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

• Status: Withdrawn
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Pemetrexed

Criteria

Inclusion Criteria:

• Histological confirmation of Primary Central Nervous System Lymphoma

• Male or female > 18 years of age or older

• Negative pregnancy test (if of childbearing potential)

• Any number of previous recurrences will be allowed

• Karnofsky Performance Status > 60

• Hematocrit > 30,000

• Platelet > 100,000

• Absolute Neutrophil Count > 1,500

• Bilirubin < 1.5 x upper limits of normal

• Transaminases (ALT and AST) < 1.5 x upper limits of normal

• Creatinine < 1.5 x upper limits of normal

• Creatinine Clearance > 45 mL/min

• Adequate medical health to participate in this study

• Adequate documentation of menopause (natural/surgical) or patient commitment to routine use of reliable birth control (barrier/hormonal)

• Ability to read and understand the patient informed consent form

• Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed, and completion of all diaries and forms

Exclusion Criteria:

• Karnofsky Performance Status < 60

• Hematocrit < 30,000

• Platelet < 100,000

• Absolute Neutrophil Count < 1,500

• Bilirubin >1.5 x upper limits of normal

• Transaminases (ALT & AST) > 1.5 x upper limits of normal

• Creatinine > 1.5 x upper limits of normal

• Creatinine Clearance < 45 mL/min

• Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis