Status:
COMPLETED
A Phase II Study of Epigenetic Therapy to Overcome Chemotherapy Resistance in Refractory Solid Tumors
Lead Sponsor:
National Institute of Cancerología
Collaborating Sponsors:
Psicofarma, S.A. De C.V.
National Council of Science and Technology, Mexico
Conditions:
Refractory Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 coul...
Detailed Description
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-re...
Eligibility Criteria
Inclusion
- Aged18 years and older.
- Histologically proven malignant solid tumors who were receiving their second, third or fourth line of palliative chemotherapy and who showed at the second or third course progressive disease as their maximum response according to the RECIST criteria or to the IGCG CA125 criteria in case of ovarian cancer patients.
- Measurable disease defined by 1 of the following criteria: Any unidimensional measurable lesion ≥ 10 mm by standard MRI or CT scan for solid tumors; or at least 1 non-measurable lesion that is evaluable by nuclear medicine, tumor markers, or other reliable measures.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2; Absolute leukocyte count (≥4000/mm3), platelets ≥100,000/mm3, hemoglobin ≥9.0 g/dL; total bilirubin, aspartate amino transferase (AST) and alanine amino transferase (ALT) \<1.5 the upper normal limit (UNL), creatinine ≤1.2 mg/dL or a calculated creatinine clearance of ≥60 mL/min.
- Life expectancy of more than three months,
- Written informed consent.
Exclusion
- History of allergy to hydralazine or valproate.
- Past or present condition of rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician.
- Previous use of the experimental drugs (hydralazine and magnesium valproate)
- Pregnancy or breast-feeding.
- Uncontrolled systemic disease or infection.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00404508
Start Date
September 1 2005
End Date
October 1 2006
Last Update
November 28 2006
Active Locations (1)
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1
National Institute of Cancerologia
Mexico City, Tlalpan, Mexico, 14080