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/MELANOMA NCI-T93-0049N, T93-0049

Objectives

I.  Determine the objective response rate to interleukin-6 administered as a 
1-hour intravenous infusion daily x 5 for 2 weeks every 28 days in patients 
with metastatic or locally advanced melanoma.

II.  Gather additional data on the toxicity of this regimen.

Entry Criteria

Disease Characteristics:

Histologically documented metastatic or locally advanced
melanoma not curable by surgery

Bidimensionally measurable, previously unirradiated disease
required
  
No evidence or history of brain metastases

Prior/Concurrent Therapy:

At least 4 weeks since therapy for melanoma
No concurrent antimelanoma therapy
No concurrent investigational therapy

Biologic therapy:
  Prior adjuvant interferon alpha allowed
  Prior tumor vaccine given adjuvantly or for advanced disease
     allowed
  No prior interleukin-2
  No other prior biologic therapy or immunotherapy

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  Prior radiotherapy to a single site outside the brain allowed

Surgery:
  Not specified

Other:
  No prior organ allograft

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 100,000-600,000
  Hb at least 9.0 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
  PT/PTT no more than 1.2 x ULN
  Albumin at least 3.0 g/dl and tumor involves less than 2/3 of
     liver parenchyma on CT scan

Renal:
  Creatinine no more than 2.0 mg/dl

Cardiovascular:
  No history of MI
  No CHF
  No symptoms of coronary artery disease
  No chronic arrhythmia requiring treatment
  No peripheral arterial insufficiency
  No history of thrombotic episodes
  No hypertension requiring treatment

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

Other:
  No infection requiring antibiotics within 1 week of starting
     therapy
  No requirement for corticosteroids
  No seizure disorder requiring medication
  No diabetes mellitus requiring insulin or oral hypoglycemics
  No autoimmune disease except autoimmune thyroid disease or
     vitiligo
  No HIV positivity by ELISA and Western blot
  No HBsAg positivity
  No chronic hepatitis C infection
  No medical or psychiatric condition that would preclude
     protocol therapy
  Adequate peripheral venous access or the placement of a semi-
     permanent venous access device required
  No second malignancy within 5 years except:
     Carcinoma in situ of the cervix
     Basal cell carcinoma
  Negative pregnancy test required of fertile women
  Adequate contraception required of fertile women

Expected Enrollment

Up to 30 patients will be entered at a rate of 3-5 patients/month.  If none of 
the first 14 patients responds, the study will be terminated.

Outline

Nonrandomized study.

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

Sznol M, Mier J, Dutcher JP, et al.: A phase II trial of a daily 1-hour intravenous infusion of interleukin-6 (rHuIL-6) for metastatic malignant melanoma (MM). [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-1348, 396, 1994.

Trial Contact Information

Trial Lead Organizations

NCI - Cancer Therapy Evaluation Program

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