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

NCT00002737 | Completed Phase 3

• 1 other identifier: EORTC-30951
• Study Type: interventional
• Target: 320
• Locations: 9 countries
• Sites: 27

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.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer; recurrent renal cell cancer

Interventions

recombinant interferon alfa BIOLOGICAL

chemotherapy DRUG

isotretinoin DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (27)

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, B-9300, Belgium

Location

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

National Institute of Oncology

Budapest, 1125, Hungary

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Groot Ziekengasthuis 's-Hertogenbosch

's-Hertogenbosch, 5211 NL, Netherlands

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6252 HB, Netherlands

Location

University Hospital - Rotterdam Dijkzigt

Rotterdam, 3000 CA, Netherlands

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3508 GA, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Russian Academy of Medical Sciences Cancer Research Center

Moscow, 115478, Russia

Location

Kantonspital Aarau

Aarau, 5001, Switzerland

Location

Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Ratisches Kantons und Regionalspital

Chur, CH-7000, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital - Saint Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Universitaetsspital

Zurich, CH-8091, Switzerland

Location

Marmara University Hospital

Istanbul, 81190, Turkey (Türkiye)

Location

Bristol Royal Infirmary

Bristol, England, BS2 8HW, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (1)

• Aass N, De Mulder PH, Mickisch GH, Mulders P, van Oosterom AT, van Poppel H, Fossa SD, de Prijck L, Sylvester RJ. Randomized phase II/III trial of interferon Alfa-2a with and without 13-cis-retinoic acid in patients with progressive metastatic renal cell Carcinoma: the European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group (EORTC 30951). J Clin Oncol. 2005 Jun 20;23(18):4172-8. doi: 10.1200/JCO.2005.07.114.

  PMID: 15961764 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Interferon-alpha; Drug Therapy; Isotretinoin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Therapeutics; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological

Study Officials

• Nina Aass, MD

  Norwegian Radium Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 11, 2004
• Study Start: March 1, 1996
• Primary Completion: January 1, 2001
• Last Updated: July 11, 2012

Record last verified: 2012-07

Locations

GB (2); HU (1); RU (1); CH (7); BE (5); NO (1); TU (1); IT (1); NL (8)