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

This study has been withdrawn prior to enrollment.
(not enough interest)
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00433472
First received: February 8, 2007
Last updated: October 18, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Brain and Central Nervous System Tumors
Procedure: magnetic resonance imaging

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Effect of RSR13 on T2 and T2* Cranial MRI Images: An Imaging Companion Study to NABTT 9806

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Measurable effect of efaproxiral on the brain as measured by T2 and/or T2* MRI [ Designated as safety issue: No ]
  • Predicted oxygenation changes based on observed T2 MRI changes [ Designated as safety issue: No ]
  • Effects of efaproxiral on T2 and T2* MRI relaxation times of normal areas of the brain [ Designated as safety issue: No ]
  • Baseline oxygen extraction ratios in tumors [ Designated as safety issue: No ]
  • New tumor- or non-tumor-related abnormalities on T2 and T2* MRI [ Designated as safety issue: No ]

Estimated Enrollment: 48
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433472

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Larry Kleinberg, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Joy Fisher, ABTC Consortium
ClinicalTrials.gov Identifier: NCT00433472     History of Changes
Other Study ID Numbers: CDR0000274785, U01CA062475, P30CA006973, NABTT-2002, JHOC-NABTT-2002, ALLOS-RSR13CT-001i
Study First Received: February 8, 2007
Last Updated: October 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
adult anaplastic oligodendroglioma
adult giant cell glioblastoma
adult anaplastic astrocytoma
recurrent adult brain tumor
adult glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014