Window Trial 5-aza in HNSCC, T-tare
Conditions
Head and Neck Squamous Cell Carcinoma
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Conditions: Keywords
HNSCC
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: 5-Azacitadine
Type: Drug
Overall Status
Not yet recruiting
Summary
The purpose of this study is to assess the activity of 5-azacitidine in patients with Human Papilloma Virus (HPV)-positive and HPV- negative head and neck squamous cell carcinoma (HNSCC). The response activity will be determined by analyzing your tumor tissue prior to and after treatment with 5-azacitidine. Preliminary studies in mice bearing human head and neck cancers or head and neck cancer cells cultured in laboratories suggest that treatment with 5-azacitidine increases changes in cancer cells that lead to their death. This study is designed to determine if similar changes occur in cancer cells of patients with head and neck cancer.

The study also aims to determine the amount of a specific type of protein, p53 before and after treatment. Research has shown that the p53 protein is associated with anti-tumor activity.

Finally, this study is measuring the amount of a specific type of protein called interferon in your tumor tissue. Interferons are proteins made and released by the body in response to pathogens (disease causing agents) such as viruses, bacteria, or tumor cells. Interferons allow for communication between cells to trigger the protective defenses of the immune system that remove pathogens (disease causing agents) or tumors.
Detailed Description
Primary Objectives:

The primary objectives of this study are

• to investigate response (proliferation, apoptosis), as well as reactivation of p53 pathways in patients treated with 5-azacitadine for HPV-positive and HPV-negative HNSCC.

Secondary Objectives

The secondary objectives of this study are:

- to investigate response (proliferation, apoptosis), as well as reactivation of IFN pathways in patients treated with 5-azacitadine for HPV-positive and HPV-negative HNSCC.

- to investigate the clinical activity of 5-azacitadine in patients with HPV-positive and HPV-negative HNSCC.

- to investigate the safety of 5-azacitadine in patients with HPV-positive and HPV-negative HNSCC
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Histologically confirmed HNSCC with surgically resectable disease

2. Age ≥18 years of age.

3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2

4. ANC greater than or equal to 1500, Hb greater than or equal to 8, platelet count greater than or equal to 100,000

Exclusion Criteria:

1. AST or ALT greater than 2.5 x ULN

2. Known brain metastases

3. Women must not be pregnant or breastfeeding

4. Known allergy to 5-azacitadine

5. Patients receiving any other investigational agents within 4 weeks of starting the study
Location
Smilow Cancer Center at Yale New Haven Hospital
New Haven, Connecticut, United States
Status: Not yet recruiting
Contact: Hari A Deshpande, MD - 203-200-4622 - hari.deshpande@yale.edu
Start Date
July 2014
Completion Date
December 2016
Sponsors
Yale University
Source
Yale University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page