Clinical trial NCT00433472: MRI in Evaluating the Effect of Efaproxiral on the Brain in Patients With Recurrent or Progressive Glioma Enrolled on Clinical Trial NABTT-9806
Official title: Effect of RSR13 on T2 and T2* Cranial MRI Images: An Imaging Companion Study to NABTT 9806
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Brain and Central Nervous System Tumors
Keywords: adult anaplastic oligodendroglioma
adult giant cell glioblastoma
adult anaplastic astrocytoma
recurrent adult brain tumor
adult glioblastoma
adult gliosarcoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-02-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Measurable effect of efaproxiral on the brain as measured by T2 and/or T2* MRI
measure: Predicted oxygenation changes based on observed T2 MRI changes
measure: Effects of efaproxiral on T2 and T2* MRI relaxation times of normal areas of the brain
measure: Baseline oxygen extraction ratios in tumors
measure: New tumor- or non-tumor-related abnormalities on T2 and T2* MRI
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Larry Kleinberg, MD
role: STUDY_CHAIR
References: