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

NCT00712062 | Withdrawn Phase 2 DMC

• 1 other identifier: PCNSL-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Central Nervous System Lymphoma

Keywords

PCNSL; Pemetrexed; Alimta; Recurrent; Progressive

Outcome Measures

Primary Outcomes (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.

  2.5 Years

Secondary Outcomes (2)

• 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

Study Arms (1)

Pemetrexed

EXPERIMENTAL

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

Drug: Pemetrexed

Interventions

Pemetrexed DRUG

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

Also known as: Alimta

Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

Recurrence

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Erin M Dunbar, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 9, 2008
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: September 20, 2011

Record last verified: 2011-09