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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	17 and over	NCI	MDA-DM-93081 NCI-T93-0130C, T93-0130

Objectives

I.  Evaluate the thrombopoietic potential and effect on blast counts of 
interleukin-6 (IL-6) in patients with acute myelogenous leukemia in smoldering 
relapse.

II.  Assess the toxicity of IL-6 in these patients.

III.  Assess the effects of IL-6 on cell-cycle status and in vitro cytarabine 
sensitivity of blasts obtained from these patients.

IV.  Characterize the pharmacology of IL-6.

Entry Criteria

Disease Characteristics:

Confirmed diagnosis of AML (FAB criteria)

Relapse after initial first remission lasting less than 1 year
and characterized by all of the following:
  Marrow blasts 5-30%
     Excess blasts must be confirmed by a second marrow
     exam if 5-10% at first exam
  Circulating blasts less than 5,000
  Platelets less than 100,000

Prior/Concurrent Therapy:

No more than 1 prior regimen for relapsed disease
At least 2 weeks since chemotherapy or growth factor therapy
No concurrent steroids

Patient Characteristics:

Age:
  17 and over

Performance status:
  Zubrod 0-2

Hematopoietic:
  See Disease Characteristics

Hepatic:
  Bilirubin less than 1.6 mg/dl

Renal:
  Creatinine less than 1.6 mg/dl

Cardiovascular:
  No CHF
  No arrhythmia requiring treatment
  No active coronary artery disease
  No thromboembolic disease

Pulmonary:
  No dyspnea at rest or with minimal exertion

Other:
  No HIV or HBsAg positivity
  No autoimmune disease
  No pregnant or nursing women

Expected Enrollment

Up to 24 patients will be accrued over 1 year; if no response is observed in 
the first 9 patients, accrual will cease.

Outline

Nonrandomized study.

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

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Elihu Estey, MD, Protocol chair(Contact information may not be current)		Ph: 713-792-7544; 800-392-1611