Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 2 Study of Suberoylanilide Hydroxamic Acid (SAHA) in Acute Myeloid Leukemia (AML)
Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for their growth. Giving the drug in different ways may kill more cancer cells. This randomized phase II trial is studying two different schedules of vorinostat to see how well they work in treating patients with acute myeloid leukemia.
PRIMARY OBJECTIVES:
I. Determine the toxicity and the proportion of complete remissions associated with two
different treatment schedules of vorinostat (SAHA) in patients with acute myeloid leukemia.
SECONDARY OBJECTIVES:
I. Determine the toxic effects of SAHA in this study population. II. Examine for preliminary
evidence of re-expression of silenced genes in leukemic blasts in response to SAHA.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
disease status (relapsed vs untreated). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral vorinostat (SAHA) once a day on days 1-21. In both arms,
treatment repeats every 21 days for up to 17 courses in the absence of disease progression
or unacceptable toxicity.
ARM II: Patients receive oral SAHA three times a day on days 1-14. In both arms, treatment
repeats every 21 days for up to 17 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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