Multicenter Phase II Study of Rituximab and Temozolomide in Recurrent Primary Central Nervous System Lymphoma

Leuk Lymphoma. 2013 Jan;54(1):58-61. doi: 10.3109/10428194.2012.698736. Epub 2012 Jul 9.

Abstract

We initiated a prospective multicenter phase II trial using rituximab and temozolomide in immunocompetent patients with progressive or recurrent primary central nervous system lymphoma (PCNSL) based on activity observed in retrospective studies. Treatment consisted of an induction phase with rituximab (750 mg/m(2)) on days 1, 8, 15 and 22 and temozolomide (150 mg/m(2)) days 1-7 and 15-21, followed by six cycles of consolidation temozolomide (150-200 mg/m(2) × 5/28 days), followed by maintenance with methylprednisolone (1 g IV every 28 days) until progression. Sixteen patients were enrolled, and a complete response was seen in 2/14 (14%) evaluable patients. The median progression-free survival was 7 weeks and median overall survival was not reached (median follow-up: 37 months). Treatment was well tolerated, but due to slow accrual and preliminary analysis suggesting futility, the trial was closed early. Given the overall modest activity, this regimen should be reserved for patients who are not candidates for other, more aggressive salvage treatments.

Trial registration: ClinicalTrials.gov NCT00248534.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal, Murine-Derived / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Brain / pathology
  • Central Nervous System Neoplasms / diagnosis
  • Central Nervous System Neoplasms / drug therapy*
  • Central Nervous System Neoplasms / mortality
  • Dacarbazine / administration & dosage
  • Dacarbazine / analogs & derivatives
  • Female
  • Humans
  • Lymphoma / drug therapy*
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Recurrence
  • Rituximab
  • Salvage Therapy
  • Temozolomide
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Murine-Derived
  • Rituximab
  • Dacarbazine
  • Temozolomide

Associated data

  • ClinicalTrials.gov/NCT00248534