A Phase II Study of Epigenetic Therapy to Overcome Chemotherapy Resistance in Refractory Solid Tumors
Status:
Completed
Trial end date:
2006-10-01
Target enrollment:
Participant gender:
Summary
Chemotherapy resistance, either innate or acquired requires for its development, expression
changes on a large number of genes therefore, it has been hypothesized that
epigenetic-mediated changes could be the responsible driving force for chemotherapy
resistance. Aberrant DNA methylation and histone deacetylation are the main epigenetic
alterations hence, their reversal by inhibitors of DNA methylation and histone deacetylases
(HDACs) may overcome resistance in refractory solid tumors.
Patients will be treated with hydralazine and magnesium valproate starting from day -7 until
chemotherapy ends which consists on the same pre-study protocol regimen on which patients
progressed. Response and toxicity were evaluated. Global DNA methylation and HDAC activity
were evaluated in the peripheral blood cells, as well as the plasma levels of valproic acid
and hydralazine.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Cancerología
Collaborators:
National Council of Science and Technology, Mexico Psicofarma S.A. de C.V.