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Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Safety of F-18-EF5 based on the NCI CTCAE version 3.0

Outcome Description:

Summarized in descriptive statistics.

Outcome Time Frame:

Up to 3 years

Safety Issue:

Yes

Principal Investigator

Stephen Michael Hahn

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02651

NCT ID:

NCT00110032

Start Date:

June 2005

Completion Date:

Related Keywords:

  • 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
  • Astrocytoma
  • Brain Neoplasms
  • Craniopharyngioma
  • Adamantinoma
  • Ependymoma
  • Glioblastoma
  • Glioma
  • Hemangiopericytoma
  • Medulloblastoma
  • Meningioma
  • Oligodendroglioma
  • Pinealoma
  • Choroid Plexus Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Glioma, Subependymal
  • Gliosarcoma

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283