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

Sponsor:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00712062

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 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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Pemetrexed Pemetrexed disodium

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 ]

Estimated Enrollment:	30
Study Start Date:	February 2009
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

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
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

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

Contacts

Contact: Christine Keeling, BSN, OCN

352-273-7981

christine.keeling@neurosurgery.ufl.edu

Locations

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

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Erin M Dunbar, MD

University of Florida

More Information

No publications provided

Responsible Party:	University of Florida ( Erin M. Dunbar, MD )
Study ID Numbers:	PCNSL-001
Study First Received:	July 3, 2008
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00712062 History of Changes
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:

Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors

Folic Acid Antagonists
Pharmacologic Actions
Pemetrexed
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 20, 2009