Monoclonal Antibody Therapy for Treatment-Resistant Blood Cancers

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.

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 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.