Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma
Primary Purpose
Primary Central Nervous System Lymphoma
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Primary Central Nervous System Lymphoma focused on measuring PCNSL, Pemetrexed, Alimta, Recurrent, Progressive
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pemetrexed
Arm Description
500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Evaluate the longitudinal effect of intravenous pemetrexed on traditional quality of life and performance status measurements.
Evaluate the longitudinal tolerability of intravenous pemetrexed using standardized toxicity criteria.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00712062
Brief Title
Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma
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 Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of accrual
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 completing treatment.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Central Nervous System Lymphoma
Keywords
PCNSL, Pemetrexed, Alimta, Recurrent, Progressive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pemetrexed
Arm Type
Experimental
Arm Description
500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Evaluate the longitudinal effect of intravenous pemetrexed on traditional quality of life and performance status measurements.
Time Frame
2.5 Years
Title
Evaluate the longitudinal tolerability of intravenous pemetrexed using standardized toxicity criteria.
Time Frame
2.5 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin M Dunbar, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma
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