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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Primary Central Nervous System Lymphoma
• Intervention / Treatment: Drug: Pemetrexed

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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Alimta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	2.5 Years

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate the longitudinal effect of intravenous pemetrexed on traditional quality of life and performance status measurements.	2.5 Years
Evaluate the longitudinal tolerability of intravenous pemetrexed using standardized toxicity criteria.	2.5 Years

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): February 1, 2010
• Study Completion (ACTUAL): February 1, 2010

Study Registration Dates

• First Submitted: July 3, 2008
• First Submitted That Met QC Criteria: July 8, 2008
• First Posted (ESTIMATE): July 9, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 20, 2011
• Last Update Submitted That Met QC Criteria: September 16, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Pemetrexed; Progressive; Recurrent; PCNSL; Alimta
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Pemetrexed
• Other Study ID Numbers: PCNSL-001