Expired Study
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Houston, Texas 77030


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00006213


Primary Contact:

Principal Investigator
Jorge Cortes
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 17, 2017

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