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
18 Years
N/A
Both
Primary Central Nervous System Lymphoma
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
2.5 Years
Safety Issue:
No
Principal Investigator
Erin M Dunbar, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Florida
Authority:
United States: Institutional Review Board
Study ID:
PCNSL-001
NCT ID:
NCT00712062
Start Date:
February 2009
Completion Date:
February 2010
Related Keywords:
- Primary Central Nervous System Lymphoma
- PCNSL
- Pemetrexed
- Alimta
- Recurrent
- Progressive
- Lymphoma
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