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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01695122
First Posted: September 27, 2012
Last Update Posted: February 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Milena Mak, Instituto do Cancer do Estado de São Paulo
  Purpose
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.

Condition Intervention Phase
Head and Neck Cancer Oral Cavity Cancer Oropharyngeal Cancer Drug: Valproic Acid Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Milena Mak, Instituto do Cancer do Estado de São Paulo:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Within 6 to 8 weeks after completion of chemoradiation ]
    RECIST v 1.1


Secondary Outcome 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

Other Outcome Measures:
  • Biomarkers assessment

Enrollment: 14
Study Start Date: September 2012
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: valproic acid Drug: Valproic Acid
Other Name: sodium valproate

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695122


Locations
Brazil
Instituto do Cancer do Estado de Sao Paulo
Sao Paulo, SP, Brazil, 05409-011
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
University of Sao Paulo
Investigators
Principal Investigator: Milena P Mak, MD Instituto do Cancer do Estado de Sao Paulo - University of Sao Paulo
  More Information

Responsible Party: Milena Mak, MD, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01695122     History of Changes
Other Study ID Numbers: 327/11
First Submitted: September 25, 2012
First Posted: September 27, 2012
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Milena Mak, Instituto do Cancer do Estado de São Paulo:
Head and Neck Cancer
Oropharyngeal cancer
Oral cavity cancer
Chemoradiation
valproic acid
histone deacetylase

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Mouth Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Mouth Diseases
Valproic Acid
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs