Cytarabine and UCN-01 in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, previously treated myelodysplastic syndromes, childhood myelodysplastic syndromes, Ara-C, Cytosar, DepoCyt, Cytosine arabinosine hydrochloride, cytarabine, 7-hydroxystaurosporine, UCN-01
Eligibility Criteria
Inclusion Criteria: 1. Patients with refractory or relapsed acute myelogenous leukemia, or myelodysplastic syndromes (RAEB or RAEB-T). 2. Performance status of =< 2 3. Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol for each participating institution. 4. Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. 5. Bilirubin and creatinine (or creatinine clearance) should be within institutional normal limits. 6. Patients must have relapsed or failed to respond after high-dose ara-C-based (>=1g/m2/day x 3 days) chemotherapy. 7. Corrected DLCO >50%. 8. Patients with >=3 cardiac risk factors (smoking, hypertension, family history of coronary artery disease, diabetes mellitus, hypercholesterolemia) should have a nuclear medicine stress test. Exclusion Criteria: 1. The anti-proliferative activity of the experimental drug may be harmful to the developing fetus or nursing infant. Therefore, pregnant and nursing females will be excluded. Patients of childbearing potential should practice effective methods of contraception. 2. Patients who are eligible for allogeneic marrow transplant and who have a donor will be offered transplant. 3. Patients with existing pulmonary diseases, history of coronary artery disease or who have received radiotherapy to the mediastinum.
Sites / Locations
- Arthur G. James Cancer Hospital - Ohio State University
- University of Texas - MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Cytarabine + UCN-01