Leukemia Clinical Trial
Official title:
Phase I Clinical-Labratory Study of the Histone Deacetylase (HDA) Inhibitor MS-275 in Adults With Refractory and Relapsed Hematologic Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of MS-275 in treating patients who have
hematologic cancer.
OBJECTIVES:
- Determine the toxic effects and pharmacokinetics of MS-275 in patients with poor-risk
hematologic malignancy.
- Determine whether this drug induces changes in hematologic differentiation, in terms of
changes in morphology, cell surface marker expression, and acetylation status, in these
patients.
- Determine whether this drug induces clinical response in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral MS-275 on days 1, 8, 15, and 22. Courses repeat every 6 weeks in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of MS-275 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3
or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
;
Primary Purpose: Treatment
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