A Phase I Study of 5-AZA-2'-Deoxycytidine and Depsipeptide in Patients With Relapsed/Refractory Leukemia, Myelodysplastic Syndromes, or Myeloproliferative Disease
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and recommended phase II dose of decitabine and
FR901228 (depsipeptide) in patients with relapsed or refractory leukemia, myelodysplastic
syndromes, or myeloproliferative disease.
II. Determine the safety and tolerability of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Determine the clinical activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive decitabine IV over 1 hour on days 1-5 and 8-12 and FR901228 (depsipeptide)
IV over 4 hours on days 5 and 12 OR days 5, 12, and 19. Treatment repeats every 4-6 weeks
for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients experiencing complete remission for 1 year are removed from the study.
Cohorts of 6 patients receive escalating doses of decitabine and FR901228 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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity at 6 weeks after each course
Yes
Jean-Pierre Issa, MD
Study Chair
M.D. Anderson Cancer Center
United States: Food and Drug Administration
NCI-2012-02657
NCT00114257
May 2005
Name | Location |
---|---|
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |