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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Milena Mak, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT01695122
First received: September 25, 2012
Last updated: July 22, 2014
Last verified: July 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Instituto do Cancer do Estado de São Paulo:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Within 6 to 8 weeks after completion of chemoradiation ] [ Designated as safety issue: No ]
    RECIST v 1.1


Secondary Outcome Measures:
  • Adverse reactions to study treatment [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: Three years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Three Years ] [ Designated as safety issue: No ]
  • Response rate comparison by p16 status [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]

Other Outcome Measures:
  • Biomarkers assessment [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Primary Completion Date: September 2016 (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

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 25, 2012
Last Updated: July 22, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by 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
Mouth Neoplasms
Oropharyngeal Neoplasms
Carcinoma
Mouth Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases
Valproic Acid
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014