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Monoclonal Antibody Therapy for Treatment-Resistant Blood Cancers
Untitled Document
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
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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.
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