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Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma

This study has been withdrawn prior to enrollment.
(Lack of accrual)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00712062
First received: July 3, 2008
Last updated: September 16, 2011
Last verified: September 2011
History of Changes
  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
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
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

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
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
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013