A Phase II Study of Epigenetic Therapy With Hydralazine and Magnesium Valproate to Overcome Chemotherapy Resistance in Refractory Solid Tumors
Eligible patients after signing informed consent will undergo study evaluation and
acetylation status typing before being treated. Patients will begin treatment (day -7) with
a daily dose of a slow-release formulation of hydralazine tablets containing either 182 mg
for rapid-acetylators or 83 mg for slow-acetylators and slow-release tablets containing
700mg of magnesium valproate at a dose of 40mg/Kb t.i.d. Both hydralazine and magnesium
valproate will be administered from day -7 until the last day of the last chemotherapy
cycle. Chemotherapy will initiate at day 1 (after seven days of being taken hydralazine and
magnesium valproate) with the same pre-study protocol regimen at which patients showed tumor
progression. Toxicity will be evaluated after each course of chemotherapy. Response will be
evaluated at the third course of chemotherapy. Promoter of selected genes will be evaluated
by methylation-specific PCR in serum DNA before and after 7 days of treatment with
hydralazine and valproate.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical benefit (complete response, partial response and stable disease)
Alfonso Duenas-Gonzalez, MD PhD
Study Director
National Institute of Cancerologia
Mexico: Ethics Committee
005/32/DII
NCT00404508
September 2005
October 2006
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