RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent malignant gliomas, primary CNS lymphoma, or brain metastases.
OBJECTIVES: Primary * Determine the 6-month progression-free survival rate in patients with recurrent malignant gliomas treated with pemetrexed disodium. * Determine the time to progression in patients with recurrent malignant gliomas, primary CNS lymphoma (PCNSL), or brain metastases treated with pemetrexed disodium. Secondary * Determine the radiographic response in patients with recurrent malignant gliomas, PCNSL, or brain metastases treated with pemetrexed disodium. * Determine the time to response in patients treated with this drug. * Determine the duration of response in patients treated with this drug. * Determine the overall survival of patients treated with this drug. * Collect safety data on patients with intracranial tumors treated with this drug. OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.
Hematology-Oncology Associates of Illinois
Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Progression free survival at 6 months and time to disease progression
Time frame: After every 2 cycles of therapy (1 cycle = 3 weeks) until disease progression
Radiographic response
Time frame: After 6 months of treatment
Collect safety data
Time frame: After every cycle of therapy (cycle = 3 weeks) until disease progression or death.
Overall survival
Time frame: After every cycle of treatment (1 cycle = 3 weeks) until death
Compare blood and tissue methylation patterns and correlate with response.
This was optional for patients.
Time frame: Blood and tissue from baseline, then additional blood every 6 weeks while on treatment
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