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Window Trial 5-aza in HNSCC, T-tare

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ClinicalTrials.gov Identifier: NCT02178072
Recruitment Status : Recruiting
First Posted : June 30, 2014
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief 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.


Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: 5-Azacitadine Phase 2

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
HPV positive
HPV positive patients
Drug: 5-Azacitadine
Other Name: Vidaza

HPV negative
HPV negative patients
Drug: 5-Azacitadine
Other Name: Vidaza




Primary Outcome Measures :
  1. tumor response [ Time Frame: 6 months ]
    The post-treatment biopsy will occur the day after the last injection of 5-azacytidine. 5-aza is currently FDA-approved and used for therapy of myelodysplastic syndrome. Pre- and post- 5-aza treatment tissue will be analyzed for proliferation (IHC-Ki-67), apoptosis (IHC-cleaved caspase-3, cleaved PARP-1), and for p53 protein (IHC, immunoblots), as well as p53, CDKN1A, MDM2, IFITs, and CCL5 mRNA levels (as described above). The primary outcome is the change from baseline of the p53 protein level in post-treatment vs. pre-treatment biopsies. Although tumor response may not be expected due to the short treatment course, the post-treatment vs. pre-treatment change from baseline of the gross tumor measurements will be used to measure tumor response.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178072


Contacts
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Contact: Hari A Deshpande, MD 203-200-4622 hari.deshpande@yale.edu
Contact: Barbara Burtness, MD 203-737-7636 barbara.burtness@yale.edu

Locations
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United States, Connecticut
Smilow Cancer Center at Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Hari A Deshpande, MD    203-200-4622    hari.deshpande@yale.edu   
Contact: Wendell Yarbrough, MD    203-200-4622    wendell.yarbrough@yale.edu   
Sub-Investigator: Hari A Deshpande, MD         
Principal Investigator: Wendell Yarbrough, MD         
Sub-Investigator: Anne Chiang, MD         
Sub-Investigator: Clarence Sasaki, MD         
Sub-Investigator: Zain Husain, MD         
Principal Investigator: Barbara Burtness, MD         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Barbara Burtness, MD Yale University School of Medicine, Smilow Cancer Center at Yale New Haven Hospital, Yale Comprehensive Cancer Center

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02178072     History of Changes
Other Study ID Numbers: 1404013771
First Posted: June 30, 2014    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Keywords provided by Yale University:
HNSCC

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site