NCT01275183

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	raltegravir and cisplatin	Cisplatin, intravenous, 30 mg/m2, days 2 and 16, 1 to 2 hours Raltegravir, oral,400 mg, twice per day, days 1 through 5 or days 15 to 19 Part 2 (optional): Docetaxel, intravenous, 75 mg/M2, day 2, every 21 days, 3 to 6 cycles Part 2 (optional): Cisplatin, intravenous, 75 mg/M2, day 2, every 21 days, 3 to 6 cycles Part 2: (optional): Raltegavir, oral, 400 mg, twice per day, days 1 through 5, 3 to 6 cycles

Timeline

• Start date: 2010-12-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2011-01-12
• Last updated: 2015-06-18

Locations

1 site across 1 country: United States