Trials / Completed
CompletedNCT00357032
PXD101 in Treating Patients With Acute Myeloid Leukemia
A Phase 2 Study of PXD101 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia or Patients Over 60 With Newly-Diagnosed Acute Myelogenous Leukemia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory acute myeloid leukemia or older patients with newly diagnosed acute myeloid leukemia. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
Detailed description
PRIMARY OBJECTIVES: I. Evaluate the response rate (complete response and partial response) in patients with acute myeloid leukemia treated with PXD101. SECONDARY OBJECTIVES: I. Evaluate the overall survival of these patients. II. Evaluate the duration of response in these patients. III. Evaluate the toxicity of this drug in these patients. TERTIARY OBJECTIVES: I. Evaluate molecular response to PXD101. OUTLINE: Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity. Blood and bone marrow samples are obtained before and after study treatment for laboratory studies. After completion of study treatment, patients are followed periodically for 1 year.
Conditions
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Recurrent Adult Acute Myeloid Leukemia
- Untreated Adult Acute Myeloid Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | belinostat | Given IV |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2009-07-01
- Completion
- 2010-07-01
- First posted
- 2006-07-27
- Last updated
- 2018-04-17
- Results posted
- 2014-10-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00357032. Inclusion in this directory is not an endorsement.