| Exclusion Criteria: | 1) Diagnosis of acute promyelocytic leukemia;
2) Active, uncontrolled, systemic infection considered opportunistic, life threatening or clinical significant at the time of treatment, or any severe concurrent disease, which in the opinion of the investigator and after discussion with the principal investigator, would make the patient inappropriate for study entry;
3) Male and female patients who are fertile agree to use an effective barrier method of birth control (i.e., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if patient of childbearing potential. Non childbearing is defined as 1 year or more postmenopausal or surgically sterilized);
4) Symptomatic CNS involvement;
5) Patient is unable to take and/or tolerate oral medications on a continuous basis;
6) Patient has known human immunodeficiency virus (HIV) infection or known HIV-related malignancy;
7) Patient has active hepatitis B or C infection. Active disease is defined as elevated liver enzymes and/or clinical symptoms of hepatitis in addition to positive blood test for hepatitis surface antigen. In the absence of elevated liver enzymes and/or clinical symptoms, the blood test for hepatitis core antigens is not required.
8) Patient is pregnant or breast-feeding;
9) Patient has a known allergy or hypersensitivity to any component of vorinostat;
10) Patient has a history of thrombotic disorders;
11) History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent.
12) Diagnosis of acute promyelocytic leukemia. Flt-3 extension phase.
13) Active, uncontrolled, systemic infection considered opportunistic, life threatening or clinical significant at the time of treatment, or any severe concurrent disease, which in the opinion of the investigator and after discussion with the principal investigator, would make the patient inappropriate for study entry. Flt-3 extension phase.
14) Male and female patients who are fertile agree to use an effective barrier method of birth control (i.e., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if patient of childbearing potential. Non childbearing is defined as 1 year or more postmenopausal or surgically sterilized). Flt-3 extension phase.
15) Symptomatic CNS involvement. Flt-3 extension phase.
16) Patient is unable to take and/or tolerate oral medications on a continuous basis. Flt-3 extension phase.
17) Patient has known human immunodeficiency virus (HIV) infection or known HIV-related malignancy. Flt-3 extension phase.
18) Patient has active hepatitis B or C infection. Active disease is defined as elevated liver enzymes and/or clinical symptoms of hepatitis in addition to positive blood test for hepatitis surface antigen. In the absence of elevated liver enzymes and/or clinical symptoms, the blood test for hepatitis core antigens is not required. Flt-3 extension phase.
19) Patient is pregnant or breast-feeding. Flt-3 extension phase.
20) Patient has a known allergy or hypersensitivity to any component of vorinostat. Flt-3 extension phase.
21) Patient has a history of thrombotic disorders. Flt-3 extension phase.
22) History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent. Flt-3 extension phase. |