Last reviewed · How we verify
A Pilot Study of Raltegravir and Cisplatin in Squamous Cell Carcinoma of the Head and Neck
The proposed study is a first-in-human pilot of a novel anti-cancer strategy: Metnase inhibition to potentiate DNA damaging chemotherapy. The investigators will conduct serial tumor biopsies in subjects with HNSCC at three timepoints: baseline, after cisplatin, and after cisplatin-raltegravir. The investigators will investigate immunohistochemical expression changes of γH2AX, Chk2, and Annexin V, three biomarkers of DNA damage and apoptosis. The study is designed to identify an intermediate signal of the potentiation of cisplatin chemotherapy by raltegravir in HNSCC, which will justify a future phase I/II study.
Details
| Lead sponsor | New Mexico Cancer Research Alliance |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | COMPLETED |
| Enrolment | 5 |
| Start date | 2010-12 |
| Completion | 2015-04 |
Conditions
- Head and Neck Cancer
Interventions
- raltegravir and cisplatin
Primary outcomes
- Gene expression modification — 3 weeks
Expression changes of three selected tumor biomarkers (DNA damage and apoptosis) will be measured at baseline, after cisplatin alone, and after raltegravir-cisplatin. Tumor biomarkers include pChk2, Annexin V, and metnase.
Countries
United States