Phase II Study of Subcutaneous Azacytidine in Patients with Myelodysplastic Syndromes
Basic Trial Information
|Phase II||Treatment||Completed||over 15||NCI||CLB-8921|
I. Determine which myelodysplastic syndromes respond optimally to subcutaneous azacytidine (AZA). II. Evaluate the toxicity of subcutaneous AZA in patients with certain myelodysplastic syndromes.
See General Eligibility Criteria
See General Eligibility Criteria
General Eligibility Criteria:
Patients over 15 years of age with an established diagnosis of myelodysplastic syndrome that is confirmed by erythroid, megakaryocytic, and granulocytic maturational abnormalities in peripheral blood and bone marrow conforming to one of the following categories: refractory anemia with excess blasts (RAEB), defined as 5-20% myeloblasts in bone marrow and less than 5% blasts in peripheral blood; RAEB in transformation (RAEB-T), defined as 21-30% myeloblasts in bone marrow, more than 5% blasts in peripheral blood, or Auer rods in granulocytic precursors in marrow or blood and no more than 30% myeloblasts in marrow; or chronic myelomonocytic leukemia (CMML), defined as an absolute monocytosis of more than 1 x 10 to the ninth cells/liter with less than 5% blasts in peripheral blood and no more than 20% blasts in bone marrow. (At least 200 cells are required for bone marrow differential determinations.) Patients with more than 30% myeloblasts in the bone marrow are ineligible. No prior cytotoxic therapy for this disease is allowed, nor is prior treatment with azacytidine. At least 6 months must have elapsed since any prior radiotherapy or chemotherapy for cancer, during which time the patient must have been free of any evidence of malignancy. A performance status of 2 or better and a life expectancy of at least 2 months are required, as are the following laboratory values (obtained within 2 weeks of registration): total bilirubin no more than 1.5 times normal (unless the patient has active hemolysis or the elevation is secondary to ineffective erythropoiesis) and SGOT/SGPT no more than twice normal; serum creatinine no more than 1.5 times normal; and serum CO2 greater than 19 mEq/liter. The following conditions exclude: uncontrolled or severe congestive heart failure; any other serious medical or psychiatric illness that would limit survival to less than 2 years or prevent informed consent; and pregnancy. Patients must be able to begin protocol therapy within 2 weeks of completing prestudy requirements.
50 patients will be entered. It is expected that the study will be completed in less than 1.5 years.
Nonrandomized study. Single-Agent Chemotherapy. Azacytidine, AZA, NSC-102816.
Silverman LR, McKenzie DR, Peterson BL, et al.: Further analysis of trials with azacitidine in patients with myelodysplastic syndrome: studies 8421, 8921, and 9221 by the Cancer and Leukemia Group B. J Clin Oncol 24 (24): 3895-903, 2006.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Cancer and Leukemia Group B
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.