Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma
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ClinicalTrials.gov Identifier: NCT00712062 |
Recruitment Status :
Withdrawn
(Lack of accrual)
First Posted : July 9, 2008
Last Update Posted : September 20, 2011
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Condition or disease | Intervention/treatment | Phase |
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Primary Central Nervous System Lymphoma | Drug: Pemetrexed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Pemetrexed
500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity.
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Drug: Pemetrexed
500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity.
Other Name: Alimta |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712062
Principal Investigator: | Erin M Dunbar, MD | University of Florida |
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00712062 |
Other Study ID Numbers: |
PCNSL-001 |
First Posted: | July 9, 2008 Key Record Dates |
Last Update Posted: | September 20, 2011 |
Last Verified: | September 2011 |
PCNSL Pemetrexed Alimta Recurrent Progressive |
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
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