Trials / Completed
CompletedNCT00305773
Vorinostat in Treating Patients With Acute Myeloid Leukemia
A Phase 2 Study of Suberoylanilide Hydroxamic Acid (SAHA) in Acute Myeloid Leukemia (AML)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for their growth. Giving the drug in different ways may kill more cancer cells. This randomized phase II trial is studying two different schedules of vorinostat to see how well they work in treating patients with acute myeloid leukemia.
Detailed description
PRIMARY OBJECTIVES: I. Determine the toxicity and the proportion of complete remissions associated with two different treatment schedules of vorinostat (SAHA) in patients with acute myeloid leukemia. SECONDARY OBJECTIVES: I. Determine the toxic effects of SAHA in this study population. II. Examine for preliminary evidence of re-expression of silenced genes in leukemic blasts in response to SAHA. OUTLINE: This is a multicenter, randomized study. Patients are stratified according to disease status (relapsed vs untreated). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral vorinostat (SAHA) once a day on days 1-21. In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive oral SAHA three times a day on days 1-14. In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 2 years. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Conditions
- Adult Acute Erythroid Leukemia (M6)
- Adult Acute Megakaryoblastic Leukemia (M7)
- Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
- Adult Acute Monoblastic Leukemia (M5a)
- Adult Acute Monocytic Leukemia (M5b)
- Adult Acute Myeloblastic Leukemia With Maturation (M2)
- Adult Acute Myeloblastic Leukemia Without Maturation (M1)
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- 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)
- Adult Acute Myelomonocytic Leukemia (M4)
- Adult Acute Promyelocytic Leukemia (M3)
- Recurrent Adult Acute Myeloid Leukemia
- Refractory Cytopenia With Multilineage Dysplasia
- Secondary Acute Myeloid Leukemia
- Untreated Adult Acute Myeloid Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | vorinostat | Given orally once daily |
| DRUG | vorinostat | Given orally three times daily |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2009-05-01
- Completion
- 2010-01-01
- First posted
- 2006-03-22
- Last updated
- 2014-05-19
- Results posted
- 2013-05-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00305773. Inclusion in this directory is not an endorsement.