NCT02178072

Window Trial 5-aza in HNSCC, T-tare

Completed Phase 1 Last updated 15 February 2022

What this trial tests

Phase 1 trial testing 5-Azacitadine in Head and Neck Squamous Cell Carcinoma in 18 participants. Completed in 23 October 2019.

Timeline

19 February 2015

Primary endpoint
23 October 2019

23 October 2019

Quick facts

Lead sponsor	Yale University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	19 February 2015
Primary completion	23 October 2019
Estimated completion	23 October 2019
Sites	1 location across United States

Drugs / interventions tested

• 5-Azacitadine — full drug profile →

Conditions studied

• Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →

Sponsor

Yale University

Who can join

Adults 18 to 99, any sex, with Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting epigenetic regulators for cancer therapy: mechanisms and advances in clinical trials.
   Cheng Y, He C, Wang M, Ma X, et al · · 2019 · cited 760× · PMID 31871779 · DOI 10.1038/s41392-019-0095-0
2. Targeting epigenetic regulators to overcome drug resistance in cancers.
   Wang N, Ma T, Yu B, Yu B. · · 2023 · cited 213× · PMID 36797239 · DOI 10.1038/s41392-023-01341-7
3. Cancer stem cell secretome in the tumor microenvironment: a key point for an effective personalized cancer treatment.
   López de Andrés J, Griñán-Lisón C, Jiménez G, Marchal JA. · · 2020 · cited 145× · PMID 33059744 · DOI 10.1186/s13045-020-00966-3
4. Recent developments in epigenetic cancer therapeutics: clinical advancement and emerging trends.
   Nepali K, Liou JP. · · 2021 · cited 122× · PMID 33840388 · DOI 10.1186/s12929-021-00721-x
5. HPV-driven oropharyngeal cancer: current knowledge of molecular biology and mechanisms of carcinogenesis.
   Pan C, Issaeva N, Yarbrough WG. · · 2018 · cited 79× · PMID 31093365 · DOI 10.1186/s41199-018-0039-3
6. The paradigm of drug resistance in cancer: an epigenetic perspective.
   Adhikari S, Bhattacharya A, Adhikary S, Singh V, et al · · 2022 · cited 52× · PMID 35438143 · DOI 10.1042/bsr20211812
7. Therapeutic strategies of different HPV status in Head and Neck Squamous Cell Carcinoma.
   Sun Y, Wang Z, Qiu S, Wang R. · · 2021 · cited 43× · PMID 33867833 · DOI 10.7150/ijbs.58077
8. Impact of Epigenetic Regulation on Head and Neck Squamous Cell Carcinoma.
   Bais MV. · · 2019 · cited 33× · PMID 30615537 · DOI 10.1177/0022034518816947