Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma
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| ClinicalTrials.gov Identifier: NCT00430079 |
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Recruitment Status :
Terminated
(Administratively complete.)
First Posted : February 1, 2007
Last Update Posted : January 16, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 48 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Assessment of Hypoxia in Malignant Gliomas Using EF5 |
| Study Start Date : | July 2001 |
| Actual Primary Completion Date : | September 2007 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: etanidazole
Given IV
Other Names:
Procedure: conventional surgery Undergo surgery
Other Name: surgery, conventional Other: pharmacological study Correlative studies
Other Name: pharmacological studies Other: laboratory biomarker analysis Correlative studies |
- Time to local recurrence [ Time Frame: Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years ]
- Time to death [ Time Frame: Up to 3 years ]
- Presence and pattern of EF5 binding in newly diagnosed brain masses by IHC analyses [ Time Frame: At 48 hours after EF5 administration ]
- Levels of EF5 binding within histological subtypes of SMG [ Time Frame: At baseline, at 1 hour, and the time of surgery ]
- Relationship between hypoxia and clinical outcomes (i.e., time to local recurrence and survival) [ Time Frame: Up to 3 years ]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 ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430079
| United States, Pennsylvania | |
| Abramson Cancer Center of The University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Kevin Judy | Abramson Cancer Center of the University of Pennsylvania |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00430079 History of Changes |
| Other Study ID Numbers: |
NCI-2012-02419 UPCC# 1301 R21CA093007 ( U.S. NIH Grant/Contract ) CDR0000068962 ( Registry Identifier: PDQ (Physician Data Query) ) |
| First Posted: | February 1, 2007 Key Record Dates |
| Last Update Posted: | January 16, 2013 |
| Last Verified: | January 2013 |
Additional relevant MeSH terms:
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Glioblastoma Glioma Astrocytoma Ependymoma Gliosarcoma 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 |