Pemetrexed Disodium in Treating Patients With Recurrent Malignant Gliomas, Primary CNS Lymphoma, or Brain Metastases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00276783|
Recruitment Status : Active, not recruiting
First Posted : January 13, 2006
Last Update Posted : April 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Lymphoma Metastatic Cancer||Drug: pemetrexed||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Alimta (Pemetrexed) in Patients With Recurrent Malignant Gliomas, Primary Central Nervous System Lymphoma, and Brain Metastases|
|Study Start Date :||November 2005|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Treatment Arm
Pemetrexed 900 mg/m2 every 21 days until disease progression.
Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.
- 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. [ Time Frame: Blood and tissue from baseline, then additional blood every 6 weeks while on treatment ]This was optional for patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276783
|United States, Illinois|
|Hematology-Oncology Associates of Illinois|
|Chicago, Illinois, United States, 60611-2998|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Study Chair:||Jeffrey J. Raizer, MD||Robert H. Lurie Cancer Center|