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| ID | Type | Description | Link |
|---|---|---|---|
| NABTT-0302 | |||
| JHOC-NABTT-0302 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Collecting fluid from a brain tumor using a small catheter may help doctors learn how much methotrexate gets into the tumor to kill the tumor cells. It may also help doctors learn how methotrexate works in the brain and in the rest of the body.
PURPOSE: This clinical trial is studying how much methotrexate gets into the brain tumor by collecting fluid directly from the tumor through a small catheter in patients undergoing stereotactic biopsy for recurrent high-grade glioma.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients have an intratumoral microdialysis catheter placed while undergoing stereotactic biopsy. Between 18-32 hours after placement of catheter, patients receive methotrexate IV over 4 hours. Microdialysis perfusate and blood specimens are collected before, during, and for 24 hours after methotrexate administration.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 6 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methotrexate | Drug | |||
| pharmacological study | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of methotrexate levels in the brain extracelluar fluid vs in the serum | ||
| Safety and efficacy of the microdialysis catheter |
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DISEASE CHARACTERISTICS:
Histologically confirmed supratentorial grade III or IV astrocytoma of 1 of the following subtypes:
Measurable, contrast-enhancing, residual disease by MRI or CT scan
Undergoing stereotactic biopsy for confirmation of tumor progression or differentiation of tumor progression from treatment-induced effects
Must have received prior radiotherapy with or without chemotherapy
Planning to continue methotrexate therapy after participation on this study
No ascites or pleural effusions
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey J. Olson, MD | Emory University | Study Chair |
| Stuart A. Grossman, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| D005910 |
| Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |