Treatment of Recurrent Primary or Secondary Central Nervous System (CNS) Lymphoma With ALIMTA (Pemetrexed)
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ClinicalTrials.gov Identifier: NCT00916630 |
Recruitment Status :
Completed
First Posted : June 9, 2009
Last Update Posted : September 23, 2015
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Sponsor:
Massachusetts General Hospital
Collaborators:
Beth Israel Deaconess Medical Center
Eli Lilly and Company
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Jorg Dietrich, M.D., Ph.D., Massachusetts General Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | June 5, 2009 | |||
First Posted Date ICMJE | June 9, 2009 | |||
Last Update Posted Date | September 23, 2015 | |||
Study Start Date ICMJE | January 2009 | |||
Actual Primary Completion Date | September 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
To assess the safety and to determine the maximum tolerated dose of pemetrexed given intravenously for the treatment of recurrent lymphoma invading the CNS. [ Time Frame: 6 years ] | |||
Original Primary Outcome Measures ICMJE |
To assess the safety and to determine the maximum tolerated dose of pemetrexed given intravenously for the treatment of recurrent lymphoma invading the CNS. [ Time Frame: 2 years ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Treatment of Recurrent Primary or Secondary Central Nervous System (CNS) Lymphoma With ALIMTA (Pemetrexed) | |||
Official Title ICMJE | A Phase I Study of the Treatment of Recurrent Primary or Secondary CNS Lymphoma With ALIMTA (Pemetrexed), a Novel Anti-Folate | |||
Brief Summary | The purpose of this research study is to determine the safety of the study drug pemetrexed, and the highest dose of this drug that can be given to people safely. Another goal of this research study is to gain information about how the body handles pemetrexed and how pemetrexed may work to treat the participant's lymphoma in the nervous system. Pemetrexed (also known as Alimta) has been approved by the FDA for the treatment of some lung cancers and has been shown to be effective in laboratory studies. Information from these studies suggests that pemetrexed may help to treat patients with either primary or secondary central nervous system lymphoma. | |||
Detailed Description |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Central Nervous System Lymphoma | |||
Intervention ICMJE | Drug: pemetrexed
Given intravenously over a 10 to 20 minute period once every 14 days.
Other Name: Almita
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Study Arms ICMJE | Single-arm treatment
Dose finding study
Intervention: Drug: pemetrexed
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
18 | |||
Original Estimated Enrollment ICMJE |
49 | |||
Actual Study Completion Date ICMJE | September 2015 | |||
Actual Primary Completion Date | September 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00916630 | |||
Other Study ID Numbers ICMJE | 06-097 H3-US-X059 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Jorg Dietrich, M.D., Ph.D., Massachusetts General Hospital | |||
Study Sponsor ICMJE | Massachusetts General Hospital | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | |||
Verification Date | September 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |