Status:
COMPLETED
Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
RATIONALE: Diagnostic procedures, such as positron emission tomography using fluorothymidine F 18, may be effective in finding recurrent disease in patients with gliomas. PURPOSE: This clinical trial...
Detailed Description
OBJECTIVES: Primary * Determine the safety of fluorothymidine F 18 for visual and dynamic brain tumor images in patients with glial neoplasms. * Determine, preliminarily, the efficacy of this drug. ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Radiological or established histological diagnosis of glioma
- WHO grade 2-4 disease
- Presence of a new or enlarging enhancing lesion on gadolinium-enhanced MRI after prior radiotherapy
- Differentiation of recurrent tumor from radiation necrosis is not possible
- No clinically significant signs of uncal herniation, including any of the following:
- Acute pupillary enlargement
- Rapidly developing (i.e., over hours) motor changes
- Rapidly decreasing level of consciousness
- PATIENT CHARACTERISTICS:
- Platelet count ≥ 75,000/mm\^3
- WBC ≥ 3,000/mm\^3
- Gamma-glutamyl-transferase ≤ 5 times upper limit of normal (ULN)
- Absolute neutrophil count ≥ 1,500/mm\^3
- Hemoglobin ≥ 10 g/dL
- SGOT and SGPT ≤ 2 times ULN
- Alkaline phosphatase ≤ 2 times ULN
- Lactic dehydrogenase ≤ 2 times ULN
- Direct and total bilirubin normal
- Amylase normal
- Haptoglobin normal
- Serum electrolytes normal
- CBC with platelets normal
- PT, PTT normal
- BUN and creatinine normal
- Not pregnant or lactating
- Urinalysis normal
- Negative pregnancy test
- Female patients must be postmenopausal for ≥ 1 year or surgically sterile, or on 1 of the following methods of birth control for ≥ 1 month: IUD, oral contraceptives, Depo-Provera, or Norplant
- These criteria can be waived at the discretion of the investigator if the patient's intracranial tumor is considered life threatening and the 1-month wait required is not in the best interest of the patient
- No known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals
- No known HIV positivity
- Not requiring monitored anesthesia for positron emission tomography scanning
- PRIOR CONCURRENT THERAPY:
- Concurrent biopsy or neurosurgical procedure for diagnostic and/or therapeutic purposes for this cancer allowed
- Concurrent surgery for this cancer allowed
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00276770
Start Date
February 1 2006
Last Update
February 27 2019
Active Locations (1)
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1
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043