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	18 and over	NCI	NCI-92-C-0143 NCI-T92-0040N, T92-0040

Objectives

I.  Evaluate the toxicity and biologic effects of intravenous interleukin-6 
(IL-6) in patients with advanced cancer who have failed all available standard 
effective therapy.

II.  Determine any therapeutic efficacy of IL-6 in these  patients.

Entry Criteria

Disease Characteristics:

Any malignant solid tumor that has failed standard therapy, if
available
  No B- or T-cell malignancy
  No multiple myeloma
  No lymphoproliferative disease

Measurable disease required

No active CNS metastases

Prior/Concurrent Therapy:

At least 1 month since prior therapy

Patient Characteristics:

Age:  
  18 and over

Performance status:
  ECOG 0-2

Life expectancy:
  More than 3 months

Hematopoietic:
  Platelets at least 80,000

Hepatic:
  Bilirubin less than 1.5 mg/dl
  No coagulation disorder

Renal:
  Creatinine less than 2.0 mg/dl

Cardiovascular:
  No major cardiovascular illness

Pulmonary:
  No major respiratory illness

Other:
  No active autoimmune disease
  No metabolic bone disease
  No active systemic infection
  No requirement for steroid therapy
  Negative HBsAg and HIV Ab
  No pregnant women

Expected Enrollment

At least 3 patients will be accrued at each dose studied.  A total accrual of 
30 patients is expected in 1 year.

Outline

Nonrandomized study.

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

Weber J, Gordon M, Gunn H, et al.: Phase I studies of the administration of subcutaneous or intravenous recombinant IL-6 in patients with advanced cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-974, 298, 1993.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Jeffrey Weber, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 323-865-3962; 800-865-0102 Email: jweber@usc.edu