BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
Adult Acute Promyelocytic Leukemia (M3), Blastic Phase Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Adult Acute Promyelocytic Leukemia (M3)
Eligibility Criteria
Inclusion Criteria: Patients must have: AML, ALL, or high-risk MDS (RAEB or RAEB-t) that has: Not responded (no CR) to initial induction chemotherapy, or Recurred after an initial CR of < 1 year, or Recurred after an initial CR of > 1 year and failed to respond to an initial reinduction attempt, or Recurred more than once, or Chronic myeloid leukemia in myeloid blast phase Patients with CML blast phase may receive BMS-214662 as their first therapy for blast phase or after failing other treatments for blast phase Patients with refractory or relapsed acute promyelocytic leukemia are eligible provided they have failed an ATRA-containing regimen Performance status of =< 0-2 Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of the hospital Patients must have been off chemotherapy for the 4 weeks prior to entering this study and recovered from the toxic effects of that therapy; patients with evidence of rapidly progressive disease (i.e., absolute peripheral blood blast count >= 5 x 10^9/L and increasing by >= 1 x 10^9/L/24 hours) may receive treatment before 4 weeks from the previous treatment providing they have recovered from all toxic effects of that therapy; use of hydroxyurea on patients with rapidly proliferative disease is allowed up to 24 hours prior to the start of therapy Bilirubin =< 1.5 mg/dL Creatinine =< 1.5 mg/dL or creatinine clearance >= 60 mL/hr Patients who are likely to benefit from allogeneic bone marrow transplantation (i.e., age < 60 years of physiological age with histocompatible donor) should be excluded from this study unless such therapy is not feasible Exclusion Criteria: Pregnant and nursing females will be excluded; patients of childbearing potential should practice effective methods of contraception Patients with prolonged QTc interval on EKG are excluded
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (BMS-214662)
Patients receive BMS-214662 IV over 1 hour weekly for 4 weeks. Treatment continues every 4 weeks for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.