Pilot Study to Determine Therapeutic Response of Pemetrexed (Alimta) in Recurrent or Progressive Primary Central Nervous System Lymphoma (PCNSL) by Establishing the Radiographic Response Rate Using Modified Macdonald Criteria
Despite the aggressive upfront use of methotrexate-based chemotherapy, primary central
nervous system lymphoma (PCNSL) almost uniformly results in recurrence or progression and
death. Palliative chemotherapy offers an improvement in time-to-progression, symptom
control, quality of life, and potentially, survival. However, no established chemotherapy
regimen for recurrence exists and new treatments are needed. Pemetrexed is a rationale
strategy for therapeutic palliation of recurrent or progressive PCNSL, given its mechanism
of action, convenient administration, single agent efficacy, its well established management
algorithms, and its evidence of safety and efficacy in systemic malignancies.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the therapeutic response of intravenous pemetrexed in recurrent or progressive primary central nervous system lymphoma by establishing the radiographic response rate using modified Macdonald criteria.
Erin M Dunbar, MD
University of Florida
United States: Institutional Review Board