Nelfinavir in Recurrent Adenoid Cystic Cancer of the Head and Neck

Summary

The purpose of this study is to evaluate the FDA-approved drug nelfinavir (NFV) as an oncologic agent for adenoid cystic cancers of the head and neck. Specifically, subjects will be asked to take 1250 mg twice daily and follow-up with their medical oncologist as clinically indicated while taking this medication. Subjects would be evaluated for quality of life issues utilizing the EORTC QLQ-C30 2-page questionnaire. Subjects would also be evaluated clinically by the oncologist to determine if the NFV was having an anti-neoplastic effect. The study remains unfunded. Therefore, potential subjects must be willing to provide self-travel to study site. This study requires a screening visit, initial study visit, and monthly follow-up. Subjects are not reimbursed for time, travel, or physician costs.

Timeline

Start

2009-10

Primary completion

2015-05

Completion

2017-11

Publications

• Background Gupta AK, Wilke WW, Taylor EN, Bodeker KL, Hoffman HT, Milhem MM, Buatti JM, Robinson RA. Signaling pathways in adenoid cystic cancers: implications for treatment. Cancer Biol Ther. 2009 Oct;8(20):1947-51. doi: 10.4161/cbt.8.20.9596. Epub 2009 Oct 22.
• Results Hoover AC, Milhem MM, Anderson CM, Sun W, Smith BJ, Hoffman HT, Buatti JM. Efficacy of nelfinavir as monotherapy in refractory adenoid cystic carcinoma: Results of a phase II clinical trial. Head Neck. 2015 May;37(5):722-6. doi: 10.1002/hed.23664. Epub 2014 Jun 18.

Drugs

Indications