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Clinical Trials (PDQ®)

Pilot Phase II Chemotherapy with Aclacinomycin-A in Adults with AML or ALL in Relapse

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosedover 18NCISWOG-8262

Objectives

I.  Determine the response rate and duration of response in adult patients 
with relapsed AML or ALL treated with aclacinomycin-A.
II.  Define the qualitative and quantitative toxicities of aclacinomycin-A in 
these patients.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Adults with a pathologically verified 
histologic diagnosis of AML or ALL who have relapsed after treatment on 
protocols of higher priority.  No more than two prior chemotherapeutic 
regimens may have been administered and patients must have had no prior 
treatment with the study agent.  Liver and kidney function must be adequate, 
and the performance status must be 3 or better.  Prior cumulative doses of 
adriamycin and daunomycin may not have exceeded 400 and 300 mg/sqm, 
respectively, unless cardiac function (as measured by nuclear scan) is normal. 
 There may be no history of congestive heart failure or ischemic heart disease 
and no current indication of an unstable cardiac status.

Expected Enrollment

25 evaluable patients with AML and 15 with ALL will be required.  Protocol 
closed December 1983 as it has accrued a sufficient number of patients to 
answer its objectives.

Outline

Nonrandomized study.
Induction and Consolidation:
Single-agent Chemotherapy.  Aclacinomycin-A, ACM, NSC-208734.

Published Results

Dabich L, Bull FE, Beltran G, et al.: Phase II evaluation of aclarubicin in refractory adult acute leukemia: a Southwest Oncology Group Study. Cancer Treat Rep 70 (8): 967-9, 1986.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Charles Coltman, MD, Protocol chair (Contact information may not be current)
Ph: 210-567-2710

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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