Nelfinavir in Recurrent Adenoid Cystic Cancer of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT01065844|
Recruitment Status : Completed
First Posted : February 9, 2010
Results First Posted : December 19, 2016
Last Update Posted : December 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Adenoid Cystic Head and Neck Neoplasms||Drug: Nelfinavir||Phase 2|
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 signalling pathways.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of the HIV Protease Inhibitor Nelfinavir in Patients With Recurrent Symptomatic Adenoid Cystic Cancers of the Head and Neck|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||November 2017|
1250 mg Nelfinavir twice daily Monday-Sunday
1250 mg Nelfinavir twice daily Monday - Sunday
- Tumor Progression [ Time Frame: Every 1 to 3 months ]Tumor progression as defined by RECIST version v1.1 criteria with ordinal measurements of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).
- Quality of Life [ Time Frame: every 1 to 3 months ]Quality of life as measured by the EORTC QLQ-C30 survey
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065844
|United States, Iowa|
|The Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||John M. Buatti, M.D.||The University of Iowa|