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

February 22, 2016 updated by: Milena Mak, Instituto do Cancer do Estado de São Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05409-011
        • Instituto do Cancer do Estado de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: valproic acid
Drug: Valproic Acid
Other Names:
  • sodium valproate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Biomarkers assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Collaborators

University of Sao Paulo

Investigators

  • Principal Investigator: Milena P Mak, MD, Instituto do Cancer do Estado de Sao Paulo - University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

September 25, 2012

First Posted (Estimate)

September 27, 2012

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 327/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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