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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	over 18	NCI	RPMI-DS-9422 NCI-T93-0177D, T93-0177

Objectives

I.  Evaluate the hematologic response of patients with relapsed or refractory 
acute myeloid leukemia treated with recombinant human interleukin-6 (IL-6).

II.  Assess the safety and tolerability of IL-6 administered subcutaneously to 
these patients.

III.  Correlate clinical outcome with in vitro biological parameters.

Entry Criteria

Disease Characteristics:

Acute myeloid leukemia in relapse following or refractory to
conventional therapy

ANC at least 200

Peripheral blast count (PBC) less than 5,000 at screening 1
week prior to therapy
  If not less than 5,000, PBC must be less than 2 x the
  screening PBC 2 days before or on the day of IL-6
  administration

No bleeding worse than grade 1

Platelets consistently at least 20,000 (transfused if
necessary)

Prior/Concurrent Therapy:

More than 4 weeks since any investigational agent

Biologic therapy:
  No prior interleukin-6
  At least 2 weeks since interleukin-2

Chemotherapy:
  At least 3 days since hydroxyurea
  At least 3 weeks since all other chemotherapy
  No concurrent chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  Not specified

Surgery:
  Not specified

Patient Characteristics:

Age:
  Over 18

Performance status:
  ECOG 0-2

Life expectancy:
  More than 6 weeks

Hematopoietic:
  See Disease Characteristics

Hepatic:
  No active hepatitis of any etiology
  Bilirubin no greater than 1.5 x ULN
  SGOT or SGPT no greater than 1.5 x ULN

Renal:
  BUN no greater than 50 mg/dl
  Creatinine no greater than 2.0 mg/dl

Cardiovascular:
  No class III/IV cardiac status
  No history of atrial fibrillation
  No life-threatening arrhythmia documented on EKG
  No cardiac condition requiring medication, including:
     Arrhythmia
     Angina
     Congestive heart failure
        Ejection fraction at least 40%
  No uncontrolled hypertension

Pulmonary:
  Oxygen saturation at least 91%

Other:
  No allergy to gentamicin or its analogs
  No uncontrolled infection
  No AIDS or AIDS-related complex
  No HIV seropositivity
  No concurrent corticosteroids (except as replacement therapy)
  No psychiatric illness (including alcohol/drug abuse) that
     could interfere with compliance
  No altered mental status
  Ability to understand consent form
  No pregnant or nursing women
  Effective contraception required of fertile patients

Expected Enrollment

If at least 1 of the first 9 patients responds, a total of 25 will be entered.

Outline

Biological Response Modifier Therapy.  Interleukin-6 (Serono), Sigosix, IL-6, 
NSC-658932.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Steven Bernstein, MD, Protocol chair(Contact information may not be current)		Ph: 877-275-7724; 800-685-6825