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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

Primary Purpose

Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
etanidazole
conventional surgery
pharmacological study
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adult Anaplastic Astrocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of The University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (etanidazole)

Arm Description

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.

Outcomes

Primary Outcome Measures

Time to local recurrence

Secondary Outcome Measures

Time to death
Presence and pattern of EF5 binding in newly diagnosed brain masses by IHC analyses
Levels of EF5 binding within histological subtypes of SMG
Relationship between hypoxia and clinical outcomes (i.e., time to local recurrence and survival)
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
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.

Full Information

First Posted
January 30, 2007
Last Updated
January 15, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00430079
Brief Title
Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma
Official Title
Assessment of Hypoxia in Malignant Gliomas Using EF5
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
July 2001 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (etanidazole)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
etanidazole
Other Intervention Name(s)
2-nitro-imidazole derivative, SR-2508
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Other Intervention Name(s)
surgery, conventional
Intervention Description
Undergo surgery
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Time to local recurrence
Time Frame
Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years
Secondary Outcome Measure Information:
Title
Time to death
Time Frame
Up to 3 years
Title
Presence and pattern of EF5 binding in newly diagnosed brain masses by IHC analyses
Time Frame
At 48 hours after EF5 administration
Title
Levels of EF5 binding within histological subtypes of SMG
Time Frame
At baseline, at 1 hour, and the time of surgery
Title
Relationship between hypoxia and clinical outcomes (i.e., time to local recurrence and survival)
Description
Time to local recurrence and survival will be estimated by the method of Kaplan and Meier.
Time Frame
Up to 3 years
Title
Association between EF5 binding and Eppendorf needle electrode measurements in brain masses
Description
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.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Judy
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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