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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA062475 | U.S. NIH Grant/Contract | View source | |
| P30CA006973 | U.S. NIH Grant/Contract | View source | |
| NABTT-2002 | |||
| JHOC-NABTT-2002 | |||
| ALLOS-RSR13CT-001i |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Diagnostic procedures, such as MRI, may help doctors learn how efaproxiral works in the brain and help plan the best treatment.
PURPOSE: This clinical trial is using MRI to evaluate the effect of efaproxiral on the brain in patients with recurrent or progressive glioma receiving treatment on clinical trial NABTT-9806.
OBJECTIVES:
OUTLINE: This is an open-label, multicenter, pilot study.
Patients receive efaproxiral and carmustine on clinical trial NABTT-9806. During any one course of treatment on that study, patients undergo MRI before oxygen administration (baseline), before efaproxiral infusion, and then every 5 minutes until 1 hour after efaproxiral and carmustine treatment. Data is evaluated for extent and intensity of T2/T2* changes and oxygen concentration changes in both abnormal and normal brain.
PROJECTED ACCRUAL: A total of 15-48 patients will be accrued for this study within 12-24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI - | Other | MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI Procedure/surgery magnetic resonance imaging (MRI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnetic resonance imaging (MRI) | Device | MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurable effect of efaproxiral on the brain as measured by T2 and/or T2* MRI | ||
| Predicted oxygenation changes based on observed T2 MRI changes | ||
| Effects of efaproxiral on T2 and T2* MRI relaxation times of normal areas of the brain | ||
| Baseline oxygen extraction ratios in tumors | ||
| New tumor- or non-tumor-related abnormalities on T2 and T2* MRI |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Larry Kleinberg, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009837 | Oligodendroglioma |
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| D001932 | Brain Neoplasms |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| 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 |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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