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Prepublished online as a Blood First Edition Paper on September 5, 2002; DOI 10.1182/blood-2002-06-1636.
Submitted June 4, 2002
Accepted August 15, 2002
Rituximab therapy for CNS lymphomas: targeting the leptomeningeal compartment
James L Rubenstein*, Dan Combs, Jay Rosenberg, Arthur Levy, Michael McDermott, Lloyd Damon, Robert Ignoffo, Kenneth Aldape, Arthur Shen, Dana Lee, Antonio Grillo-Lopez, and Marc Shuman
Division of Hematology/Oncology, University of California, San Francisco, San Francisco, CA, USA; Comprehensive Cancer Center, University of California, San Francisco, San Francsico, CA, USA
Genentech Inc., South San Francisco, CA, USA
IDEC Pharmaceutical Corp., South San Francisco, CA, USA
Private Practice, New Haven, CT, USA
Comprehensive Cancer Center, University of California, San Francisco, San Francsico, CA, USA; Department of Neurosurgery, University of California, San Francisco, San Francisco, CA, USA
Department of Pathology, University of California, San Francisco, San Francisco, CA, USA
Division of Hematology/Oncology, University of California, San Francisco, San Francisco, CA, USA
Division of Hematology/Oncology, University of California, San Francisco, San Francisco, CA, USA; Comprehensive Cancer Center, University of California, San Francisco, San Francsico, CA, USA; Cancer Research Institute, University of California, San Francisco, San Francisco, CA, USA
* Corresponding author; email: jamesr{at}medicine.ucsf.edu.
The majority of lymphomas that involve the central nervous system are B-cell neoplasms which express the cell surface molecule CD20. After intravenous administration, rituximab can be reproducibly measured in the cerebrospinal fluid (CSF) in patients with primary central nervous system lymphoma, however, the CSF levels of rituximab are approximately 0.1% of serum levels associated with therapeutic activity in patients with systemic non-Hodgkin's lymphoma. Because lymphomatous meningitis is a frequent complication of non-Hodgkin's lymphoma, we have conducted an analysis of the safety and pharmacokinetics of direct intrathecal administration of rituximab using cynomologous monkeys. No significant acute or delayed toxicity, neurologic or otherwise, was detected. Pharmacokinetic analysis suggests that drug clearance from the CSF is biphasic with a terminal half-life of 4.96 hours. A phase I study to investigate the safety and pharmacokinetics of intrathecal rituximab in patients with recurrent lymphomatous meningitis will be implemented based on these findings.
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