Window Trial 5-aza in HNSCC, T-tare
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 7/15/2018 |
| Start Date: | July 2014 |
| End Date: | December 2018 |
| Contact: | Hari A Deshpande, MD |
| Email: | hari.deshpande@yale.edu |
| Phone: | 203-200-4622 |
A Window Study to Assess the Activity of Demethylation Therapy in Patients With HPV-Positive Compared With HPV-Negative Head and Neck Squamous Cell Carcinoma, With Response Assessment and Biomarker Expansion Cohort in HPV-Positive Oropharynx Cancer
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.
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.
Primary Objectives:
The primary objectives of this study are:
• to determine the proportion of HPV-positive patients in whom 5-azacytidine increases APOBEC
RNA expression.
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
The primary objectives of this study are:
• to determine the proportion of HPV-positive patients in whom 5-azacytidine increases APOBEC
RNA expression.
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
Inclusion Criteria:
1. Histologically confirmed p16 or HPV PCR positive 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
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