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

Information source: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head and Neck Cancer; Oral Cavity Cancer; Oropharyngeal Cancer

Intervention: Valproic Acid (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Instituto do Cancer do Estado de São Paulo

Official(s) and/or principal investigator(s):
Milena P Mak, MD, Principal Investigator, Affiliation: Instituto do Cancer do Estado de Sao Paulo - University of Sao Paulo

Summary

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.

Clinical Details

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

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

Primary outcome: Response Rate

Secondary outcome:

Adverse reactions to study treatment

Progression free survival

Overall survival

Response rate comparison by p16 status

Quality of life

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

Minimum age: N/A. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

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

Starting date: September 2012
Last updated: July 22, 2014

Page last updated: August 20, 2015

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