Clinical trial NCT00712062: Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Primary Central Nervous System Lymphoma
Keywords: PCNSL
Pemetrexed
Alimta
Recurrent
Progressive
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 2.5 Years
Secondary outcomes:
measure: Evaluate the longitudinal effect of intravenous pemetrexed on traditional quality of life and performance status measurements.
timeFrame: 2.5 Years
measure: Evaluate the longitudinal tolerability of intravenous pemetrexed using standardized toxicity criteria.
timeFrame: 2.5 Years
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Erin M Dunbar, MD
role: PRINCIPAL_INVESTIGATOR
References: