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

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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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

Conditions
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Primary Central Nervous System Lymphoma

Intervention / Treatment
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* Drug: Pemetrexed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pemetrexed<br>500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity. | Drug: Pemetrexed<br>* 500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity.<br>* Other names: Alimta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 2.5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the longitudinal effect of intravenous pemetrexed on traditional quality of life and performance status measurements. |  | 2.5 Years | 
| Evaluate the longitudinal tolerability of intravenous pemetrexed using standardized toxicity criteria. |  | 2.5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCNSL, Pemetrexed, Alimta, Recurrent, Progressive