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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014