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 Closed over 15 NCI CORN-8402 NCI-T84-0208W, T84-0208

Objectives

I.  Outline the procedure for Phase I studies to evaluate the antileukemic 
activity of new single agents in the treatment of refractory/relapsed adult 
acute myelocytic leukemia.
II.  Determine the maximum tolerated dose of the agent tested.
III.  Determine the toxicity (predictability, reversibility, and means of 
prevention) of the agent.
IV.  Determine the pharmacokinetics (i.e., serum half-lives, peak 
concentration, metabolism, disposition, body fluid and cellular concentration, 
absorption) of the agent tested so that a more rational schedule may be 
developed.
V.  Evaluate the efficacy of the agents tested.
VI.  Evaluate 4'-deoxydoxorubicin in this portion of the master protocol.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients older than 15 years of age 
with a diagnosis of acute myelocytic leukemia (confirmed by FAB classification 
system using bone marrow aspirate or biopsy) including:  acute myeloblastic 
leukemia (M1-4), acute monocytic leukemia (M5), and acute erythroleukemia 
(M6).  Those with acute lymphoblastic leukemia (by FAB:  L1, L2, L3) or 
blastic phase of chronic myelogenous leukemia are also eligible.  Patients 
must have progressive leukemia refractory to known effective induction therapy 
as defined by a bone marrow with greater than 30% leukemic cells (M3 or M4) or 
marrow reinfiltration by 25% leukemic elements (in patients who had previously 
reached M1) and signs of bone marrow failure such as anemia, granulocytopenia, 
or thrombocytopenia.  At least 2 weeks must have elapsed since prior 
chemotherapy or radiotherapy; there must be full recovery from the effects of 
such therapy.  There may have been no prior therapy with the agent(s) to be 
studied.  A CALGB performance status of 3 or better, a life expectancy of more 
than 8 weeks, and adequate renal and hepatic function are required.  Patients 
with a history of inflammatory bowel disease are ineligible if any of the 
study agents have shown marked GI toxicity in Phase I evaluation; those with a 
history of congestive heart failure, who have demonstrated angina, or who have 
had a myocardial infarction within 6 months of entry are ineligible if any of 
the study agents have shown cardiac toxicity in Phase I evaluation.  Pregnancy 
excludes.

Expected Enrollment

3 patients will be entered at each dose level if no toxicity is seen.  With 
the advent of toxicity at a given level, a minimum of 6-8 patients will be 
entered at that level as long as the MTD is not reached.  If the MTD is 
reached, only 3 patients will be entered.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  4'-Deoxydoxorubicin, DxDx, NSC-267469.

Trial Contact Information

Trial Lead Organizations

CCOP - North Shore University Hospital

Willi Kreis, MD, PhD, Protocol chair		Ph: 516-562-8906