Status:
TERMINATED
Positron Emission Tomography Using Fluorine F 18 EF5 to Find Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Newly Diagnosed Brain Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects of fluorine F18 EF5 when given during positron emission tomography to find oxygen in tumor cells of patients who are undergoing surgery or biopsy for ne...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the safety of fluorine F 18 EF5 (\^18F-EF5) in patients with newly diagnosed brain tumors undergoing surgery or biopsy. Secondary I. Determine the pharmacokinetics a...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed and/or clinical and imaging evidence of a de novo mass that is likely to be a brain tumor
- Amenable to debulking surgery or surgical resection or biopsy as standard initial therapy for the tumor
- Performance status - Karnofsky 70-100%
- At least 3 months
- WBC count ≥ 2,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin \< 1.2 mg/dL
- Creatinine \< 1.3 mg/dL
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No other significant cardiac condition that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study participation
- Weight ≤ 130 kg
- No peripheral neuropathy ≥ grade 3
- No history of allergic reaction attributed to metronidazole
- No other uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
- No other medical condition that would preclude study participation
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00110032
Start Date
June 1 2005
Last Update
January 16 2013
Active Locations (1)
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1
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104