Phase I study of intraventricular administration of rituximab in patients with recurrent CNS and intraocular lymphoma.

Journal Article (Journal Article)

PURPOSE: We previously determined that intravenous administration of rituximab results in limited penetration of this agent into the leptomeningeal space. Systemic rituximab does not reduce the risk of CNS relapse or dissemination in patients with large cell lymphoma. We therefore conducted a phase I dose-escalation study of intrathecal rituximab monotherapy in patients with recurrent CNS non-Hodgkin's lymphoma (NHL). PATIENTS AND METHODS: The protocol planned nine injections of rituximab (10 mg, 25 mg, or 50 mg dose levels) through an Ommaya reservoir over 5 weeks. The safety profile of intraventricular rituximab was defined in 10 patients. RESULTS: The maximum tolerated dose was determined to be 25 mg and rapid craniospinal axis distribution was demonstrated. Cytologic responses were detected in six patients; four patients exhibited complete response. Two patients experienced improvement in intraocular NHL and one exhibited resolution of parenchymal NHL. High RNA levels of Pim-2 and FoxP1 in meningeal lymphoma cells were associated with disease refractory to rituximab monotherapy. CONCLUSION: These results suggest that intrathecal rituximab (10 to 25 mg) is feasible and effective in NHL involving the CNS.

Full Text

Duke Authors

Cited Authors

  • Rubenstein, JL; Fridlyand, J; Abrey, L; Shen, A; Karch, J; Wang, E; Issa, S; Damon, L; Prados, M; McDermott, M; O'Brien, J; Haqq, C; Shuman, M

Published Date

  • April 10, 2007

Published In

Volume / Issue

  • 25 / 11

Start / End Page

  • 1350 - 1356

PubMed ID

  • 17312328

Electronic International Standard Serial Number (EISSN)

  • 1527-7755

Digital Object Identifier (DOI)

  • 10.1200/JCO.2006.09.7311


  • eng

Conference Location

  • United States