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Name of the Trial

Phase I Study of Siplizumab (MEDI-507) in Patients With CD2-Positive Lymphoproliferative Disorders (NCI-04-C-0031). See the protocol summary ⁴.

Principal Investigator

Dr. John Edward Janik, NCI Center for Cancer Research.

Why This Trial Is Important

Dr. John E. Janik Principal Investigator

Lymphoproliferative disorders, such as leukemias and lymphomas, are diseases in which cells of the lymphatic system (lymphocytes) grow excessively. These cancers can be especially hard to treat effectively if they arise from a malfunction of in one type of lymphocyte called a T cell.

Siplizumab is a monoclonal antibody that binds to a protein called CD2, which is found abundantly on certain types of lymphocytes including T cells and Natural Killer (NK) cells. Initially developed to treat psoriasis, siplizumab has been shown in clinical studies to trigger T-cell death. This phase I dose-escalation study is investigating safety and tolerability, and will determine the maximum dose of siplizumab that can be given to patients with CD2-positive lymphoproliferative disease.

"Preclinical studies of siplizumab at the NCI produced very promising results, with a short course of treatment yielding a 50 percent cure rate in mice with T-cell non-Hodgkin's lymphoma (NHL)," said Dr. Janik. "Longer courses of treatment led to the treated mice living out their natural life spans.

"Early results from this trial have produced promising responses in some patients, and we hope to follow this research with additional studies combining siplizumab and chemotherapy," Dr. Janik added.

Contact Information

This trial is no longer accepting new patients. To locate other clinical trials for lymphoproliferative disorders, search the NCI's database of clinical trials ¹ or call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The call is toll free and completely confidential.

Published Results

Janik JE, Morris JC, Stetler-Stevenson M, et al.: Phase I trial of siplizumab in CD2-positive lymphoproliferative disease. [Abstract] J Clin Oncol 23 (Suppl 16): A-2533, 174s, 2005.

Glossary Terms

Cancer that starts in blood-forming tissue such as the bone marrow and causes large numbers of blood cells to be produced and enter the bloodstream.

A type of immune cell that is made in the bone marrow and is found in the blood and in lymph tissue. The two main types of lymphocytes are B lymphocytes and T lymphocytes. B lymphocytes make antibodies, and T lymphocytes help kill tumor cells and help control immune responses. A lymphocyte is a type of white blood cell.

Cancer that begins in cells of the immune system. There are two basic categories of lymphomas. One kind is Hodgkin lymphoma, which is marked by the presence of a type of cell called the Reed-Sternberg cell. The other category is non-Hodgkin lymphomas, which includes a large, diverse group of cancers of immune system cells. Non-Hodgkin lymphomas can be further divided into cancers that have an indolent (slow-growing) course and those that have an aggressive (fast-growing) course. These subtypes behave and respond to treatment differently. Both Hodgkin and non-Hodgkin lymphomas can occur in children and adults, and prognosis and treatment depend on the stage and the type of cancer.

A type of protein made in the laboratory that can locate and bind to substances in the body, including tumor cells. There are many kinds of monoclonal antibodies. Each monoclonal antibody is made to find one substance. Monoclonal antibodies are being used to treat some types of cancer and are being studied in the treatment of other types. They can be used alone or to carry drugs, toxins, or radioactive materials directly to a tumor.

The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection) and the best dose. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Because little is known about the possible risks and benefits of the treatments being tested, phase I trials usually include only a small number of patients who have not been helped by other treatments.