- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00430079
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
Study Overview
Status
Conditions
- 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
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
Given IV
Other Names:
Undergo surgery
Other Names:
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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
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Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to death
Time Frame: Up to 3 years
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Up to 3 years
|
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Presence and pattern of EF5 binding in newly diagnosed brain masses by IHC analyses
Time Frame: At 48 hours after EF5 administration
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At 48 hours after EF5 administration
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Levels of EF5 binding within histological subtypes of SMG
Time Frame: At baseline, at 1 hour, and the time of surgery
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At baseline, at 1 hour, and the time of surgery
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Relationship between hypoxia and clinical outcomes (i.e., time to local recurrence and survival)
Time Frame: Up to 3 years
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Time to local recurrence and survival will be estimated by the method of Kaplan and Meier.
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Up to 3 years
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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.
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Up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kevin Judy, Abramson Cancer Center of the University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Glioma
- Ependymoma
- Astrocytoma
- Gliosarcoma
- Oligodendroglioma
- Glioma, Subependymal
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Imidazole
- Etanidazole
Other Study ID Numbers
- NCI-2012-02419
- UPCC# 1301
- R21CA093007 (U.S. NIH Grant/Contract)
- CDR0000068962 (Registry Identifier: PDQ (Physician Data Query))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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