Trials / Completed
CompletedNCT00024180
FR901228 in Treating Patients With Hematologic Cancer
A Phase I Study of Depsipeptide in Selected Hematologic Malignancies (NSC 630176)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Ohio State University Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 FR901228 in treating patients who have hematologic cancer.
Detailed description
OBJECTIVES: * Determine the in vivo biologic effect of FR901228 (depsipeptide) in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, acute myeloid leukemia, or acute lymphoblastic leukemia. * Determine the pharmacokinetics and cellular pharmacodynamics of this drug in these patients. * Determine any preliminary anti-tumor activity of this drug in these patients. OUTLINE: This is a dose-decreasing, multicenter study. Patients are stratified according to disease (chronic lymphocytic leukemia and small lymphocytic lymphoma vs acute myeloid leukemia and acute lymphoblastic leukemia). Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Cohorts of 10 patients per stratum receive decreasing doses of FR901228 until the minimal active dose is determined. If 5 or more patients show clinical or biological response, the subsequent cohort is treated at a lower dose. If fewer than 5 patients respond, the subsequent cohort is treated at a higher dose. PROJECTED ACCRUAL: A minimum of 20 patients (10 per stratum) will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | romidepsin |
Timeline
- Start date
- 2002-01-01
- Completion
- 2006-08-01
- First posted
- 2003-01-27
- Last updated
- 2013-01-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00024180. Inclusion in this directory is not an endorsement.