A Phase II Trial of Alimta (Pemetrexed) in Patients With Recurrent Malignant Gliomas, Primary Central Nervous System Lymphoma, and Brain Metastases
- 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.
- 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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival at 6 months and time to disease progression
After every 2 cycles of therapy (1 cycle = 3 weeks) until disease progression
Jeffrey J. Raizer, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Hematology-Oncology Associates of Illinois||Chicago, Illinois 60611-2998|