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Sponsored by: |
University of Florida |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00712062 |
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.
Condition | Intervention | Phase |
---|---|---|
Primary Central Nervous System Lymphoma |
Drug: Pemetrexed |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christine Keeling, BSN, OCN | 352-273-7981 | christine.keeling@neurosurgery.ufl.edu |
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32610 | |
Contact: Christine Keeling, BSN, OCN 352-273-7981 christine.keeling@neurosurgery.ufl.edu | |
Principal Investigator: Erin M Dunbar, MD |
Principal Investigator: | Erin M Dunbar, MD | University of Florida |
Responsible Party: | University of Florida ( Erin M. Dunbar, MD ) |
Study ID Numbers: | PCNSL-001 |
Study First Received: | July 3, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00712062 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
PCNSL Pemetrexed Alimta Recurrent Progressive |
Folic Acid Pemetrexed Lymphatic Diseases Immunoproliferative Disorders |
Lymphoproliferative Disorders Lymphoma Recurrence Central nervous system lymphoma, primary |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions |