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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Assessment of Hypoxia in Malignant Gliomas Using EF5

Brief Summary: 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

Detailed Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Time to local recurrence [ Time Frame: Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years ]

Original Primary Outcome: Determine the relationship between hypoxia and clinical outcomes (i.e., time to local recurrence and survival)

Current Secondary Outcome:

  • Time to death [ Time Frame: 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 ]
  • Levels of EF5 binding within histological subtypes of SMG [ Time Frame: 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.
  • 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.


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: January 30, 2007
Date Started: July 2001
Date Completion:
Last Updated: January 15, 2013
Last Verified: January 2013