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	Closed	18 and over		YALE-HIC-3170 NCI-V86-0107

Objectives

I.  Determine the clinical usefulness of aclacinomycin-A as an inducer of cell 
differentiation in acute leukemia and myelodysplastic syndromes.

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 a histologically confirmed smoldering myeloid leukemic 
state--myelodysplastic syndrome ("preleukemia") as defined by the FAB 
Cooperative Group.  Elderly patients (greater than 65 years) with acute 
leukemia who refuse or who are undesirable candidates for aggressive leukemic 
induction chemotherapy (i.e., patients with concurrent non-leukemic illness in 
whom aggressive induction chemotherapy is not indicated, such as COPD, 
cirrhosis with portal hypertension, renal dysfunction not due to leukemic 
infiltrates, dementia) are also eligible, as are non-elderly patients with 
acute leukemia who refuse or who are undesirable candidates for aggressive 
leukemia induction chemotherapy (per January 1987 revision, these two groups 
of acute leukemia patients are now specifically excluded; the study is now 
open to acute leukemia patients who have relapsed after, or are refractory to, 
initial induction chemotherapy).  Patients with a myelodysplastic syndrome 
must have documented morphologic proof (from bone marrow aspirate smear or 
touch preps and marrow biopsy obtained within 21 days prior to entry) of one 
of the following types:  refractory anemia (RA); RA with ringed sideroblasts; 
RA with excess of blasts (RAEB); chronic myelomonocytic leukemia; or RAEB in 
transformation.  Patients with RA or RA with ringed sideroblasts must 
demonstrate involvement in at least two cell lines.  All myelodysplastic 
syndrome patients (except those with RAEB) must meet at least two of the 
following criteria:  documented transfusion requirement after a 3-month period 
of observation; platelet count of 100,000 cumm or less; or granulocyte count 
of 1,000/cumm or less.  Patients with RAEB must have at least one of the 
following:  transfusion requirement after 3 months of observation; platelet 
count of less than 100,000; or granulocyte count of less than 1,000.  A life 
expectancy of at least 2 months and an ECOG performance status of better than 
4 (better than 3, per January 1987 revision) are required.  Patients may have 
received prior chemotherapy, but no prior treatment with aclacinomycin-A is 
allowed.  Patients with significant cardiac disease (i.e., clinical CHF, 
uncontrolled cardiac arrhythmias, or myocardial infarction in the past 6 
months) are ineligible; a cardiac ejection fraction of at least 50% is 
required in those older than 50 years of age or those with a history of 
myocardial infarction or CHF or previous anthracycline exposure.  Patients who 
desire aggressive leukemia induction chemotherapy or who are potential 
candidates for bone marrow transplant are ineligible.  The presence of CNS 
leukemia excludes.

Expected Enrollment

10 patients/year will be entered over 2 years.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Aclacinomycin-A, ACM-A, NSC-208734.

Trial Contact Information

Trial Lead Organizations

Yale Cancer Center

Thomas Duffy, MD, Protocol chair		Ph: 203-785-4744

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