A Phase 2 Study of Temozolomide Plus Vorinostat for Elderly Patients (>60) With Newly Diagnosed Acute Myeloid Leukemia (AML) or Relapse/Refractory AML
The purpose of the study is to first determine if Temozolomide plus Vorinostat in combination can control relapsed or refractory AML and determine if this combination can be safely taken. The study will look at the side effects of the Temozolomide plus Vorinostat in combination and whether the treatment schedule is tolerated.
- drug : Temozolomide
Phase: Phase 2
Ages Eligible For Study:
- Female patient of childbearing potential has a negative serum pregnancy test beta-hCG within 72 hours prior to receiving the first dose of vorinostat. - Female patient is either post menopausal, free from menses for > 2 years, surgically sterilized or willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from heterosexual activity throughout the study, starting with Visit 1. - Male patient agrees to use an adequate method of contraception for the duration of the study and 1 month following coming off study or of study completion. - Patient, or the patient's legal representative, has voluntarily agreed to participate by giving written informed consent. - Patient is >=18 years of age on day of signing informed consent. - Patient is available for periodic blood sampling, study related assessments, and management at the treating institution for the duration of the study.