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
18 Years
75 Years
Both
Kidney Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Nina Aass, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Norwegian Radium Hospital
Authority:
United States: Federal Government
Study ID:
EORTC-30951
NCT ID:
NCT00002737
Start Date:
March 1996
Completion Date:
Related Keywords:
- Kidney Cancer
- stage IV renal cell cancer
- recurrent renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
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