Rapamycin Therapy in Head and Neck Squamous Cell Carcinoma
- Advanced-stage head and neck cancer (head and neck squamous cell carcinoma [HNSCC]) has moderately successful treatment outcomes, usually involving surgery as part of the standard treatment. Researchers are investigating the use of the drug rapamycin to prevent tumor growth in HNSCC, and are interested in using it to treat individuals with HNSCC that has not been treated previously with other drugs, radiation, or surgery.
- To evaluate the usefulness of rapamycin in decreasing tumor size prior to surgery for head and neck squamous cell carcinoma.
- Individuals at least 18 years of age who have been diagnosed with advanced head and neck squamous cell carcinoma that has not yet been treated.
- Participants will be screened with a physical examination, medical history, blood tests, and imaging studies.
- Approximately 1 month before scheduled surgery, participants will begin to receive rapamycin. Participants will take rapamycin once daily for 21 days, followed by a 7-day period without the drug.
- During the 21-day rapamycin treatment, participants will have weekly study visits to provide blood and urine samples and have possible tumor biopsies and imaging studies such as x-rays or tumor photographs. Participants will have additional study visits for tests 1 day and 1 week after the end of rapamycin treatment, followed by HNSCC surgery.
- Participants will have a final visit to provide blood samples 30 days after surgery.
- Participants medical records will be reviewed 1 year after surgery; however, participants will not need to have further study visits at this time.
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Procedure: Dynamic CT Perfusion
Procedure: Positron Emission Tomography
Procedure: Measurement Serum Cytokines
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Trial Targeting mTOR as a Novel Mechanism-Based Neoadjuvant Therapy for Head and Neck Cancer|
- Evaluate the antitumoral activity of rapamycin in HNSCC patients in terms of objective responses; investigate underlying molecular changes to identify biomarkers for understanding, monitoring, and predicting a clinical response to rapamycin in H...
- Safety evaluation of rapamycin therapy prior to surgery; dynamic CT perfusion, and FDG-PET; evaluation of tumor proliferation, apoptosis, microvessel density and the underlying molecular changes
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195922
|Contact: Patrice R Williams Yohannes, R.N.||(301) firstname.lastname@example.org|
|Contact: J. Silvio Gutkind, Ph.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||J. Silvio Gutkind, Ph.D.||National Institute of Dental and Craniofacial Research (NIDCR)|