Cervical Cancer Clinical Trial
Official title:
A Phase II Study of Transcriptional Therapy With the DNA Demethylating Hydralazine and the HDAC Inhibitor Valproate Associated to Concomitant Cisplatin Chemoradiation in FIGO Stage III Cervical Cancer.
The current standard for locally advanced cervical cancer is concurrent cisplatin-based
chemotherapy, however, the treatment results need to be improved. Epigenetic aberrations
play an important role in cancer progression by silencing growth regulatory genes and there
is now evidence that inhibitors of DNA methylation and HDAC inhibition synergize the
radiation and chemotherapy effects.
Objective. To determine response rate, safety and biological effects of hydralazine and
magnesium valproate when added to cisplatin chemoradiation.
Hypothesis. Hydralazine and magnesium valproate associated to chemoradiation will increase
the clinical complete response rate to 95% as compared to 75% as seen in historical controls
treated with cisplatin chemoradiation in FIGO stage IIIB patients.
Metodology. A total of 17 FIGO stage IIIB patients with histologically confirmed cervical
carcinoma with no previous treatment will be included. Patients will be typed for acetylator
status and and then receive either 182 or 83 mg of hydralazine, and magnesium valproate at
40mg/Kg from day -7 to the end of chemoradiation (external and brachytherapy). Clinical
response rate, safety and transcriptome changes will be analyzed.
Eligible patients after signing informed consent will undergo study evaluation and then
typed for acetylator phenotype before receive either 182 or 83 mg of hydralazine, and
magnesium valproate at 30mg/Kg from day -7 to the end of chemoradiation (external and
brachytherapy. External beam radiation will be delivered by megavoltage equipment for a dose
of 50gy (2Gy fraction from monday to friday) concurrently with cisplatin at 40mg/m2 for six
weeks. Within one to two weeks, intracavitary brachytherapy (low-dose rate, Cesium sources)
will be delivered to achieve at least 85Gy to point A. A punch biopsy from the primary tumor
will be taken at entering the study and at day 8 of hydralazine and valproate treatment
(before the first dose of cisplatin and radiation)to assess global gene expression profiling
by microarray analysis. Blood samples will be taken to assess global DNA methylation,
histone deacetylase activity and plasma levels of hydralazine and valproic acid.
Clinical response and toxicity will be assessed.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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