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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	16 and over	NCI	IDB-IL-6/RENAL NCI-T93-0038N, T93-0038

Objectives

I.  Determine the objective response rate to interleukin-6 administered as a 
120-hour continuous intravenous infusion in patients with advanced renal cell 
carcinoma.

II.  Characterize further the toxicities of this treatment.

Entry Criteria

Disease Characteristics:

Histologically confirmed advanced renal cell carcinoma
(metastatic or surgically incurable)

Bidimensionally measurable, previously unirradiated disease
required

No history of brain metastases

Prior/Concurrent Therapy:

No concurrent investigational treatment
No concurrent treatment for cancer

Biologic therapy:
  No prior IL-2 
  No other immunotherapy allowed except:
     Prior interferon alpha as adjuvant therapy
     Prior tumor vaccine as adjuvant therapy or for advanced
        disease
  At least 6 weeks since interferon alpha
  At least 6 weeks since tumor vaccine therapy

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  One prior hormonal regimen allowed
  No concurrent corticosteroids

Radiotherapy:
  Prior radiotherapy to a single site outside of the brain
     allowed
  At least 4 weeks since radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  16 and over

Performance status:
  ECOG 0 or 1

Life expectancy:
  At least 12 weeks

Hematopoietic:
  WBC at least 3,500
  AGC at least 1,500
  Platelets between 100,000 and 600,000
  Hb at least 9 g/dl

Hepatic:
  Bilirubin no more than 1.5 mg/dl
  SGOT/SGPT no more than 2 x ULN
  Alkaline phosphatase no more than 4 x ULN (unless further
     elevation is related to liver metastases)
  PT/PTT no more than 1.2 x ULN
  Albumin at least 3.0 g/dl
  No more than 2/3 of the liver parenchyma involved with tumor
     (on CT)

Renal:
  Creatinine no more than 2.0 mg/dl

Cardiovascular:
  No symptoms of coronary artery disease (including those
     controlled by medication)
  No MI within 6 months
  No CHF
  No chronic arrhythmia requiring treatment
  No peripheral artery insufficiency
  No hypertension for which antihypertensive medication cannot
     be safely discontinued prior to IL-6 treatment

Pulmonary:
  No dyspnea at rest or with minimal or moderate exertion

Other:
  Adequate peripheral venous access (or placement of a
     semipermanent venous access device) required
  No active infection requiring antibiotics within 1 week of
     therapy
  No diabetes mellitus requiring insulin or oral hypoglycemics
  No autoimmune disease except:
     Vitiligo
     Autoimmune thyroid disease
  No HIV positivity by ELISA and Western Blot
  No HBsAg positivity or chronic hepatitis C
  No organ allografts
  No seizure disorder controlled with medication
  No medical or psychiatric condition that would unacceptably
     reduce the safety of or impair delivery of the proposed
     treatment or preclude voluntary informed consent
  No second malignancy within 5 years except:
     Basal cell carcinoma
     Carcinoma in situ of the cervix
  Negative pregnancy test required of fertile women
  Adequate contraception required of fertile women

Expected Enrollment

Up to 30 patients will be accrued at a rate of 2-4 patients/month.  If no 
response is seen in the first 14 patients, the study will be terminated.

Outline

Nonrandomized study.

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

Weiss GR, Margolin KA, Sznol M, et al.: A phase II trial of a 120-hour continuous intravenous (CIV) infusion of interleukin-6 (rHuIL-6) for metastatic renal cell carcinoma (RCC). [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-779, 248, 1994.

Trial Contact Information

Trial Lead Organizations

NCI - Cancer Therapy Evaluation Program

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