MRI in Evaluating the Effect of Efaproxiral on the Brain in Patients With Recurrent or Progressive Glioma Enrolled on Clinical Trial NABTT-9806

Johns Hopkins Medicine

Status: Withdrawn

Conditions: Brain and Central Nervous System Tumors

Treatments: Device: magnetic resonance imaging (MRI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00433472

P30CA006973 (U.S. NIH Grant/Contract)

NABTT-2002

JHOC-NABTT-2002

U01CA062475 (U.S. NIH Grant/Contract)

NABTT-2002 CDR0000274785

ALLOS-RSR13CT-001i

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

0 participants in 1 patient group

MRI -

Other group

Description:

MRI scan to be complete to look at RSR13 on measurement of T2 and T2\* on MRI Procedure/surgery magnetic resonance imaging (MRI)

Treatment:

Device: magnetic resonance imaging (MRI)