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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	16 and over	NCI	IDB-IL-6/120HR NCI-T92-0062O, T92-0062

Objectives

I.  Determine the MTD and toxicity of interleukin-6 (IL-6) when administered 
as a 120-hour intravenous infusion to patients with advanced or metastatic 
cancer.

II.  Evaluate the pharmacologic effects of IL-6 administered in this manner to 
this patient population.

Entry Criteria

Disease Characteristics:

Locally advanced or metastatic cancer that has failed or is
refractory to standard curative therapy or for which no known
standard curative or palliative therapy exists

  No lymphoproliferative disorders, leukemia, or lymphoma

Measurable or evaluable disease required

No history or evidence of brain metastases

Prior/Concurrent Therapy:

No other concurrent investigational treatment

Biologic therapy:
  At least 6 weeks since prior biological response modifier
     therapy

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

Endocrine therapy:
  At least 4 weeks since prior endocrine therapy
  No requirement for corticosteroids

Radiotherapy:
  At least 4 weeks since prior radiotherapy
  No requirement for radiotherapy

Surgery:
  At least 4 weeks since prior surgery

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 at least 100,000 and no more than 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 within ULN

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 by 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

Other:
  Adequate peripheral venous access or placement of a semi-
     permanent venous access device required
  No HIV or HBsAg seropositivity
  No medical or psychiatric condition that would unacceptably
     reduce safety of proposed treatment, impair delivery of
     treatment, or preclude informed consent
  No active infection requiring antibiotics within 1 week of
     study
  No autoimmune disease except:
     Autoimmune thyroid disease
     Vitiligo
  No seizure disorder controlled with medication
  No second malignancy within 5 years except:
     Basal cell carcinoma
     Cervical carcinoma in situ
  Negative pregnancy test required of fertile women
  Effective contraception required of fertile women 

Expected Enrollment

Six patients will be entered at each dose studied.

Outline

Nonrandomized study.

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

Aronson FR, Sznol M, Mier JW, et al.: Interleukin-6: phase I trials of 1 and 120 hour intravenous infusions. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-952, 292, 1993.

Trial Contact Information

Trial Lead Organizations

NCI - Cancer Therapy Evaluation Program

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