Interferon Alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
| Enrollment: | 320 |
| Study Start Date: | March 1996 |
| Primary Completion Date: | January 2001 (Final data collection date for primary outcome measure) |
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| 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
Contacts and Locations| Belgium | |
| 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 | |
| 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 | |
| Antoni van Leeuwenhoekhuis | |
| Amsterdam, Netherlands, 1066 CX | |
| 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 | |
| Rotterdam Cancer Institute | |
| Rotterdam, Netherlands, 3075 EA | |
| University Hospital - Rotterdam Dijkzigt | |
| Rotterdam, Netherlands, 3000 CA | |
| Academisch Ziekenhuis Utrecht | |
| Utrecht, Netherlands, 3508 GA | |
| 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 | |
| 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 | |
| Universitaetsspital | |
| Zurich, Switzerland, CH-8091 | |
| Turkey | |
| 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 | |
| Study Chair: | Nina Aass, MD | Norwegian Radium Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00002737 History of Changes |
| Other Study ID Numbers: | EORTC-30951, EORTC-30951 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 10, 2012 |
| Health Authority: | United States: Federal Government |
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:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Interferon-alpha Interferon Alfa-2a |
Interferons Isotretinoin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013