BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia

Completed · Phase 1

Conditions studied: Adult Acute Promyelocytic Leukemia (M3), Blastic Phase Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Excess Blasts in Transformation, Relapsing Chronic Myelogenous Leukemia

In brief

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

Key facts

Study ID: NCT00006213
Run by: National Cancer Institute (NCI)
People needed: 30
Starts: 2000-04-01
Last updated by the study team: 2013-01-23

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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