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

• ClinicalTrials.gov Identifier: NCT00712062
• Recruitment Status: Withdrawn
• First Posted: July 9, 2008
• Last Update Posted: September 20, 2011
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Primary Central Nervous System Lymphoma	Drug: Pemetrexed	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: February 2009
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: February 2010

Arms and Interventions

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 Name: Alimta

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Evaluate the longitudinal effect of intravenous pemetrexed on traditional quality of life and performance status measurements. [ Time Frame: 2.5 Years ]
2. Evaluate the longitudinal tolerability of intravenous pemetrexed using standardized toxicity criteria. [ Time Frame: 2.5 Years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: PCNSL-001
• First Posted: July 9, 2008
• Last Update Posted: September 20, 2011
• Last Verified: September 2011

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