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Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma
This study has been completed.
Sponsors and Collaborators: University of Pennsylvania
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00430079
  Purpose

RATIONALE: Diagnostic procedures using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment.

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.


Condition Intervention
Brain and Central Nervous System Tumors
Drug: EF5
Procedure: biopsy
Procedure: conventional surgery
Procedure: immunohistochemistry staining method
Procedure: laboratory biomarker analysis

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Assessment of Hypoxia in Malignant Gliomas Using EF5

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

Primary Outcome Measures:
  • Relationship between hypoxia and clinical outcomes (i.e., time to local recurrence and survival) [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: July 2001
Detailed Description:

OBJECTIVES:

  • 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.
  • 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.
  • Determine the spatial relationships between EF5 binding and tumor tissue biomarkers and pathophysiologic processes (e.g., necrosis, proliferation, and apoptosis) in these patients.
  • 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky performance status 60-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC greater than 2,000/mm^3
  • Platelet count greater than 90,000/mm^3

Hepatic

  • Not specified

Renal

  • Creatinine less than 2.0 mg/dL

Cardiovascular

  • No significant cardiac condition that would preclude study therapy
  • No symptomatic congestive heart failure
  • No unstable angina pectoris

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 6 months since prior chemotherapy

Endocrine therapy:

  • Concurrent corticosteroid therapy allowed

Radiotherapy:

  • At least 6 months since prior radiotherapy to lesion or site of lesion

Surgery:

  • See Disease Characteristics
  • At least 6 months since prior surgery to lesion or site of lesion except incisional or core biopsy

Other:

  • Concurrent anticonvulsant therapy allowed
  • No other concurrent investigational agents
  Contacts and Locations
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, 19104-4283
Sponsors and Collaborators
University of Pennsylvania
Investigators
Study Chair: Kevin Judy, MD University of Pennsylvania
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000068962, UPCC-1301, UPCC-IRB-702859, NCI-4950
Study First Received: January 30, 2007
Last Updated: November 22, 2008
ClinicalTrials.gov Identifier: NCT00430079  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma
adult anaplastic astrocytoma
adult myxopapillary ependymoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult pilocytic astrocytoma
adult subependymoma
adult oligodendroglioma
adult giant cell glioblastoma
adult gliosarcoma
adult ependymoma
adult diffuse astrocytoma
adult pineal gland astrocytoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Glioblastoma
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioma
Central Nervous System Neoplasms
Gliosarcoma
Ependymoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 14, 2009