BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop
 growing or die. Phase I trial to study the effectiveness of BMS-214662 in treating patients
 who have acute leukemia, myelodysplastic syndrome, or chronic myeloid leukemia in blast phase
PRIMARY OBJECTIVES:

 I. Determine the maximum tolerated dose and dose limiting toxicity of BMS-214662 in patients
 with acute leukemia, myelodysplastic syndrome, or chronic myeloid leukemia in blast phase.

 II. Determine any preliminary evidence of antileukemia activity of this drug in these
 patients.

 OUTLINE: This is a dose escalation study.

 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.

 Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated
 dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
 patients experience dose limiting toxicities.

 PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 10 months.
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