drugset / Trial / NCT01130506

Decitabine, Vorinostat, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

NCT01130506

Phase 1 Completed 17 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and the best dose of cytarabine when given together with decitabine and vorinostat in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has returned or has not responded to treatment. Drugs used in chemotherapy, such as cytarabine and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cytarabine together with decitabine and vorinostat may kill more cancer cells.

Timeline

Start
2010-05-17
Primary completion
2012-11-19
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 1.5 g Intravenous
Subject Cytarabine Small molecule 3 g Intravenous
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Subject Vorinostat Small molecule 400 mg Oral