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 18 and over AECM-9006166 NCI-V90-0129

Objectives

I.  Evaluate the safety and efficacy of recombinant human macrophage colony 
stimulating factor (M-CSF) given by continuous infusion in patients with acute 
myelogenous leukemia.
II.  Determine the MTD of M-CSF given by continuous infusion for 14 days for 2 
courses, with a 14-day rest period between courses.
III.  Correlate in vivo effects of M-CSF with in vitro assays for 
differentiation.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 18 years of age 
with acute myelogenous leukemia (AML) that is refractory or in first or 
subsequent relapse including those with secondary AML; peripheral blasts must 
be less than 25,000/cumm.  At least 4 weeks must have elapsed since previous 
therapy (6 weeks since mitomycin and nitrosoureas), and patients must not have 
received prior treatment with the study agent (those previously treated on 
this protocol may be re-entered provided they have not developed antibodies to 
the study agent).  A Karnofsky performance status of at least 50% and a life 
expectancy greater than 8 weeks are required, as is adequate organ function 
defined as follows:  bilirubin less than 1.5 mg/dl and SGOT and SGPT no more 
than 2 x the upper limit of normal; creatinine less than 2.0 mg/dl and 
creatinine clearance at least 60 ml/min; NYHA classification II or better; and 
FVC, FEV1, and DLCO greater than 60% of predicted.  Patients must be free of 
uncontrolled or life-threatening infection and must not require treatment with 
steroids, aspirin, or nonsteroidal anti-inflammatory agents.  CNS metastases 
and leukemic meningitis exclude, as does a history of seizures or significant 
neurologic abnormalities.  Patients with any medical condition that, in the 
judgment of the investigator, is incompatible with protocol therapy are 
ineligible.  Pregnancy and lactation exclude, and fertile women must use 
adequate contraception.

Expected Enrollment

Approximately 30 patients will be entered in this multicenter trial.

Outline

Nonrandomized study.
Biological Response Modifier Therapy.  Recombinant Human Macrophage Colony 
Stimulating Factor (Genetics Institute), M-CSF.

Trial Contact Information

Trial Lead Organizations

Albert Einstein Cancer Center at Albert Einstein College of Medicine

Rasim Ahmet Gucalp, MD, Protocol chair		Ph: 718-904-2754