Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma - Full Text View

Purpose

This clinical trial is using EF5 to measure the oxygen level in tumor cells of patients undergoing surgery or surgery biopsy for newly diagnosed supratentorial malignant glioma. Diagnostic procedures using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment

Condition	Intervention
Adult Anaplastic Astrocytoma Adult Anaplastic Ependymoma Adult Anaplastic Oligodendroglioma Adult Diffuse Astrocytoma Adult Ependymoma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Mixed Glioma Adult Myxopapillary Ependymoma Adult Oligodendroglioma Adult Pilocytic Astrocytoma Adult Pineal Gland Astrocytoma Adult Subependymoma	Drug: etanidazole Procedure: conventional surgery Other: pharmacological study Other: laboratory biomarker analysis


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Assessment of Hypoxia in Malignant Gliomas Using EF5

Resource links provided by NLM:

MedlinePlus related topics: Biopsy

Genetic and Rare Diseases Information Center resources: Glioblastoma Oligodendroglioma Glioma Anaplastic Astrocytoma Anaplastic Oligodendroglioma Gliosarcoma Ependymoma Anaplastic Ependymoma Pilocytic Astrocytoma Diffuse Astrocytoma Subependymoma Myxopapillary Ependymoma Neuroepithelioma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Time to local recurrence [ Time Frame: Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to death [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Presence and pattern of EF5 binding in newly diagnosed brain masses by IHC analyses [ Time Frame: At 48 hours after EF5 administration ] [ Designated as safety issue: No ]
Levels of EF5 binding within histological subtypes of SMG [ Time Frame: At baseline, at 1 hour, and the time of surgery ] [ Designated as safety issue: No ]
Relationship between hypoxia and clinical outcomes (i.e., time to local recurrence and survival) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Time to local recurrence and survival will be estimated by the method of Kaplan and Meier.
Association between EF5 binding and Eppendorf needle electrode measurements in brain masses [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
The correlation between median oxygen pressure (pO2) by Eppendorf electrode measurement and percent of maximal signal in tumors (by EF5 binding) will be assessed by Pearson's correlation coefficient.


Enrollment:	48
Study Start Date:	July 2001
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Diagnostic (etanidazole) Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers. Fluorescent immunohistochemistry techniques are used to determine the presence, distribution, and levels of EF5 binding.	Drug: etanidazole Given IV Other Names: 2-nitro-imidazole derivative SR-2508 Procedure: conventional surgery Undergo surgery Other Name: surgery, conventional Other: pharmacological study Correlative studies Other Name: pharmacological studies Other: laboratory biomarker analysis Correlative studies

Arms

Assigned Interventions

Experimental: Diagnostic (etanidazole)

Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers. Fluorescent immunohistochemistry techniques are used to determine the presence, distribution, and levels of EF5 binding.

Drug: etanidazole

Given IV

Other Names:

2-nitro-imidazole derivative
SR-2508

Procedure: conventional surgery

Undergo surgery

Other Name: surgery, conventional

Other: pharmacological study

Correlative studies

Other Name: pharmacological studies

Other: laboratory biomarker analysis

Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the presence and pattern of etanidazole derivative EF5 binding with tumor, based on image and cellular analyses, in patients undergoing surgery or biopsy for newly diagnosed supratentorial malignant gliomas.

II. Determine the level of EF5 binding within histologic subtypes of this tumor in these patients.

Compare the relationship between hypoxia and clinical outcomes in patients with glioblastoma multiforme (GBM) vs non-GBM.

III. Determine the spatial relationships between EF5 binding and tumor tissue biomarkers and pathophysiologic processes (e.g., necrosis, proliferation, and apoptosis) in these patients.

IV. Determine the relationship between EF5 binding and Eppendorf needle electrode measurements in these patients.

OUTLINE:

Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers. Fluorescent immunohistochemistry techniques are used to determine the presence, distribution, and levels of EF5 binding.

Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 1½-2 years.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed and/or clinical and imaging evidence of a new brain mass that is likely to be a supratentorial malignant glioma
Clinical condition and physiologic status indicative of debulking surgery or biopsy as standard initial therapy
Performance status - Karnofsky performance status 60-100%
WBC greater than 2,000/mm^3
Platelet count greater than 90,000/mm^3
Creatinine less than 2.0 mg/dL
No significant cardiac condition that would preclude study therapy
No symptomatic congestive heart failure
No unstable angina pectoris
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 1 month after study completion
Weight no greater than 130 kilograms
No grade 3 or 4 peripheral neuropathy
No other invasive malignancy within the past 3 years that is likely to cause a solitary supratentorial metastasis
No uncontrolled concurrent illness, medical condition, psychiatric illness, or social situation that would preclude study participation
At least 6 months since prior chemotherapy
Concurrent corticosteroid therapy allowed
At least 6 months since prior radiotherapy to lesion or site of lesion
At least 6 months since prior surgery to lesion or site of lesion except incisional or core biopsy
Concurrent anticonvulsant therapy allowed
No other concurrent investigational agents

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430079

Locations


United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Kevin Judy	Abramson Cancer Center of the University of Pennsylvania

More Information


Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00430079 History of Changes
Other Study ID Numbers:	NCI-2012-02419 UPCC# 1301 R21CA093007 CDR0000068962
Study First Received:	January 30, 2007
Last Updated:	January 15, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Glioblastoma Glioma Astrocytoma Gliosarcoma Ependymoma Oligodendroglioma Glioma, Subependymal Neoplasms, Neuroepithelial	Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Etanidazole Antineoplastic Agents

ClinicalTrials.gov processed this record on September 23, 2016