Vorinostat in Treating Patients With Acute Myeloid Leukemia
Adult Acute Erythroid Leukemia (M6), Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
About this trial
This is an interventional treatment trial for Adult Acute Erythroid Leukemia (M6)
Eligibility Criteria
Inclusion Criteria: 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 Fertile patients must use effective contraception No known HIV positivity More than 4 weeks since prior radiotherapy More than 2 weeks since prior valproic acid More than 3 weeks since other prior treatment for AML, including hematopoietic growth factors Hydroxyurea for WBC > 30,000/mm^3 allowed Recovered from prior therapy No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), epoetin alfa, or darbepoetin alfa No other concurrent investigational agents No other concurrent anticancer agents or therapies for this cancer
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (once daily vorinostat)
Arm II (thrice daily vorinostat)
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.
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.