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A Phase I Study of Post-Operative Radiation Therapy plus RAD001 (Everolimus) and Cisplatin for Patients with Head and Neck Cancer
[Protocol 08-138]
- Full Title :
- A PHASE I STUDY OF RADIATION THERAPY (IMRT) + RAD001(EVEROLIMUS) + CISPLATIN FOR PATIENTS WITH HEAD AND NECK CANCER
- Purpose :
Radiation therapy given concurrently with high doses of cisplatin is a standard treatment for head and neck cancers that have been surgically removed, to reduce the risk of cancer recurrence. However, high doses of cisplatin can cause severe side effects for some patients. In this study, researchers are evaluating the effectiveness of the combination of radiation therapy, low-dose cisplatin, and an investigational drug called RAD001 (everolimus) in patients with head and neck cancer that has been surgically removed.
RAD001 is a pill designed to stop cancer cells from growing by inhibiting a protein called mTOR. mTOR helps to control the production of other proteins needed for cancer cell growth. Laboratory studies have shown that adding RAD001 to cisplatin or radiation therapy was more effective than either therapy alone for killing cancer cells.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of head and neck cancer that has been surgically removed.
- Patients may not have had prior chemotherapy, radiation therapy, or treatment with mTOR inhibitors.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Matthew G. Fury at 212-639-3049.
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