Clinical trial NCT00276770: Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain and Central Nervous System Tumors
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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-01-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University Cancer Center at University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Alexander M. Spence, MD
role: STUDY_CHAIR
References:
citation: Spence AM, Muzi M, Link JM, Hoffman JM, Eary JF, Krohn KA. NCI-sponsored trial for the evaluation of safety and preliminary efficacy of FLT as a marker of proliferation in patients with recurrent gliomas: safety studies. Mol Imaging Biol. 2008 Sep;10(5):271-80. doi: 10.1007/s11307-008-0151-6. Epub 2008 Jun 10.