Brain and Central Nervous System Tumors
Conditions
Keywords
adult anaplastic astrocytoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult diffuse astrocytoma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma, adult ependymoma, adult oligodendroglioma, recurrent adult brain tumor, adult mixed glioma
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 is studying how well positron emission tomography using fluorothymidine F 18 works in finding recurrent disease in patients with gliomas.
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. Secondary * Compare, preliminarily, the efficacy of this drug to fludeoxyglucose F 18 in differentiating tumor recurrence from radiation necrosis. * Determine the optimal time to image post injection of this drug. OUTLINE: This is a pilot, nonrandomized study. Patients receive fluorothymidine F 18 IV over 1 minute and then undergo positron emission tomography (PET) scanning of the brain over 2 hours. After completion of the PET scan, patients are followed for at least 1 month. PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
Interventions
PROCEDUREpositron emission tomography
Sponsors
National Cancer Institute (NCI)
University of Washington
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed