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	18 and over		CCF-RPC-3272F NCI-B93-0005, B93-0005

Objectives

I.  Evaluate the response to interleukin-6 (IL-6) in patients with metastatic 
renal cell cancer.

II.  Characterize the toxicity of IL-6 administered subcutaneously on a 
repetitive schedule.

III.  Determine, in selected patients, the effects of IL-6 on the following:  
monocyte/macrophage cytokine secretion and gene expression; peripheral blood 
lymphocyte gene expression; and tumor-infiltrating cell populations and in 
situ gene expression in tumor biopsy specimens.

Entry Criteria

Disease Characteristics:

Histologically proven renal cell cancer that is metastatic and
surgically unresectable
  Minimal prior therapy allowed

Bidimensionally measurable disease required

No CNS metastases
  Normal neurologic examination and normal CT of the head
  (i.e., no evidence of metastases) required

No significant effusions and/or ascites

Prior/Concurrent Therapy:

Biologic therapy:
  No prior interleukin-6
  At least 14 days since other immunotherapy

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  More than 28 days since radiotherapy

Surgery:
  At least 21 days since surgery requiring general anesthesia

Patient Characteristics:

Age:
  At least 18

Performance status:
  ECOG 0 or 1

Life expectancy:
  At least 12 weeks

Hematopoietic:
  WBC at least 3,500
  AGC at least 1,500
  Platelets at least 100,000
  Hb at least 10.0 g/dl

Hepatic:
  Bilirubin no greater than 1.5 mg/dl
  PT and PTT normal

Renal:
  Creatinine no greater than 1.8 mg/dl
  Calcium no greater than 11.0 mg/dl

Cardiovascular:
  LVEF at least 50%
  No NYHA class 3/4 status
  No history of MI
  No history of CHF
  No history of angina
  No history of arrhythmia requiring treatment
  No history of thrombotic episode

Pulmonary:
  DLCO at least 50%
  FEV1/FVC at least 80% of predicted
  No dyspnea at rest or with minimal/moderate exercise

Other:
  No requirement for corticosteroids
  No active infection requiring antibiotics within the previous
     21 days
  No history of seizure disorder
  No diabetes mellitus
  No HIV or HBsAg positivity
  No second malignancy within 3 years except:
     Basal cell carcinoma of the skin
     Carcinoma in situ of the cervix
  No pregnant women
     Negative pregnancy test required of fertile women
  Effective contraception required of fertile patients

Blood/body fluid analyses to determine eligibility and imaging
studies and physical exams for tumor measurement completed
within 14 days prior to registration; screening exams (other
than blood/body fluid analyses) and imaging studies of
nonmeasurable disease or uninvolved organs completed within 28
days prior to registration

Expected Enrollment

Up to 25 patients will be evaluated.  If no responses are seen in the first 14 
patients treated, the study will be closed.  Accrual is expected to be 
completed within 6 to 12 months.

Outline

Biological Response Modifier Therapy.  Interleukin-6 (Sandoz), IL-6, 
NSC-643497.

Trial Contact Information

Trial Lead Organizations

Cleveland Clinic Foundation Hospital

Ronald Bukowski, MD, Protocol chair		Ph: 216-444-6825; 800-862-7798