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

NCT ID: NCT00712062

Last Updated: 2011-09-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-02-28

Brief Summary

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.

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.

Conditions

Primary Central Nervous System Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pemetrexed

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

Group Type: EXPERIMENTAL

Pemetrexed

Intervention Type: DRUG

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

Interventions

Pemetrexed

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

Intervention Type: DRUG

Other Intervention Names

Alimta

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin M Dunbar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

PCNSL-001

Identifier Type: -

Identifier Source: org_study_id