Brain and Central Nervous System Tumors
Conditions
Keywords
adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult glioblastoma, adult gliosarcoma
Brief summary
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.
Detailed description
OBJECTIVES: * Determine whether efaproxiral has a measurable effect on the brain as shown by T2 and/or T2\* MRI in patients with recurrent or progressive malignant glioma enrolled on NABTT-9806. * Determine predicted oxygenation changes based on observed T2 MRI changes in these patients. * Determine the effects of this drug on T2 and T2\* MRI relaxation times of normal areas of the brain in these patients. * Determine baseline oxygen extraction ratios in tumors of patients treated with this drug. * Determine whether administration of this drug reveals any new tumor- or non-tumor-related abnormalities on T2 and T2\* MRI in these patients. 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.
Interventions
DEVICEmagnetic resonance imaging (MRI)
MRI scan to be complete to look at RSR13 on measurement of T2 and T2\* on MRI
Sponsors
National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Recurrent or progressive glioma * Currently enrolled on clinical trial NABTT-9806 PATIENT CHARACTERISTICS: * No severe claustrophobia * No cardiac pacemaker * No MRI-incompatible metallic implant PRIOR CONCURRENT THERAPY: * Not specified
Design outcomes
Primary
| Measure | 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 | — |
Outcome results
None listed