Rapamycin Therapy in Head and Neck Squamous Cell Carcinoma
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
Background:
- 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.
Objectives:
- To evaluate the usefulness of rapamycin in decreasing tumor size prior to surgery for head
and neck squamous cell carcinoma.
Eligibility:
- 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.
Design:
- 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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)