Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma
- Conditions
- Adult GlioblastomaAdult GliosarcomaAdult Mixed GliomaAdult Anaplastic EpendymomaAdult EpendymomaAdult Giant Cell GlioblastomaAdult Pilocytic AstrocytomaAdult Pineal Gland AstrocytomaAdult Anaplastic OligodendrogliomaAdult Diffuse Astrocytoma
- Interventions
- Procedure: conventional surgeryOther: pharmacological studyOther: laboratory biomarker analysis
- Registration Number
- NCT00430079
- Lead Sponsor
- National Cancer Institute (NCI)
- 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 48
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic (etanidazole) 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. Diagnostic (etanidazole) laboratory biomarker analysis 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. Diagnostic (etanidazole) conventional surgery 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. Diagnostic (etanidazole) pharmacological study 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.
- Primary Outcome Measures
Name Time Method Time to local recurrence Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years
- Secondary Outcome Measures
Name Time Method Presence and pattern of EF5 binding in newly diagnosed brain masses by IHC analyses At 48 hours after EF5 administration Relationship between hypoxia and clinical outcomes (i.e., time to local recurrence and survival) Up to 3 years Time to local recurrence and survival will be estimated by the method of Kaplan and Meier.
Time to death Up to 3 years Association between EF5 binding and Eppendorf needle electrode measurements in brain masses 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.
Levels of EF5 binding within histological subtypes of SMG At baseline, at 1 hour, and the time of surgery
Trial Locations
- Locations (1)
Abramson Cancer Center of The University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States