Vorinostat in Treating Patients With Acute Myeloid Leukemia
Completed · Phase 2
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT00305773
- Run by
- National Cancer Institute (NCI)
- People needed
- 37
- Starts
- 2006-01-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2014-05-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of acute myeloid leukemia (AML), meeting 1 of the following criteria:
- Relapsed AML in the following categories:
- Good-risk cytogenetics [inv(16), t (8;21)] in second relapse or in first relapse following a remission of < 12 months
- Acute promyelocytic leukemia (M3) in second relapse or greater AND must have relapsed following both tretinoin-anthracycline-based therapy and arsenic trioxide-based therapy
- All other relapsed patients are eligible
- Untreated AML in the following categories:
- At least 65 years of age
- Myelodysplastic syndromes-AML (AML with trilineage dysplasia)
- AML with del5Q or monosomy 5, monosomy 7, or complex cytogenetics (≥ 3 cytogenetic abnormalities)
- Refused or ineligible for potentially curative options such as allogeneic stem cell transplantation
- No clinical evidence of CNS or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia
- ECOG performance status (PS) 0-2 or Karnofsky PS ≥ 60%
- Life expectancy ≥ 3 months
- Bilirubin normal unless attributed to hemolysis or Gilbert's disease in the opinion of the investigator
- AST/ALT ≤ 2.5 times upper limit of normal (ULN)
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat
- No uncontrolled intercurrent illness, including any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would limit compliance with study requirements
- Not pregnant or nursing
- Negative pregnancy test
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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