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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA060553 | U.S. NIH Grant/Contract | View source | |
| NU-05C2 | |||
| STU00007255 | Other Identifier | Northwestern University IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Pemetrexed 900 mg/m2 every 21 days until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival at 6 months and time to disease progression | After every 2 cycles of therapy (1 cycle = 3 weeks) until disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic response | After 6 months of treatment | |
| Collect safety data | After every cycle of therapy (cycle = 3 weeks) until disease progression or death. | |
| Overall survival |
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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:
Effusions or fluid collections must be drained prior to study entry
PATIENT CHARACTERISTICS:
Karnofsky performance score ≥ 60
WBC > 3,000/mm^3
Absolute neutrophil count > 1,500/mm^3
Platelet count > 100,000/mm^3
Hemoglobin > 10 mg/dL (transfusion allowed)
SGOT/SGPT < 3.0 times upper limit of normal (ULN)
Bilirubin < 1.5 times ULN
Creatinine < 1.5 mg/dL
Creatinine clearance > 45 mL/min
Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study and for 3 months after completing study treatment
Women who are pregnant or breast-feeding are not eligible for study treatment
Negative pregnancy test
Able to take steroids, vitamin B12, or folate
No significant medical illnesses or infection that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
Only one active tumor type allowed, except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey J. Raizer, MD | Robert H. Lurie Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology-Oncology Associates of Illinois | Chicago | Illinois | 60611-2998 | United States | ||
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 21, 2023 | |
| Reset | Jan 18, 2024 | |
| Release | Feb 16, 2024 | |
| Reset | Mar 11, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 21, 2023 | Jan 18, 2024 | |||
| Feb 16, 2024 |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D008223 | Lymphoma |
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D005910 | Glioma |
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| 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. | Blood and tissue from baseline, then additional blood every 6 weeks while on treatment |
| Chicago |
| Illinois |
| 60611-3013 |
| United States |
| Mar 11, 2024 |
| D009370 |
| Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |