Sylvester Comprehensive Cancer Center

UM/Sylvester Opens New Clinical Trial of Novel Combination Therapy in Lymphoma and Leukemia

06.30.2004

The University of Miami Sylvester Comprehensive Cancer Center has opened a phase I clinical trial of a novel combination therapy for patients with certain types of leukemia and lymphoma. “The idea of this trial is to use an antibody which has had some success in the treatment of these disorders, but to try and augment the effects of that antibody in combination with Interleukin-2,” said Joseph D. Rosenblatt, M.D., associate director, clinical and translational research, UM/Sylvester.

Campath-1H, also called Alemtuzumab, is an approved form of treatment for patients with refractory/relapsed B-cell chronic lymphocytic leukemia, T prolymphocytic leukemia, and cutaneous T cell lymphomas (Sezary syndrome). However many patients have only partial or short-lived responses. In other patients Alemtuzumab depletes normal lymphocytes called T cells that are needed to fight infection. That could raise their susceptibility to opportunistic infections for months after treatment.

Interleukin-2 is a naturally occurring protein that spurs growth in two types of immune system lymphoid cells: T cells and natural killer cells. Natural killer cells appear to interact with Alemtuzumab-targeted lymphoma or leukemia cells and can kill them through a mechanism known as antibody-mediated cytotoxicity. Alemtuzumab may work by directly destroying leukemia and lymphoma cells, and by targeting them for destruction by natural killer cells. Therefore, Interleukin-2 may help in two ways – by creating more natural killer cells to attach to the antibody, and by facilitating the recovery of T cells in the immune system following Alemtuzumab treatment.

“We believe that by using IL-2 and Alemtuzumab in combination we may be able to hasten the return of the immune system to normal by enhancing the recovery of T cells and reducing post-treatment infectious complications,” said Rosenblatt. “We also hope to increase the number and potency of natural killer cells, thereby potentiating the anti-tumor effects of Alemtuzumab.”

This year in the United States about 12,000 people will be diagnosed with these two types of leukemia, and another 2,500 will be diagnosed with cutaneous T cell lymphoma, which is also known as Sezary syndrome. More than 6,000 Americans are expected to die of these illnesses this year.

“We plan to study both reconstitution of the immune system as well as response of the tumor,” said Rosenblatt. The idea of combining these two drugs was developed at UM/Sylvester by Dr. Rosenblatt, Edgardo Santos, M.D., and their colleagues in Hematology Oncology at the University of Miami School of Medicine. The study is being supported by both Chiron and Berlex, manufacturers of IL-2 and Alemtuzumab respectively. Patients seeking additional information regarding this clinical trial should call (305) 243-1000.

UM/Sylvester was founded in 1992 to provide comprehensive cancer services and today serves as the hub for cancer-related research, diagnosis, and treatment at the University of Miami School of Medicine. UM/Sylvester handles more than 1,100 inpatient admissions annually, performs 2,800 surgical procedures, and treats 2,900 new cancer patients. All UM/Sylvester physicians are on the faculty of the University of Miami School of Medicine, South Florida’s only academic medical center. In addition, UM/Sylvester physicians and scientists are engaged in more than 150 clinical trials and receive more than $30 million annually in research grants. UM/Sylvester at Deerfield Beach recently opened to better meet the needs of residents of Broward and Palm Beach Counties. This 10,000 square-foot facility at I-95 and S.W. 10th Street offers appointments with physicians from six cancer specialties, complementary therapies from the Courtelis Center, and education and outreach events.

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