Status:
TERMINATED
Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 di...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00430079
Start Date
July 1 2001
Last Update
January 16 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104