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

University of Florida

Status and phase

Withdrawn

Phase 2

Conditions

Primary Central Nervous System Lymphoma

Treatments

Drug: Pemetrexed

Study type

Interventional

Funder types

Other

Identifiers

NCT00712062

PCNSL-001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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