Trials / Unknown
UnknownNCT00276783
Pemetrexed Disodium in Treating Patients With Recurrent Malignant Gliomas, Primary CNS Lymphoma, or Brain Metastases
A Phase II Trial of Alimta (Pemetrexed) in Patients With Recurrent Malignant Gliomas, Primary Central Nervous System Lymphoma, and Brain Metastases
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Northwestern University · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pemetrexed | Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression. |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
- First posted
- 2006-01-13
- Last updated
- 2020-03-05
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00276783. Inclusion in this directory is not an endorsement.