Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas

NCI-Sponsored Trial for the Evaluation of Safety and Preliminary Efficacy Using [F18] Fluorothymidine (FLT) As a Marker of Proliferation in Patients With Primary Brain Tumors

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.

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.

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