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Phase III Randomized Trial of Low-Dose ARA-C vs cis-Retinoic Acid in Preleukemia, ANLL, and CML
Basic Trial Information
Objectives I. Compare the antileukemic activities of cytosine arabinoside administered in daily low doses vs. cis-retinoic acid in patients with peripheral cytopenias resulting from myeloproliferative disorders. II. Examine the abilities of cytosine arabinoside and cis-retinoic acid to cause leukemic cells to differentiate. III. Assess toxicity associated with these regimens. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Adults who fall into one of the following categories: dysmyelopoietic syndrome (FAB criteria); patients with evolving secondary ANLL; elderly patients who are not candidates for intensive chemotherapy for ANLL; patients with refractory ANLL or CML after conventional therapy. Expected Enrollment Protocol closed June 1985. Outline Randomized study. Arm I: Single-agent Chemotherapy. Cytosine arabinoside, ARA-C, NSC-63878. Arm II: Single-agent Chemotherapy. cis-Retinoic acid. Trial Lead Organizations University of Chicago Cancer Research Center
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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