Name of the Trial
Phase I/II Study of Bortezomib Alone or With Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (EPOCH) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (NCI-03-C-0096). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-03-C-0096.

Principal Investigator
Dr. Wyndham Wilson, NCI Center for Cancer Research.

Why Is This Trial Important?
B-cell lymphoma is a cancer caused by uncontrolled growth of B cells, white blood cells that produce the body's disease fighting antibodies. This common cancer strikes an estimated 41,000 Americans each year.

Bortezomib, one of a new class of targeted anticancer drugs called proteasome inhibitors, has shown effectiveness against relapsed (worsening after a period of improvement) or refractory (treatment-resistant) blood-cell cancers in other clinical studies. This trial will compare bortezomib alone against bortezomib added to a chemotherapy combination known as EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) to see which is more effective in fighting relapsed or refractory large B-cell lymphoma.

"Because bortezomib targets a pathway important in certain types of diffuse large B-cell lymphoma, we hope that it will make these tumors more sensitive to chemotherapy and, perhaps, even cause tumors to shrink on their own" said Dr. Wilson.

"EPOCH already has been shown to be a very good regimen for people with this disease," Dr. Wilson added. "With this study, the first to combine bortezomib and EPOCH, we hope to see the agents work in synergy to produce even better results."

Who Can Join This Trial?
This trial seeks to enroll 50 patients, aged 18 and older, who have relapsed or treatment-resistant large B-cell lymphoma. See the full list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-03-C-0096.

Where Is This Trial Taking Place?
Study sites in the United States are enrolling patients in the trial. See the list of sites at http://cancer.gov/clinicaltrials/NCI-03-C-0096.

Who To Contact
See the list of study contacts at http://cancer.gov/clinicaltrials/NCI-03-C-0096 or call the NCI's Clinical Studies Support Center (CSSC) at 1-888-NCI-1937. The call is toll free and completely confidential.