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Interferon Alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002737
  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 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 296
Study Start Date: March 1996
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002737

Locations
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
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Study Chair: Nina Aass, MD Norwegian Radium Hospital
  More Information

Additional Information:
Publications:
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

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 01, 2009