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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00276783 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Lymphoma Metastatic Cancer |
Drug: pemetrexed |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Alimta (Pemetrexed) in Patients With Recurrent Malignant Gliomas, Primary Central Nervous System Lymphoma, and Brain Metastases |
| Enrollment: | 31 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment Arm
Pemetrexed 900 mg/m2 every 21 days until disease progression.
|
Drug: pemetrexed
Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.
Other Names:
|
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Malignant glioma, including the following subtypes: glioblastoma or gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, or malignant glioma not otherwise specified, meeting the following criteria:
Primary CNS lymphoma, meeting the following criteria:
Brain metastases from a solid tumor, meeting the following criteria:
PATIENT CHARACTERISTICS:
Only one active tumor type allowed, except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Jeffrey J. Raizer, Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00276783 History of Changes |
| Other Study ID Numbers: | NU 05C2, P30CA060553, NU-05C2 |
| Study First Received: | January 12, 2006 |
| Last Updated: | May 19, 2011 |
| Health Authority: | United States: Federal Government |
|
primary central nervous system lymphoma tumors metastatic to brain recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma |
adult mixed glioma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult glioblastoma |
|
Glioma Lymphoma Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Neoplastic Processes Pathologic Processes Neoplasms by Site Nervous System Diseases Pemetrexed Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |