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

Adult Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00110032
• Other study ID #: NCI-2012-02651
• Secondary ID: UPCC 01304CDR000
• Status: Terminated
• Phase: Phase 1
• First received: May 3, 2005
• Last updated: January 15, 2013
• Start date: June 2005

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• 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)
• Astrocytoma
• Choroid Plexus Neoplasms
• Craniopharyngioma
• Ependymoma
• Glioblastoma
• Glioma
• Gliosarcoma
• Hemangiopericytoma
• Medulloblastoma
• Meningeal Melanocytoma
• Meningioma
• Neoplasms
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Oligodendroglioma
• Solitary Fibrous Tumors

Intervention

Drug:
• EF5
Given IV

Procedure:
• conventional surgery
Undergo surgery
• positron emission tomography
Undergo PET

Radiation:
• fluorine F 18 EF5
Given IV

Other:
• pharmacological study
Correlative studies

Locations

Country	Name	City	State
United States	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of F-18-EF5 based on the NCI CTCAE version 3.0	Summarized in descriptive statistics.	Up to 3 years	Yes
Secondary	Pharmacokinetics of radioactively labeled [F-18]-EF5		Day 1	No
Secondary	Extent of hypoxia, determined by [F-18]-EF5 PET imaging		Up to day 1	No
Secondary	IHC analysis of cold EF5		Up to day 1	No
Secondary	Progression-free survival		Up to 6 years	No