Vorinostat in Treating Patients With Acute Myeloid Leukemia
Condition: 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
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Promyelocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Erythroblastic, Acute
Intervention: vorinostat; vorinostat
Intervention description: Given orally once daily; Given orally three times daily
Intervention MeSH terms: Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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