The Virginia Commonwealth University Massey Cancer Center recently opened a National Cancer Institute (NCI)-sponsored, phase II clinical study for certain sub-types of non-Hodgkin’s lymphoma.
The study is based on research from VCU Massey Cancer Center as well as other centers suggesting that combining two novel, recently approved drugs that have shown effectiveness in certain blood cancers may be active in patients with diffuse large B-cell lymphoma, or mantle cell lymphoma. The study is intended for patients whose disease has progressed following treatment with other regimens.
Other NCI centers participating in this novel lymphoma study through the NCI’s Southeast Phase II Consortium include H. Lee Moffitt Cancer Center and Research Institute (Tampa, Fla.), which is the coordinating center; the University of North Carolina Lineberger Comprehensive Cancer Center (Chapel Hill, N.C.); and the Vanderbilt-Ingram Cancer Center (Nashville, Tenn.). Also planning to participate are Montefiore-Einstein Cancer Center (New York); and New York Presbyterian Hospital / Weill Cornell Medical College, both of which are in the NCI-sponsored New York Phase II Consortium.
The investigators hope to learn whether these types of lymphoma respond to treatment with the combination of bortezomib, marketed as Velcade, and vorinostat, marketed as Zolinza. They also intend to learn about the side effects of this drug regimen and whether certain features of these lymphomas might predict for response to this regimen.
Steven Grant, M.D., principal investigator of the study and associate director for translational research at VCU Massey Cancer Center, is among a number of researchers worldwide who have reported synergistic interactions between proteasome inhibitors such as bortezomib and histone deacetylase inhibitors such as vorinostat in leukemia and other hematologic malignancies. Other cancer centers are currently exploring this drug combination in patients with refractory multiple myeloma.
“Phase I data from studies in patients with multiple myeloma have given us a good idea of safe and appropriate doses of these two agents when they are administered in combination. Such information has allowed us to open this as a Phase II study in patients with lymphoma to determine how effective this novel drug combination is in this setting,” said Grant. “The hematologic cancer research community has considerable interest in combination regimens incorporating these two important classes of new agents.”
Within the mantle cell lymphoma patient group, the study will assess whether patients who have previously received bortezomib respond differently from those who have never been treated with bortezomib. Bortezomib administered alone has recently been approved for the treatment of patients with relapsed or refractory mantle cell lymphoma, and previously was approved for patients with progressive multiple myeloma. Vorinostat has been approved for use in patients with cutaneous T-cell lymphoma.
Diffuse large B-cell lymphoma is a type of non-Hodgkin’s lymphoma — cancer of the immune system — that is usually fast-growing. It is the most common type of non-Hodgkin’s lymphoma, and is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow or other organs. Other symptoms include fever, night sweats and weight loss. There are several subtypes of diffuse large B-cell lymphoma.
Mantle cell lymphoma is a fast-growing type of B-cell non-Hodgkin’s lymphoma that usually occurs in middle-aged or older adults. It is marked by small- to medium-size cancer cells that may be in the lymph nodes, spleen, bone marrow, blood, and gastrointestinal system.
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