Flavopiridol and Vorinostat in Treating Patients With Relapsed or Refractory Acute Leukemia or Chronic Myelogenous Leukemia or Refractory Anemia
Blastic Phase Chronic Myelogenous Leukemia
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Refractory Anemia With Excess Blasts
Relapsing Chronic Myelogenous Leukemia
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Adult Acute Myeloid Leukemia
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- MTD for the combination of alvocidib and vorinostat, assessed by Common Toxicity Criteria version 3.0 [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2006|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients will receive a 1-hour infusion of flavopiridol on 5 days in week 1 and vorinostat by mouth three times a day in weeks 1 and 2. Treatment may repeat every 3 weeks for as long as benefit is shown.
Given by infusion
Other Names:Drug: vorinostat
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 regimen.
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 regimen.
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 unacceptable toxicity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278330
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Steven Grant||Massey Cancer Center|