Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 75		EORTC-30951 NCT00002737

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.

Entry 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

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

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

Expected Enrollment

A total of 296 patients will be accrued for this study.

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.

Aass N, De Mulder PH, Mickisch GH, et al.: 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 23 (18): 4172-8, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Nina Aass, MD, Protocol chair		Ph: 47-2293-4000

Registry Information
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
Trial Start Date		1996-03-05
Registered in ClinicalTrials.gov		NCT00002737
Date Submitted to PDQ		1997-06-01
Information Last Verified		2007-05-08

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