Phase I Trial of Vorinostat (MK-0683, SAHA) in Combination With Decitabine in Patients With AML or MDS (MK-0683-055 EXT1)

This is an interventional treatment trial for Leukemia, Myelocytic, Acute Myelodysplastic Syndromes focused on measuring Leukemia, Myelocytic, Acute Myelodysplastic Syndromes Read More

Inclusion Criteria:

• Patient is at least 18 years old with refractory/relapsed AML

  • If untreated AML, patient is older than 60 years old and not a candidate for standard chemotherapy
• Patient is at least 4 weeks from prior treatment and has recovered from all prior treatment side effects
• Patient has no known liver or kidney problems
• Patient knows of no reason they can not receive transfusions of blood clotting cells (platelets)
• Patient is able to swallow capsules
• Patients both male and female are willing to practice birth control during the study

Exclusion Criteria:

• Patient has received prior treatment with valproic acid, decitabine or azacitidine
• Being is less than 18 years of age or if patient has untreated AML is below 60 years of age
• Patient is a women who is pregnant or breastfeeding. Patient has an active infection that requires antibiotics
• Patient has uncontrolled illness including but not limited to the following: heart problems (congestive heart failure, unstable angina pectoris, cardiac arrhythmia), inflammation of the pancreas; a mental or social condition that may interfere with patient following study procedures
• Patient has known human immunodeficiency virus (HIV) infection or HIV-related malignancy. Patient has a known history of hepatitis B or C infection
• Patient currently has another active cancer other than certain types of skin cancer
• Patient is heterosexual and able to have a child and is unwilling to practice birth control during the study