Valproic Acid and Platinum-based Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma

Instituto do Cancer do Estado de São Paulo

Status and phase

Completed

Phase 2

Conditions

Oropharyngeal Cancer

Oral Cavity Cancer

Head and Neck Cancer

Treatments

Drug: Valproic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01695122

327/11

Details and patient eligibility

About

The purpose of this study is to evaluate if the addition of valproic acid to standard platinum-based chemoradiation as definitive treatment of locally advanced Head and Neck squamous cell carcinoma can improve treatment outcomes, such as response rate.

Full description

Valproic acid is a known histone deacetylase inhibitor. In addition to activating apoptosis pathways, cell differentiation and downregulating expression of growth factors, it also promotes radiosensitization.

Most patients with Head and Neck squamous cell carcinoma are diagnosed with locally advanced disease, in which long term disease control is still a challenge. The incorporation of epigenetic regulation into standard treatment could improve results of definitive platinum-based chemoradiation in such patients.

Enrollment

14 patients

Sex

All

Ages

Under 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Unresectable Oropharyngeal or oral cavity squamous cell carcinoma
Candidate for definitive chemoradiation
No previous treatment
Measurable disease according to RECIST v 1.1
Previous neoplasia, other than Head and Neck, with more than five years without evidence of disease; basocellular carcinoma of the skin and in situ cervical dysplasia if resected
Age under 60 years
ECOG performance status 0-2
Ability of understanding and giving informed consent
Adequate renal and hepatic function
Adequate bone marrow function
Normal serum magnesium
Absence of QTc prolongation
Life expectancy of over 12 weeks