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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	16 and over	NCI	IDB-IL-6 NCI-T92-0049O, T92-0049

Objectives

I.  Determine the MTD and toxicity of interleukin-6 (IL-6) administered as a 
1-hour intravenous infusion in patients with solid tumors.

II.  Evaluate the pharmacologic effects of IL-6 administered on this schedule 
to this patient population.

Entry Criteria

Disease Characteristics:

Locally advanced or metastatic malignancy (excluding lymphoma
or leukemia) that has failed or is refractory to standard
curative or palliative therapy or for which no such therapy
exists

Measurable or evaluable disease required

No brain metastases

No lymphoproliferative disease

Prior/Concurrent Therapy:

Biologic therapy:
  At least 4 weeks since prior biological response modifier
     therapy

Chemotherapy:
  At least 4 weeks since prior chemotherapy (6 weeks for
     nitrosoureas)

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 4 weeks since prior radiotherapy
  No concurrent radiotherapy

Surgery:
  Not specified

Other:
  No prior organ allograft
  No other concurrent investigational therapy
  No requirement for corticosteroids

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 at least 100,000 and no more than 600,000
  Hb at least 9.0 mg/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 within normal limits
  HBsAg negative

Renal:
  Creatinine no more than 2.0 mg/dl

Cardiovascular:
  No significant cardiovascular disease, i.e.:
     No symptoms of coronary artery disease (including those
        controlled with medication)
     No history of MI within 6 months
     No CHF
     No chronic arrhythmia requiring treatment
     No peripheral arterial insufficiency

Pulmonary:
  No clinical evidence of pulmonary dysfunction or asthma

Other:
  HIV seronegative
  No seizure disorder
  No autoimmune disease except:
     Autoimmune thyroid disease
     Vitiligo
  No infection requiring antibiotics within 1 week of entry
  No second malignancy within 5 years except:
    In situ cervical cancer
    Basal cell carcinoma
  No medical or psychiatric condition that would reduce
     safety, impair treatment delivery, or preclude voluntary
     consent and cooperation
  Adequate venous access required
  Negative pregnancy test required of fertile women
  Effective contraception required of fertile women

Expected Enrollment

6 patients will be entered at each dose level studied.

Outline

Nonrandomized study.

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

Trial Contact Information

Trial Lead Organizations

NCI - Cancer Therapy Evaluation Program

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