Name of the Trial
Phase I Study of Bortezomib and Radiotherapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (NCI-01-C-0104). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-01-C-0104.

Investigators
Dr. Barbara A. Conley, principal investigator, NCI's Center for Cancer Research; Dr. Carter Van Waes, co-investigator, National Institute on Deafness and Other Communication Disorders; and Dr. David Gius, co-investigator, NCI's Radiation Oncology Branch

Why Is This Trial Important?
Head and neck cancers account for three percent of all cancers in the United States. Most of these cancers begin in squamous cells found in the lining of structures in the head and neck. Initial treatment options for most patients with head and neck cancer include surgery followed by radiation therapy or chemotherapy combined with radiation treatment. No standard therapy currently exists for head or neck cancer that recurs after treatment with radiation.

In the past, doctors have been reluctant to re-treat patients with radiation if their cancer recurred. However, some studies of "re-irradiation" have shown long-term survival rates of up to 20 percent. This study is the first test of whether the drug bortezomib (Velcade™) can increase the effectiveness of re-irradiation. Bortezomib, a proteasome inhibitor, is one of the new class of targeted cancer therapies. Proteasomes are clusters of proteins necessary for cancer cell growth.

"In preclinical studies conducted in the laboratories of Drs. Carter Van Waes and James Mitchell at NIH, bortezomib has been shown to inhibit growth of head and neck cancer cells, inhibit their blood supply, and enhance the effect of radiation," said Dr. Conley. "In this study we hope to see a similar effect in patients."

Another goal of this phase I study is to identify the most tolerable dose of bortezomib that can be given with radiation to the head and neck.

Who Can Join This Trial? This trial seeks to enroll 51 patients aged 19 and older with squamous cell carcinoma of the head and neck that has recurred after initial treatment or metastasized to areas other than the brain. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/NCI-01-C-0104.

Where Is This Trial Taking Place? This study is taking place at the National Institutes of Health Warren G. Magnuson Clinical Center in Bethesda, Md.

Who to Contact For more information, call the study nurse, Christine Muir, at 301-594-6590, or call the NCI Clinical Studies Support Center (CSSC) at 1-888-NCI-1937. The CSSC provides information about cancer trials taking place on the NIH campus in Bethesda, Md. The call is toll free and confidential.