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Trial record 67 of 165 for:    ISOTRETINOIN

Interferon Alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002737
Recruitment Status : Completed
First Posted : May 11, 2004
Last Update Posted : July 11, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: recombinant interferon alfa Drug: chemotherapy Drug: isotretinoin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : March 1996
Actual Primary Completion Date : January 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002737

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Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Belgium, B-9300
Algemeen Ziekenhuis Middelheim
Antwerp, Belgium, 2020
Institut Jules Bordet
Brussels, Belgium, 1000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
National Institute of Oncology
Budapest, Hungary, 1125
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Groot Ziekengasthuis 's-Hertogenbosch
Hertogenbosch, Netherlands, 5211 NL
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6252 HB
University Hospital - Rotterdam Dijkzigt
Rotterdam, Netherlands, 3000 CA
Rotterdam Cancer Institute
Rotterdam, Netherlands, 3075 EA
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, 3508 GA
Norwegian Radium Hospital
Oslo, Norway, N-0310
Russian Federation
Russian Academy of Medical Sciences Cancer Research Center
Moscow, Russian Federation, 115478
Kantonspital Aarau
Aarau, Switzerland, 5001
Ospedale San Giovanni
Bellinzona, Switzerland, CH-6500
Inselspital, Bern
Bern, Switzerland, CH-3010
Ratisches Kantons und Regionalspital
Chur, Switzerland, CH-7000
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Kantonsspital - Saint Gallen
Saint Gallen, Switzerland, CH-9007
Zurich, Switzerland, CH-8091
Marmara University Hospital
Istanbul, Turkey, 81190
United Kingdom
Bristol Royal Infirmary
Bristol, England, United Kingdom, BS2 8HW
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Nina Aass, MD Norwegian Radium Hospital

Publications of Results:
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00002737     History of Changes
Other Study ID Numbers: EORTC-30951
First Posted: May 11, 2004    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IV renal cell cancer
recurrent renal cell cancer
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents