A Phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of topically-applied AG013 for the attenuation of oral mucositis in subjects with cancers of the head and neck receiving concomitant chemoradiation therapy.

Purpose

To determine the effectiveness as well as safety & tolerability of AG013 in altering the onset, course & severity of oral mucositis compared to placebo (a mouth rinse which looks exactly the same as AG013 but which dose not contain AG013) when administered 3 times each day.

Criteria

Males or females 21 years of age or older diagnosed with squamous call carcinoma of the oral cavity, oropharynx, nasopharynx or hypopharynx or unknown primary HPV-positive tumor presumed to be of the oropharyngeal, nasopharyngeal or hypopharyngeal origin                        

Planned to receive radiation therapy 50-72 Gy           

Planned to receive cisplatin chemotherapy

You Cannot:            

Have had prior radiation to the head and neck

Have had prior gene therapy

Have current use of antibiotic rinses

Details

The total duration for this study is up to 16 months. The study has 4 phases: ·        

Screening Phase- maximum of 4 weeks       

Active Study Treatment Phase- between 7-9 weeks

Short Term Follow-up- 4 weeks      

Long Term Follow-up- 3, 6, & 12 months



Interested in more information on this clinical research study?

Contact WK Cancer Center Clinical Research Department at 318-212-8671

Interested in more information? Contact Us:

Radiation Oncology Services

IRB: Advarra Institutional Review Board
IRB Number:
Trial Type: NA
Sponsor: Oragenics