Phase I Trial of Vorinostat (SAHA) in Combination With Alvocidib (Flavopiridol) in Patients With Relapsed, Refractory, or (Selected) Poor Prognosis Acute Leukemia or Refractory Anemia With Excess Blasts-2
I. Determine recommended phase II doses for the combination of flavopiridol and vorinostat
in patients with acute leukemia, chronic myelogenous leukemia in blast crisis, or refractory
anemia with excess blasts-2.
I. Determine the safety, toxicity, tolerability, and maximum tolerated dose of this drug
II. Determine the pharmacodynamic and clinical anti-leukemic effects of this drug regimen.
III. Correlate leukemia gene expression patterns with response in patients treated with this
OUTLINE: This is an open-label, dose-escalation study of flavopiridol.
Patients receive flavopiridol IV over 1 hour on days 1-5 and oral vorinostat three times
daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or
Cohorts of 3-6 patients receive escalating doses of flavopiridol 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 toxicity.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD for the combination of alvocidib and vorinostat, assessed by Common Toxicity Criteria version 3.0
Massey Cancer Center
United States: Food and Drug Administration
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