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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2014

Detailed 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.

Interventions

  • Drug: Valproic Acid

Arms, Groups and Cohorts

  • Experimental: valproic acid

Clinical Trial Outcome Measures

Primary Measures

  • Response Rate
    • Time Frame: Within 6 to 8 weeks after completion of chemoradiation
    • RECIST v 1.1

Secondary Measures

  • Adverse reactions to study treatment
  • Progression free survival
    • Time Frame: Three years
  • Overall survival
    • Time Frame: Three Years
  • Response rate comparison by p16 status
  • Quality of life

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto do Cancer do Estado de São Paulo
  • Collaborator
    • University of Sao Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Milena Mak, MD – Instituto do Cancer do Estado de São Paulo
  • Overall Official(s)
    • Milena P Mak, MD, Principal Investigator, Instituto do Cancer do Estado de Sao Paulo – University of Sao Paulo

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