Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes

Phase 1/2 Completed 54 enrolled M.D. Anderson Cancer Center Eisai Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

Valproic acid is a medication that is currently used in the prevention of seizures, bipolar disorder, and migraine headaches. Researchers hope that it may improve the effects of decitabine. Decitabine is a chemotherapy drug with known activity in leukemia and myelodysplastic syndromes.

Timeline

Start: 2004-01-23
Primary completion: 2006-11-08
Completion: 2006-11-08

Publications

Garcia-Manero G, Kantarjian HM, Sanchez-Gonzalez B, Yang H, Rosner G, Verstovsek S, Rytting M, Wierda WG, Ravandi F, Koller C, Xiao L, Faderl S, Estrov Z, Cortes J, O'brien S, Estey E, Bueso-Ramos C, Fiorentino J, Jabbour E, Issa JP. Phase 1/2 study of the combination of 5-aza-2'-deoxycytidine with valproic acid in patients with leukemia. Blood. 2006 Nov 15;108(10):3271-9. doi: 10.1182/blood-2006-03-009142. Epub 2006 Aug 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Decitabine	Small molecule	15 mg/m2	Intravenous
Subject	Valproic Acid	Small molecule	20 mg/kg	Oral

Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes

Summary

Timeline

Publications

Drugs

Indications