Status:
WITHDRAWN
Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma
Lead Sponsor:
University of Florida
Conditions:
Primary Central Nervous System Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
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 chemo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00712062
Start Date
February 1 2009
End Date
February 1 2010
Last Update
September 20 2011
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