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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002737 |
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 | Intervention | Phase |
---|---|---|
Kidney Cancer |
Biological: recombinant interferon alfa Drug: chemotherapy Drug: isotretinoin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
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 |
Estimated Enrollment: | 296 |
Study Start Date: | March 1996 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
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
Belgium | |
Algemeen Ziekenhuis Middelheim | |
Antwerp, Belgium, 2020 | |
Institut Jules Bordet | |
Brussels, Belgium, 1000 | |
Onze Lieve Vrouw Ziekenhuis Aalst | |
Aalst, Belgium, B-9300 | |
U.Z. Gasthuisberg | |
Leuven, Belgium, B-3000 | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, B-2650 | |
Hungary | |
National Institute of Oncology | |
Budapest, Hungary, 1125 | |
Italy | |
Ospedale di Circolo e Fondazione Macchi | |
Varese, Italy, 21100 | |
Netherlands | |
Academisch Medisch Centrum | |
Amsterdam, Netherlands, 1105 AZ | |
Academisch Ziekenhuis Utrecht | |
Utrecht, Netherlands, 3508 GA | |
Antoni van Leeuwenhoekhuis | |
Amsterdam, Netherlands, 1066 CX | |
Rotterdam Cancer Institute | |
Rotterdam, Netherlands, 3075 EA | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 CA | |
Groot Ziekengasthuis 's-Hertogenbosch | |
Hertogenbosch, Netherlands, 5211 NL | |
University Hospital - Rotterdam Dijkzigt | |
Rotterdam, Netherlands, 3000 CA | |
University Medical Center Nijmegen | |
Nijmegen, Netherlands, NL-6252 HB | |
Norway | |
Norwegian Radium Hospital | |
Oslo, Norway, N-0310 | |
Russian Federation | |
Russian Academy of Medical Sciences Cancer Research Center | |
Moscow, Russian Federation, 115478 | |
Switzerland | |
Kantonspital Aarau | |
Aarau, Switzerland, 5001 | |
Inselspital, Bern | |
Bern, Switzerland, CH-3010 | |
Centre Hospitalier Universitaire Vaudois | |
Lausanne, Switzerland, CH-1011 | |
Kantonsspital - Saint Gallen | |
Saint Gallen, Switzerland, CH-9007 | |
Ospedale San Giovanni | |
Bellinzona, Switzerland, CH-6500 | |
Ratisches Kantons und Regionalspital | |
Chur, Switzerland, CH-7000 | |
Universitaetsspital | |
Zurich, Switzerland, CH-8091 | |
Turkey | |
Marmara University Hospital | |
Istanbul, Turkey, 81190 | |
United Kingdom, England | |
Bristol Royal Infirmary | |
Bristol, England, United Kingdom, BS2 8HW | |
United Kingdom, Scotland | |
Beatson Oncology Centre | |
Glasgow, Scotland, United Kingdom, G11 6NT |
Study Chair: | Nina Aass, MD | Norwegian Radium Hospital |
Study ID Numbers: | CDR0000064647, EORTC-30951 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002737 History of Changes |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer recurrent renal cell cancer |
Interferon-alpha Anti-Infective Agents Urinary Tract Neoplasm Interferon Type I, Recombinant Kidney Cancer Immunologic Factors Interferons Urogenital Neoplasms Urologic Neoplasms Angiogenesis Inhibitors Antiviral Agents Recurrence |
Carcinoma Renal Cancer Urologic Diseases Kidney Neoplasms Isotretinoin Carcinoma, Renal Cell Tretinoin Kidney Diseases Interferon Alfa-2a Adenocarcinoma Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Isotretinoin Growth Inhibitors Kidney Diseases Angiogenesis Modulating Agents |
Dermatologic Agents Interferon-alpha Neoplasms by Histologic Type Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Carcinoma, Renal Cell Adenocarcinoma Interferon Alfa-2a Neoplasms, Glandular and Epithelial |