Assessment of Hypoxia in Malignant Gliomas Using EF5
Overview
- Phase
- Not Applicable
- Intervention
- etanidazole
- Conditions
- Adult Anaplastic Astrocytoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Time to local recurrence
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: etanidazole
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.
Intervention: conventional surgery
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.
Intervention: pharmacological study
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.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Time to local recurrence
Time Frame: Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years
Secondary Outcomes
- 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 death(Up to 3 years)
- Association between EF5 binding and Eppendorf needle electrode measurements in brain masses(Up to 3 years)
- Levels of EF5 binding within histological subtypes of SMG(At baseline, at 1 hour, and the time of surgery)