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

NCT ID: NCT00002737

Last Updated: 2012-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Cancer

Keywords

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stage IV renal cell cancer recurrent renal cell cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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recombinant interferon alfa

Intervention Type BIOLOGICAL

chemotherapy

Intervention Type DRUG

isotretinoin

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nina Aass, MD

Role: STUDY_CHAIR

Norwegian Radium Hospital

Locations

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Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, , Belgium

Site Status

Algemeen Ziekenhuis Middelheim

Antwerp, , Belgium

Site Status

Institut Jules Bordet

Brussels, , Belgium

Site Status

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Site Status

U.Z. Gasthuisberg

Leuven, , Belgium

Site Status

National Institute of Oncology

Budapest, , Hungary

Site Status

Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Site Status

Groot Ziekengasthuis 's-Hertogenbosch

's-Hertogenbosch, , Netherlands

Site Status

Antoni van Leeuwenhoekhuis

Amsterdam, , Netherlands

Site Status

Academisch Medisch Centrum

Amsterdam, , Netherlands

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

University Medical Center Nijmegen

Nijmegen, , Netherlands

Site Status

University Hospital - Rotterdam Dijkzigt

Rotterdam, , Netherlands

Site Status

Rotterdam Cancer Institute

Rotterdam, , Netherlands

Site Status

Academisch Ziekenhuis Utrecht

Utrecht, , Netherlands

Site Status

Norwegian Radium Hospital

Oslo, , Norway

Site Status

Russian Academy of Medical Sciences Cancer Research Center

Moscow, , Russia

Site Status

Kantonspital Aarau

Aarau, , Switzerland

Site Status

Ospedale San Giovanni

Bellinzona, , Switzerland

Site Status

Inselspital, Bern

Bern, , Switzerland

Site Status

Ratisches Kantons und Regionalspital

Chur, , Switzerland

Site Status

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

Kantonsspital - Saint Gallen

Sankt Gallen, , Switzerland

Site Status

Universitaetsspital

Zurich, , Switzerland

Site Status

Marmara University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Bristol Royal Infirmary

Bristol, England, United Kingdom

Site Status

Beatson Oncology Centre

Glasgow, Scotland, United Kingdom

Site Status

Countries

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Belgium Hungary Italy Netherlands Norway Russia Switzerland Turkey (Türkiye) United Kingdom

References

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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.

Reference Type RESULT
PMID: 15961764 (View on PubMed)

Other Identifiers

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EORTC-30951

Identifier Type: -

Identifier Source: secondary_id

EORTC-30951

Identifier Type: -

Identifier Source: org_study_id