drugset / Trial / NCT00079378

Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT00079378

Phase 1 Completed 84 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with refractory or relapsed acute myeloid leukemia or previously treated chronic lymphocytic leukemia or small lymphocytic leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Valproic acid may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Combining decitabine with valproic acid may kill more cancer cells.

Timeline

Start
2004-02
Primary completion
2011-05
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Subject Valproic Acid Small molecule 20 mg/kg Oral
Subject Valproic Acid Small molecule 25 mg/kg Oral