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

Primary Central Nervous System Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00712062
• Other study ID #: PCNSL-001
• Status: Withdrawn
• Phase: Phase 2
• First received: July 3, 2008
• Last updated: September 16, 2011
• Start date: February 2009
• Est. completion date: February 2010

Study information

• Verified date: September 2011
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Primary Central Nervous System Lymphoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluate the longitudinal effect of intravenous pemetrexed on traditional quality of life and performance status measurements.		2.5 Years	No
Secondary	Evaluate the longitudinal tolerability of intravenous pemetrexed using standardized toxicity criteria.		2.5 Years	Yes