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

NCT00110032 | Terminated Phase 1

• 3 other identifiers: NCI-2012-02651UPCC 01304CDR0000423313
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

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

  Summarized in descriptive statistics.

  Up to 3 years

Secondary Outcomes (4)

• Pharmacokinetics of radioactively labeled [F-18]-EF5

  Day 1

• Extent of hypoxia, determined by [F-18]-EF5 PET imaging

  Up to day 1

• IHC analysis of cold EF5

  Up to day 1

• Progression-free survival

  Up to 6 years

Study Arms (3)

Group 1 (fluorine F 18 EF5, PET)

EXPERIMENTAL

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.

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

Group 2 (EF5, PET)

EXPERIMENTAL

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

Drug: EF5; Procedure: conventional surgery; Procedure: positron emission tomography; Other: pharmacological study

Group 3 (EF5, PET)

EXPERIMENTAL

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

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

Interventions

EF5 DRUG

Given IV

Group 2 (EF5, PET); Group 3 (EF5, PET)

conventional surgery PROCEDURE

Undergo surgery

Also known as: surgery, conventional

Group 1 (fluorine F 18 EF5, PET); Group 2 (EF5, PET); Group 3 (EF5, PET)

positron emission tomography PROCEDURE

Undergo PET

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Group 1 (fluorine F 18 EF5, PET); Group 2 (EF5, PET); Group 3 (EF5, PET)

fluorine F 18 EF5 RADIATION

Given IV

Also known as: 18F-EF5

Group 1 (fluorine F 18 EF5, PET); Group 3 (EF5, PET)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Group 1 (fluorine F 18 EF5, PET); Group 2 (EF5, PET); Group 3 (EF5, PET)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Astrocytoma; Ependymoma; Oligodendroglioma; Choroid Plexus Neoplasms; Craniopharyngioma; Neuroectodermal Tumors, Primitive; Glioblastoma; Gliosarcoma; Meningioma; Medulloblastoma; Glioma; Pinealoma; Glioma, Subependymal

Interventions

Surgical Procedures, Operative; Congresses as Topic; Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Cerebral Ventricle Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Stephen Michael Hahn

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2005
• First Posted: May 4, 2005
• Study Start: June 1, 2005
• Primary Completion: January 1, 2007
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

US (1)