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

Condition(s) targeted: Kidney Cancer

Intervention: isotretinoin (Drug); recombinant interferon alfa (Drug); chemotherapy (Procedure)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: European Organization for Research and Treatment of Cancer

Official(s) and/or principal investigator(s):
Nina Aass, MD, Study Chair, Affiliation: Norwegian Radium Hospital

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.

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 design: Treatment, Randomized

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

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

Algemeen Ziekenhuis Middelheim, Antwerp 2020, Belgium

Institut Jules Bordet, Brussels 1000, Belgium

Onze Lieve Vrouw Ziekenhuis Aalst, Aalst B-9300, Belgium

U.Z. Gasthuisberg, Leuven B-3000, Belgium

Universitair Ziekenhuis Antwerpen, Edegem B-2650, Belgium

National Institute of Oncology, Budapest 1125, Hungary

Ospedale di Circolo e Fondazione Macchi, Varese 21100, Italy

Academisch Medisch Centrum, Amsterdam 1105 AZ, Netherlands

Academisch Ziekenhuis Utrecht, Utrecht 3508 GA, Netherlands

Antoni van Leeuwenhoekhuis, Amsterdam 1066 CX, Netherlands

Groot Ziekengasthuis 's-Hertogenbosch, Hertogenbosch 5211 NL, Netherlands

Leiden University Medical Center, Leiden 2300 CA, Netherlands

Rotterdam Cancer Institute, Rotterdam 3075 EA, Netherlands

University Hospital - Rotterdam Dijkzigt, Rotterdam 3000 CA, Netherlands

University Medical Center Nijmegen, Nijmegen NL-6252 HB, Netherlands

Norwegian Radium Hospital, Oslo N-0310, Norway

Russian Academy of Medical Sciences Cancer Research Center, Moscow 115478, Russian Federation

Centre Hospitalier Universitaire Vaudois, Lausanne CH-1011, Switzerland

Inselspital, Bern, Bern CH-3010, Switzerland

Kantonspital Aarau, Aarau 5001, Switzerland

Kantonsspital - Saint Gallen, Saint Gallen CH-9007, Switzerland

Ospedale San Giovanni, Bellinzona CH-6500, Switzerland

Ratisches Kantons und Regionalspital, Chur CH-7000, Switzerland

Universitaetsspital, Zurich CH-8091, Switzerland

Marmara University Hospital, Istanbul 81190, Turkey

Bristol Royal Infirmary, Bristol, England BS2 8HW, United Kingdom

Beatson Oncology Centre, Glasgow, Scotland G11 6NT, United Kingdom

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 1996
Last updated: May 23, 2008