Window Trial 5-aza in HNSCC, T-tare

Overseen by Barbara Burtness, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Yale University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Barbara Burtness, MD

Principal Investigator

Yale University School of Medicine, Smilow Cancer Center at Yale New Haven Hospital, Yale Comprehensive Cancer Center

Eligibility Criteria

Inclusion Criteria

Histologically confirmed p16 or HPV PCR positive HNSCC with surgically resectable disease

Age ≥18 years of age.

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

Treatment Details

Interventions

• 5-Azacitadine (Anti-metabolites)

Participant Groups

Group I: HPV positive Experimental Treatment 1 Intervention

HPV positive patients

Group II: HPV negative Experimental Treatment 1 Intervention

HPV negative patients

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University