2.5 cm; No bone lesion without surrounding, measurable soft tissue lesion --Prior/Concurrent Therapy-- - Biologic therapy: No prior immunotherapy - Chemotherapy: No prior chemotherapy - Endocrine therapy: No concurrent hormonal therapy - Radiotherapy: At least 3 months since irradiation of target lesions; Subsequent progression or new lesion required; No concurrent radiotherapy - Surgery: Prior nephrectomy required; No concurrent surgery - Other: No concurrent tetracyclines or hepatotoxic drugs --Patient Characteristics-- - Age: 18 to 75 - Performance status: WHO 0 or 1 - Life expectancy: At least 90 days - Hematopoietic: WBC greater than 3,000/mm3 OR Absolute granulocyte count greater than 1,500/mm3 OR Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin no greater than 1.1 mg/dL; Lipids no greater than 1.5 times normal - Renal: Creatinine no greater than 1.6 mg/dL - Cardiovascular: No congestive heart failure; No significant arrhythmia; No complete bundle branch block - Pulmonary: No serious concurrent pulmonary illness - Other: No recent uncontrolled bleeding; No serous effusion; No history of autoimmune disease; No controlled or uncontrolled active infection; No seizure disorder or compromised CNS function; No secondary gastrointestinal dysfunction that could interfere with drug absorption; No psychological condition that would preclude participation or consent; No second malignancy except basal cell skin cancer or carcinoma in situ of the cervix; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NinaAass, Study Chair, EORTC Genito-Urinary Tract Cancer Cooperative Group
Ospedale di Circolo e Fondazione Macchi
Varese, , 21100
Italy
Groot Ziekengasthuis 's-Hertogenbosch
Hertogenbosch, , 5211 NL
Netherlands
Bristol Royal Infirmary
Bristol, England, BS2 8HW
United Kingdom
National Institute of Oncology
Budapest, , 1125
Hungary
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, , B-9300
Belgium
Ratisches Kantons und Regionalspital
Chur, , CH-7000
Switzerland
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Inselspital, Bern
Bern, , CH-3010
Switzerland
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
Academisch Medisch Centrum
Amsterdam, , 1105 AZ
Netherlands
University Medical Center Nijmegen
Nijmegen, , NL-6252 HB
Netherlands
Russian Academy of Medical Sciences Cancer Research Center
Moscow, , 115478
Russian Federation
Kantonspital Aarau
AARAU, , 5001
Switzerland
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Kantonsspital - Saint Gallen
Saint Gallen, , CH-9007
Switzerland
Institut Jules Bordet
Brussels, , 1000
Belgium
University Hospital - Rotterdam Dijkzigt
Rotterdam, , 3000 CA
Netherlands
Marmara University Hospital
Istanbul, , 81190
Turkey
Ospedale San Giovanni
Bellinzona, , CH-6500
Switzerland
Academisch Ziekenhuis Utrecht
Utrecht, , 3508 GA
Netherlands
Universitaetsspital
Zurich, , CH-8091
Switzerland
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Algemeen Ziekenhuis Middelheim
Antwerp, , 2020
Belgium
Additional Information:
Study ID Numbers: CDR0000064647; EORTC-30951
Study Start Date: March 1996
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002737
Other Stage 4 Renal Cell Cancer Studies:
1. Interferon alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer
2. Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
3. Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other Clinical Trials
Other Budapest Clinical Trials
Interferon alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer
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