Adult Anaplastic AstrocytomaNCT00430079
Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma
A study testing etanidazole, conventional surgery and pharmacological study in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Ependymoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma
- What is being tested?
- etanidazole, conventional surgery and pharmacological study
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 22Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Assessment of Hypoxia in Malignant Gliomas Using EF5
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
Read the detailed description
PRIMARY 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.
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.
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Diffuse Astrocytoma, Adult Ependymoma, Adult Giant Cell Glioblastoma
- Being tested
- etanidazole, conventional surgery, pharmacological study, laboratory biomarker analysis
- Medical subject headings
- Astrocytoma, Ependymoma, Oligodendroglioma, Glioblastoma, Gliosarcoma, Glioma, Glioma, Subependymal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanidazoleDrug
Also called 2-nitro-imidazole derivative, SR-2508
Given IV
conventional surgeryProcedure or surgery
Also called surgery, conventional
Undergo surgery
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (etanidazole) | Experimental | 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. Receives: Drug: etanidazole; Procedure: conventional surgery; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to local recurrence
Measured: Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years
Secondary outcomes (5)
Time to death
Measured: Up to 3 years
Presence and pattern of EF5 binding in newly diagnosed brain masses by IHC analyses
Measured: At 48 hours after EF5 administration
Levels of EF5 binding within histological subtypes of SMG
Measured: 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 to local recurrence and survival will be estimated by the method of Kaplan and Meier.
Measured: Up to 3 years
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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startJul 2001
- Primary completionSep 2007
Why it stopped: Administratively complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Anaplastic AstrocytomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kevin Judy, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430079
- Sponsor's protocol ID
- NCI-2012-02419
- Other IDs
- UPCC# 1301, R21CA093007, CDR0000068962
- Status last verified
- Jan 2013
- First submitted
- 30 Jan 2007
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hypoxia in Malignant Gliomas Using EF5
- ClinicalTrials.gov ID
- NCT00430079
- Acronym / sponsor ID
- NCI-2012-02419
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Diffuse Astrocytoma, Adult Ependymoma, Adult Giant Cell Glioblastoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 2001
- Primary completion
- Sep 2007 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (etanidazole) | Experimental | Drug: etanidazole, Procedure: conventional surgery, Other: pharmacological study, Other: laboratory biomarker analysisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etanidazoleAlso: 2-nitro-imidazole derivative, SR-2508Given IV | Drug | Diagnostic (etanidazole) |
| conventional surgeryAlso: surgery, conventionalUndergo surgery | Procedure or surgery | Diagnostic (etanidazole) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Diagnostic (etanidazole) |
| laboratory biomarker analysisCorrelative studies | Other | Diagnostic (etanidazole) |
Primary outcome
Time to local recurrence
Time frame: Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years
5 secondary outcomes
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
Association between EF5 binding and Eppendorf needle electrode measurements in brain masses
Time frame: Up to 3 years
Results and safety
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Judy principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing etanidazole, conventional surgery and pharmacological study in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Ependymoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to local recurrence (time frame: Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.