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
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: EF5 Procedure: conventional surgery Procedure: positron emission tomography Radiation: fluorine F 18 EF5 Other: pharmacological study |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors |
- Safety of F-18-EF5 based on the NCI CTCAE version 3.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]Summarized in descriptive statistics.
- Pharmacokinetics of radioactively labeled [F-18]-EF5 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- Extent of hypoxia, determined by [F-18]-EF5 PET imaging [ Time Frame: Up to day 1 ] [ Designated as safety issue: No ]
- IHC analysis of cold EF5 [ Time Frame: Up to day 1 ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
| Enrollment: | 46 |
| Study Start Date: | June 2005 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1 (fluorine F 18 EF5, PET)
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
Undergo surgery
Other Name: surgery, conventional
Procedure: positron emission tomography
Undergo PET
Other Names:
Radiation: fluorine F 18 EF5
Given IV
Other Name: 18F-EF5
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
|
Experimental: Group 2 (EF5, PET)
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
Given IV
Procedure: conventional surgery
Undergo surgery
Other Name: surgery, conventional
Procedure: positron emission tomography
Undergo PET
Other Names:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
|
Experimental: Group 3 (EF5, PET)
Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.
|
Drug: EF5
Given IV
Procedure: conventional surgery
Undergo surgery
Other Name: surgery, conventional
Procedure: positron emission tomography
Undergo PET
Other Names:
Radiation: fluorine F 18 EF5
Given IV
Other Name: 18F-EF5
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Pennsylvania | |
| Abramson Cancer Center of The University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Stephen Michael Hahn | Abramson Cancer Center of the University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00110032 History of Changes |
| Other Study ID Numbers: | NCI-2012-02651, UPCC 01304, CDR0000423313 |
| Study First Received: | May 3, 2005 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
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 Neoplasms, Neuroepithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Bone Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013