Clinical trial NCT00110032: 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
Official title: Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Adult Anaplastic Oligodendroglioma
Adult Brain Stem Glioma
Adult Central Nervous System Germ Cell Tumor
Adult Choroid Plexus Tumor
Adult Craniopharyngioma
Adult Diffuse Astrocytoma
Adult Ependymoblastoma
Adult Ependymoma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Adult Grade I Meningioma
Adult Grade II Meningioma
Adult Grade III Meningioma
Adult Medulloblastoma
Adult Meningeal Hemangiopericytoma
Adult Mixed Glioma
Adult Myxopapillary Ependymoma
Adult Oligodendroglioma
Adult Pilocytic Astrocytoma
Adult Pineoblastoma
Adult Pineocytoma
Adult Subependymoma
Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)
Meningeal Melanocytoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-05-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 newly diagnosed brain tumors. Diagnostic procedures using fluorine F 18 EF5 and positron emission tomography to detect tumor hypoxia may help in planning cancer treatment

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 and biodistribution of \^18F-EF5 administered before and after nonradioactive EF5 in these patients.

II. Determine the ability of positron emission tomography (PET) scanning using \^18F-EF5 to detect tumor hypoxia in these patients.

III. Determine the presence and pattern of nonradioactive EF5 binding by immunohistochemistry (IHC) and/or flow cytometry in these patients.

IV. Correlate tumor hypoxia, as measured by PET scanning using \^18F-EF5, with EF5 staining by IHC and/or flow cytometry and recurrence-free survival of these patients.

OUTLINE: Patients are assigned to 1 of 3 groups.

Group 1: Patients receive fluorine F 18 EF5 (\^18F-EF5) IV followed by whole brain and whole body positron emission tomography (PET) scanning OR whole body PET scanning only. Patients then receive nonradioactive EF5 IV over 1-2 ½ hours.

Group 2: Patients receive nonradioactive EF5 IV over 1-2½ hours followed by \^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning.

Group 3: Patients receive nonradioactive EF5 and \^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning. Approximately one day after EF5 administration, all patients undergo surgery or biopsy of the tumor AND biopsy of normal skin adjacent to the incision.

Patients are followed at 2-4 weeks and 4-6 weeks after EF5 administration and then every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of F-18-EF5 based on the NCI CTCAE version 3.0
timeFrame: Up to 3 years
Secondary outcomes:
measure: Pharmacokinetics of radioactively labeled [F-18]-EF5
timeFrame: Day 1
measure: Extent of hypoxia, determined by [F-18]-EF5 PET imaging
timeFrame: Up to day 1
measure: IHC analysis of cold EF5
timeFrame: Up to day 1
measure: Progression-free survival
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of The University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Stephen Michael Hahn
role: PRINCIPAL_INVESTIGATOR
References: