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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Closed 18 to 70 UCCRC-4973C NCI-V87-0312

Objectives

I.  Compare objective response rates among patients with advanced renal cell 
carcinoma randomized to treatment with recombinant interleukin-2 with vs. 
without lymphokine-activated killer cell infusions.
II.  Compare the tolerance and safety of the two treatment regimens in these 
patients.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients aged 18 to 70 years with 
measurable, histologically confirmed metastatic or nonresectable renal cell 
carcinoma provided they have received no previous immunotherapy with 
interleukin-2.  Bone lesions are not considered measurable.  The Karnofsky 
performance status must be at least 80 and the expected survival must be 
greater than 16 weeks.  There may have been no chemotherapy, radiotherapy, or 
other immunosuppressive therapy within 4 weeks of entry (6 weeks for 
mitomycin-C and nitrosoureas), no glucocorticoids within 1 week of entry, and 
no major surgery within 3 weeks of entry.  There must be adequate renal 
function (no hypoalbuminemia, nephrotic syndrome, or creatinine greater than 
2.0 mg/dl) and hepatic function (SGOT not greater than 4 times the upper limit 
of normal, bilirubin not greater than 1.6 mg/dl, and PT and PTT not greater 
than 1.5 times control).  Required minimum parameters of hematologic function 
are Hb 10 g/dl, granulocytes 1,500, and platelets 100,000.  There may be no 
significant pulmonary dysfunction (e.g., FEV1 less than 75% of predicted 
value) and no significant abnormality of the cardiovascular system (e.g., 
congestive heart failure, symptoms of coronary artery disease, a history of 
cardiac arrhythmias, or EKG evidence of a previous myocardial infarction).  
Patients must be free from significant CNS disease, including CNS tumor 
metastases or a history of CNS metastases, psychiatric disabilities, and 
seizure disorders.  The serum calcium must be no greater than 12 mg/dl, and 
patients must be free from symptomatic hypercalcemia.  There may be no other 
prior or concurrent malignancy except for curatively treated basal cell 
carcinoma and carcinoma in situ of the cervix.  Patients with organ allografts 
are ineligible, as are those with abdominal or pleural effusions, positive 
tests for HIV antibody (screened by EIA and confirmed by Western blot) or 
HBsAg, allergy to antibiotics (penicillin, streptomycin, or gentamicin), 
inadequate peripheral veins for leukapheresis, or significant intercurrent 
illness.  Active infectious processes and active peptic ulcer disease must be 
corrected and controlled prior to entry.  Except in cases of life-threatening 
symptoms, glucocorticoids should be excluded during protocol treatment; 
patients who require or are likely to require corticosteroids for intercurrent 
disease should not be entered.  Nonsteroidal anti-inflammatory drugs, 
including aspirin, are excluded during protocol treatment; drugs that may be 
administered for analgesia are acetaminophen, propoxyphene, and, if indicated, 
narcotics.  Women of childbearing potential and fertile men must be using 
effective contraception.  A negative pregnancy test is required of all 
premenopausal women immediately prior to entry; nursing women are excluded.

Expected Enrollment

Up to 120 evaluable patients will be entered.  If the response rate is less 
than 20%, the study will be terminated early.

Outline

Randomized study.
Arm I:  Biological Response Modifier Therapy.  Recombinant Human Interleukin-2 
(Hoffmann-La Roche), rIL-2, NSC-600664.
Arm II:  Biological Response Modifier Therapy.  rIL-2; plus 
Lymphokine-Activated Killer Cells, LAK Cells (activated in vitro with IL-2).

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Nicholas Vogelzang, MD, Protocol chair(Contact information may not be current)		Ph: 773-702-6743; 888-824-0200 Email: nvogelza@medicine.bsd.uchicago.edu