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

National Cancer Institute (NCI)

Status and phase: Terminated; Phase 1

Conditions: Adult Medulloblastoma; Adult Anaplastic Ependymoma; Adult Brain Stem Glioma; Adult Diffuse Astrocytoma; Adult Glioblastoma; Adult Supratentorial Primitive Neuroectodermal Tumor (PNET); Adult Anaplastic Astrocytoma; Adult Ependymoma; Adult Grade II Meningioma; Adult Subependymoma; Adult Oligodendroglioma; Adult Grade I Meningioma; Adult Central Nervous System Germ Cell Tumor; Meningeal Melanocytoma; Adult Gliosarcoma; Adult Pilocytic Astrocytoma; Adult Grade III Meningioma; Adult Ependymoblastoma; Adult Giant Cell Glioblastoma; Adult Pineocytoma; Adult Mixed Glioma; Adult Meningeal Hemangiopericytoma; Adult Choroid Plexus Tumor; Adult Anaplastic Oligodendroglioma; Adult Myxopapillary Ependymoma; Adult Pineoblastoma; Adult Craniopharyngioma

Treatments: Other: pharmacological study; Drug: EF5; Radiation: fluorine F 18 EF5; Procedure: positron emission tomography; Procedure: conventional surgery

Study type: Interventional

Funder types: NIH

Identifiers

NCT00110032

UPCC 01304

NCI-2012-02651

CDR0000423313 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 3 patient groups

Group 1 (fluorine F 18 EF5, PET)

Experimental group

Description:

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

Treatment:

Radiation: fluorine F 18 EF5

Procedure: positron emission tomography

Procedure: conventional surgery

Other: pharmacological study

Group 2 (EF5, PET)

Experimental group

Description:

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

Treatment:

Procedure: positron emission tomography

Procedure: conventional surgery

Other: pharmacological study

Drug: EF5

Group 3 (EF5, PET)

Experimental group

Description:

Patients receive nonradioactive EF5 and \^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.

Treatment:

Radiation: fluorine F 18 EF5

Procedure: positron emission tomography

Procedure: conventional surgery

Other: pharmacological study

Drug: EF5