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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00463008 |
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.
Condition | Intervention |
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Brain and Central Nervous System Tumors |
Drug: methotrexate Procedure: pharmacological study |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter |
Estimated Enrollment: | 12 |
Study Start Date: | May 2004 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed supratentorial grade III or IV astrocytoma of 1 of the following subtypes:
Undergoing stereotactic biopsy for confirmation of tumor progression or differentiation of tumor progression from treatment-induced effects
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000346432, NABTT-0302, JHOC-NABTT-0302 |
Study First Received: | April 18, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00463008 |
Health Authority: | United States: Federal Government |
adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult glioblastoma |
recurrent adult brain tumor adult gliosarcoma adult giant cell glioblastoma |
Folic Acid Brain Neoplasms Glioblastoma Astrocytoma Methotrexate Oligodendroglioma |
Glioma Central Nervous System Neoplasms Gliosarcoma Recurrence Nervous System Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists |
Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |