Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	16 and over	NCI	IDB-IL4/RENAL AECM-9003064, CHNMC-COH-9002290041, LUMC-2348, NEMCH-CSU-1918, UTHSC-8905011209, NCI-T90-0032O, T90-0032

Objectives

I.  Determine response rate and response duration in patients with metastatic 
renal cell carcinoma treated with interleukin-4.
II.  Determine the toxicity of this regimen in this patient population.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 16 years of age 
with histologically confirmed metastatic or unresectable renal cell carcinoma 
that is incurable.  Bidimensionally measurable disease that is clearly 
progressive is required; bone lesions are not considered measurable disease.  
Prior treatment with interleukin-2 is not permitted, but patients may be 
eligible if treated with no more than one of the following biological response 
modifiers:  a monoclonal antibody; interferon-alpha, -beta, or -gamma; BCG 
vaccine; interleukins (other than IL-2); tumor necrosis factor; or other 
cytokines or biologic response modifiers.  At least 4 weeks must have 
intervened since prior immunotherapy, chemotherapy, or radiotherapy.  No more 
than one prior chemotherapy regimen is permitted, and concurrent radiotherapy 
or chemotherapy are not allowed.  Patients must be ambulatory with good 
performance status (ECOG 1 or better or Karnofsky 80-100%) and have a life 
expectancy of at least 4 months.  Adequate hematologic, hepatic, and renal 
function must be documented as follows:  WBC greater than 3,500 and platelets 
greater than 100,000; bilirubin normal; and creatinine no more than 1.5 mg/dl 
or calculated creatinine clearance at least 60 ml/minute.  There must be no 
evidence of congestive heart failure, symptoms of coronary artery disease, 
serious cardiac arrhythmias, evidence of prior myocardial infarction on EKG, 
or contraindication to the use of pressor agents; patients over age 50 or with 
known risk factors for coronary artery disease must have no evidence of 
ischemic changes on stress treadmill exam.  Evidence of chronic obstructive 
pulmonary disease, active infection that requires antibiotic therapy, brain 
metastasis, and seizure disorders exclude.  The following conditions also 
exclude:  history of GI bleeding or peptic ulcer disease, positive ELISA or 
Western blot test for HIV antibody, positive HBsAg test, organ allografts, 
current or anticipated requirement for corticosteroids for intercurrent 
disease, history of a second malignancy other than basal cell carcinoma, and 
significant medical disease other than the malignancy.  Heavy smokers and 
patients with ascites or pleural effusions are ineligible.  Fertile women must 
have a negative pregnancy test.

Expected Enrollment

If one or more responses are seen among the first 14 patients, a total of 35 
patients will be entered into this multicenter study.  It is expected that 2 
patients/month will be entered and that 18 months will be required for accrual 
of 35 patients.

Outline

Nonrandomized study.
Biological Response Modifier Therapy.  Interleukin-4 (Sterling), IL-4, 
NSC-620211.

Trial Contact Information

Trial Lead Organizations

NCI - Cancer Therapy Evaluation Program

Mario Sznol, MD, Protocol chair		Ph: 203-498-4210