drugset / Trial / NCT01275183

Pilot Study of Raltegravir and Cisplatin in Squamous Cell Carcinoma of Head and Neck

NCT01275183

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-12
Primary completion
2015-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 30 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Raltegravir Other / unclassified 400 mg Oral

Indications