A Phase II Trial of the HIV Protease Inhibitor Nelfinavir in Patients With Recurrent Symptomatic Adenoid Cystic Cancers of the Head and Neck
The hypothesis of this study is that nelfinavir, by inhibiting the Akt and MAPK pathways,
can inhibit adenoid cystic carcinoid growth. These cancers are heavily dependent on these
Adenoid cystic carcinomas (ACC) are rare and account for about 1% of all head and neck
cancers. They stem from salivary glands and are known for their tendency to spread along
nerve sheaths (perineural spread). ACC is known for its prolonged clinical course, multiple
recurrence and the delayed onset of distant metastases. The median/mean age at presentation
is 47-56. Although 5 year disease free survivals (DFS) are 65-70%, the 15 year DFS drops to
30-40%. If followed long enough, 35% of patients will eventually develop metastatic disease.
The most common treatment of ACC is surgery followed by post-operative radiotherapy. When
ACC recurs, management options are often limited both by the morbidity and low efficacy of
re-irradiation and repeated surgical resection. Reported response rates to chemotherapy are
low and when it occurs, the duration of the response is short lived.
In an effort to explore possible targeted therapies for patients with recurrent ACC, Dr.
Gupta's lab examined the activation of 3 signaling proteins (EGFR, Akt, and MAPK) in 9
different paraffinized tissue blocks. Initial indications from in vitro studies demonstrates
NFV is tumoricidal at clinically achievable concentrations. To explore the clinical benefit
of this FDA-approved medication, we seek to implement its off label use in patients who have
failed all other therapies and have no other therapeutic options left.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Every 1 to 3 months
John M. Buatti, M.D.
The University of Iowa
United States: Institutional Review Board
|The Holden Comprehensive Cancer Center||Iowa City, Iowa 52242|