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

This study has been terminated.
(Administratively complete.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00430079
First Posted: February 1, 2007
Last Update Posted: January 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
January 30, 2007
February 1, 2007
January 16, 2013
July 2001
September 2007   (Final data collection date for primary outcome measure)
Time to local recurrence [ Time Frame: Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years ]
Determine the relationship between hypoxia and clinical outcomes (i.e., time to local recurrence and survival)
Complete list of historical versions of study NCT00430079 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma
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

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Ependymoma
  • Adult Anaplastic Oligodendroglioma
  • Adult Diffuse Astrocytoma
  • Adult Ependymoma
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Adult Mixed Glioma
  • Adult Myxopapillary Ependymoma
  • Adult Oligodendroglioma
  • Adult Pilocytic Astrocytoma
  • Adult Pineal Gland Astrocytoma
  • Adult Subependymoma
  • Drug: etanidazole
    Given IV
    Other Names:
    • 2-nitro-imidazole derivative
    • SR-2508
  • Procedure: conventional surgery
    Undergo surgery
    Other Name: surgery, conventional
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
  • Other: laboratory biomarker analysis
    Correlative studies
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.
Interventions:
  • Drug: etanidazole
  • Procedure: conventional surgery
  • Other: pharmacological study
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
48
Not Provided
September 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00430079
NCI-2012-02419
UPCC# 1301
R21CA093007 ( U.S. NIH Grant/Contract )
CDR0000068962 ( Registry Identifier: PDQ (Physician Data Query) )
Not Provided
Not Provided
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Kevin Judy Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP