Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma - Full Text View

Purpose

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 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Pemetrexed Pemetrexed disodium

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Primary Central Nervous System Lymphoma

U.S. FDA Resources

Further study details as provided by University of Florida:

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. [ Time Frame: 2.5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the longitudinal effect of intravenous pemetrexed on traditional quality of life and performance status measurements. [ Time Frame: 2.5 Years ] [ Designated as safety issue: No ]
Evaluate the longitudinal tolerability of intravenous pemetrexed using standardized toxicity criteria. [ Time Frame: 2.5 Years ] [ Designated as safety issue: Yes ]


Enrollment:	0
Study Start Date:	February 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pemetrexed 500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity.	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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712062

Sponsors and Collaborators

University of Florida

Investigators


Principal Investigator:	Erin M Dunbar, MD	University of Florida

More Information


Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT00712062 History of Changes
Other Study ID Numbers:	PCNSL-001
Study First Received:	July 3, 2008
Last Updated:	September 16, 2011
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by University of Florida:


PCNSL Pemetrexed Alimta Recurrent Progressive

Additional relevant MeSH terms:


Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases	Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016