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


Phase 2
N/A
60 Years
Open (Enrolling)
Both
Head and Neck Cancer, Oral Cavity Cancer, Oropharyngeal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response Rate

Outcome Description:

RECIST v 1.1

Outcome Time Frame:

Within 6 to 8 weeks after completion of chemoradiation

Safety Issue:

No

Principal Investigator

Milena P Mak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto do Cancer do Estado de Sao Paulo - University of Sao Paulo

Authority:

Brazil: Ethics Committee

Study ID:

327/11

NCT ID:

NCT01695122

Start Date:

September 2012

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Oral Cavity Cancer
  • Oropharyngeal Cancer
  • Head and Neck Cancer
  • Oropharyngeal cancer
  • Oral cavity cancer
  • Chemoradiation
  • valproic acid
  • histone deacetylase
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Mouth Neoplasms
  • Oropharyngeal Neoplasms

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