Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma

January 15, 2013 updated by: National Cancer Institute (NCI)

Assessment of Hypoxia in Malignant Gliomas Using EF5

This clinical trial is using EF5 to measure the oxygen level in tumor cells of patients undergoing surgery or surgery biopsy for newly diagnosed supratentorial malignant glioma. Diagnostic procedures using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the presence and pattern of etanidazole derivative EF5 binding with tumor, based on image and cellular analyses, in patients undergoing surgery or biopsy for newly diagnosed supratentorial malignant gliomas.

II. Determine the level of EF5 binding within histologic subtypes of this tumor in these patients.

Compare the relationship between hypoxia and clinical outcomes in patients with glioblastoma multiforme (GBM) vs non-GBM.

III. Determine the spatial relationships between EF5 binding and tumor tissue biomarkers and pathophysiologic processes (e.g., necrosis, proliferation, and apoptosis) in these patients.

IV. Determine the relationship between EF5 binding and Eppendorf needle electrode measurements in these patients.

OUTLINE:

Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers. Fluorescent immunohistochemistry techniques are used to determine the presence, distribution, and levels of EF5 binding.

Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 1½-2 years.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed and/or clinical and imaging evidence of a new brain mass that is likely to be a supratentorial malignant glioma
  • Clinical condition and physiologic status indicative of debulking surgery or biopsy as standard initial therapy
  • Performance status - Karnofsky performance status 60-100%
  • WBC greater than 2,000/mm^3
  • Platelet count greater than 90,000/mm^3
  • Creatinine less than 2.0 mg/dL
  • No significant cardiac condition that would preclude study therapy
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after study completion
  • Weight no greater than 130 kilograms
  • No grade 3 or 4 peripheral neuropathy
  • No other invasive malignancy within the past 3 years that is likely to cause a solitary supratentorial metastasis
  • No uncontrolled concurrent illness, medical condition, psychiatric illness, or social situation that would preclude study participation
  • At least 6 months since prior chemotherapy
  • Concurrent corticosteroid therapy allowed
  • At least 6 months since prior radiotherapy to lesion or site of lesion
  • At least 6 months since prior surgery to lesion or site of lesion except incisional or core biopsy
  • Concurrent anticonvulsant therapy allowed
  • No other concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (etanidazole)
Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers. Fluorescent immunohistochemistry techniques are used to determine the presence, distribution, and levels of EF5 binding.
Correlative studies
Correlative studies
Other Names:
  • pharmacological studies
Given IV
Other Names:
  • 2-nitro-imidazole derivative
  • SR-2508
Undergo surgery
Other Names:
  • surgery, conventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to local recurrence
Time Frame: Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years
Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to death
Time Frame: Up to 3 years
Up to 3 years
Presence and pattern of EF5 binding in newly diagnosed brain masses by IHC analyses
Time Frame: At 48 hours after EF5 administration
At 48 hours after EF5 administration
Levels of EF5 binding within histological subtypes of SMG
Time Frame: At baseline, at 1 hour, and the time of surgery
At baseline, at 1 hour, and the time of surgery
Relationship between hypoxia and clinical outcomes (i.e., time to local recurrence and survival)
Time Frame: Up to 3 years
Time to local recurrence and survival will be estimated by the method of Kaplan and Meier.
Up to 3 years
Association between EF5 binding and Eppendorf needle electrode measurements in brain masses
Time Frame: Up to 3 years
The correlation between median oxygen pressure (pO2) by Eppendorf electrode measurement and percent of maximal signal in tumors (by EF5 binding) will be assessed by Pearson's correlation coefficient.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kevin Judy, Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

September 1, 2007

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

January 30, 2007

First Submitted That Met QC Criteria

January 30, 2007

First Posted (Estimate)

February 1, 2007

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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