Clinical Trial: Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Pilot Study to Determine Therapeutic Response of Pemetrexed (Alimta) in Recurrent or Progressive Primary Central Nervous System Lymphoma (PCNSL) by Establishing the Radiog

Brief Summary: The purpose of this study is to determine if pemetrexed is effective in the treatment of primary central nervous system lymphoma (PCNSL) that has either worsened during treatment or has returned after completing treatment.

Detailed Summary: 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.
Sponsor: University of Florida

Current Primary Outcome: 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. [ Time Frame: 2.5 Years ]

Original Primary Outcome: Determine the therapeutic response of intravenous pemetrexed (Alimta) in recurrent or progressive primary central nervous system lymphoma by establishing the radiographic response rate using modified Macdonald criteria. [ Time Frame: 2 Years ]

Current Secondary Outcome:

  • Evaluate the longitudinal effect of intravenous pemetrexed on traditional quality of life and performance status measurements. [ Time Frame: 2.5 Years ]
  • Evaluate the longitudinal tolerability of intravenous pemetrexed using standardized toxicity criteria. [ Time Frame: 2.5 Years ]


Original Secondary Outcome:

  • Evaluate the longitudinal effect of intravenous pemetrexed (Alimta) on traditional quality of life and performance status measurements. [ Time Frame: 2 Years ]
  • Evaluate the longitudinal tolerability of intravenous pemetrexed (Alimta) using standardized toxicity criteria. [ Time Frame: 2 Years ]


Information By: University of Florida

Dates:
Date Received: July 3, 2008
Date Started: February 2009
Date Completion:
Last Updated: September 16, 2011
Last Verified: September 2011