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

Head and Neck Cancer Clinical Trial

Official title:

Efficacy Evaluation of the Combination of Valproic Acid and Standard Platinum-based Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695122
• Other study ID #: 327/11
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2012
• Last updated: February 22, 2016
• Start date: September 2012
• Est. completion date: November 2014

Study information

• Verified date: February 2016
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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

Exclusion Criteria:

• Pregnancy

• Distant metastasis

• Hypersensibility to valproic acid or other antiepileptic drugs

• Valproic acid chronic use

• Severe neurologic impairment

• Uncontrolled comorbidity

• Hypoalbuminemia

• Known history of hepatitis B, C or HIV

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms
• Mouth Neoplasms
• Oral Cavity Cancer
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Drug:
• Valproic Acid

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de Sao Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers assessment			No
Primary	Response Rate	RECIST v 1.1	Within 6 to 8 weeks after completion of chemoradiation	No
Secondary	Adverse reactions to study treatment			Yes
Secondary	Progression free survival		Three years	No
Secondary	Overall survival		Three Years	No
Secondary	Response rate comparison by p16 status			No
Secondary	Quality of life			No