Leukemia Clinical Trial
Official title:
BMS CA180157: A Phase I Combination Study of Dasatinib Plus Vorinostat in Accelerated Phase, Chronic Phase Refractory to Second Line Therapy or Blast Crisis Chronic Myelogenous Leukemia (CML), and in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL)
RATIONALE: Dasatinib and vorinostat may stop the growth of cancer cells by blocking some of
the enzymes needed for cell growth. Giving dasatinib together with vorinostat may kill more
cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib when
given together with vorinostat in treating patients with accelerated phase or blastic phase
chronic myelogenous leukemia or acute lymphoblastic leukemia.
OBJECTIVES:
- To define the maximum tolerated dose of dasatinib and vorinostat in patients with
accelerated phase or blastic phase chronic myelogenous leukemia or Philadelphia
chromosome-positive acute lymphoblastic leukemia.
- To assess the toxicity of this regimen in these patients.
- To assess, preliminarily, the efficacy of this regimen in these patients.
Secondary
- To perform correlative studies relevant to this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib twice daily on days 1-21 and oral vorinostat twice daily on
days 1-14. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
Patients undergo bone marrow aspiration and blood sample collection periodically for
correlative laboratory studies. Samples are assessed by RT-PCR for DNA damage response and
proapoptotic elements (GADD45, FANC, and FOXO3A); cytogenetic analysis; flow cytometry;
mutation analysis of bcr-abl; and gene expression array analysis.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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