Head and Neck CancerPhase 2NCT00049140
EF5 Compared With Other Methods of Detecting Oxygen Levels in Tumor Cells of Patients With Head and Neck Cancer
A Phase 2 study testing EF5, bioluminescence and flow cytometry in people with Head and Neck Cancer, run by David M. Brizel, MD at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors. PURPOSE: Phase II trial to compare diagnostic procedures using EF5 to that of other methods of detecting oxygen levels in tumor cells of patients who have head and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- EF5, bioluminescence and flow cytometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Oct 2004
- Phase
- Phase 2
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the head and neck
- Clinically detectable disease by physical examination or radiographic studies
- Scheduled to undergo surgical resection of tumor or radiotherapeutic treatment
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- WBC greater than 3,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
Renal
- Creatinine no greater than 1.8 mg/dL
Other
- No allergy to IV contrast dye
- No prior grade III or IV peripheral neuropathy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 week after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- Concurrent radiotherapy allowed
Surgery
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
About this study
Official title: Pilot Study of the Relationship Between EF5 Uptake and Concentration of Oxygen-Related Metabolites in Head and Neck Cancer
RATIONALE: Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors.
PURPOSE: Phase II trial to compare diagnostic procedures using EF5 to that of other methods of detecting oxygen levels in tumor cells of patients who have head and neck cancer.
Read the detailed description
OBJECTIVES:
- Determine the distribution, degree, and intrapatient and interpatient heterogeneity of hypoxia, as measured by EF5 binding in tumor tissue, in patients with head and neck cancer.
- Determine the distribution and intrapatient and interpatient heterogeneity of CA9 expression, as measured immunohistochemically, in these patients.
- Determine the distribution, concentration, and intrapatient and interpatient heterogeneity of glucose and lactate, as measured by bioluminescence imaging, in these patients.
- Determine whether there is spatial coordination between concentrations of lactate and glucose and the location of tissue hypoxia in these patients.
- Determine whether there is spatial coordination between the location of CA9 with hypoxia and/or lactate concentrations in these patients.
OUTLINE: Patients receive EF5 IV over 1-2.5 hours on day 1. Within 24-55 hours after EF5 infusion, patients undergo surgery.
Tumor tissue samples are examined for EF5 binding by immunohistochemistry, bioluminescence imaging, and flow cytometry.
Patients are followed at 1 month and then for survival.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 1 year.
- Conditions
- Head and Neck Cancer
- Being tested
- EF5, bioluminescence, flow cytometry, immunohistochemistry staining method, biopsy
- Keywords
- stage I squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the paranasal sinus and nasal cavity, stage II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EF5Drug
bioluminescenceOther
flow cytometryOther
biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| EF5 | Experimental | This is a non randomised single arm pilot study. Receives: Drug: EF5; Other: bioluminescence; Other: flow cytometry; Other: immunohistochemistry staining method; Procedure: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual
Measured: One Year
Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual
Measured: One year
Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual
Measured: One Year
Spatial coordination as measured by EF5 binding at completion of accrual
Measured: One Year
Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2002
- Primary completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- David M. Brizel, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, David M. Brizel, MD, Duke University
- Investigators
- David M. Brizel, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049140
- Sponsor's protocol ID
- CDR0000257828
- Other IDs
- DUMC-3512-02-3, NCI-5929
- Status last verified
- Feb 2013
- First submitted
- 12 Nov 2002
- Last updated
- 25 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Relationship Between EF5 Uptake and Concentration of Oxygen-Related Metabolites in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00049140
- Acronym / sponsor ID
- CDR0000257828
- Conditions
- Head and Neck Cancer
- Keywords
- stage I squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the paranasal sinus and nasal cavity, stage II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- David M. Brizel, MDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2002
- Primary completion
- Oct 2004 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors.
PURPOSE: Phase II trial to compare diagnostic procedures using EF5 to that of other methods of detecting oxygen levels in tumor cells of patients who have head and neck cancer.
Detailed description
OBJECTIVES:
- Determine the distribution, degree, and intrapatient and interpatient heterogeneity of hypoxia, as measured by EF5 binding in tumor tissue, in patients with head and neck cancer.
- Determine the distribution and intrapatient and interpatient heterogeneity of CA9 expression, as measured immunohistochemically, in these patients.
- Determine the distribution, concentration, and intrapatient and interpatient heterogeneity of glucose and lactate, as measured by bioluminescence imaging, in these patients.
- Determine whether there is spatial coordination between concentrations of lactate and glucose and the location of tissue hypoxia in these patients.
- Determine whether there is spatial coordination between the location of CA9 with hypoxia and/or lactate concentrations in these patients.
OUTLINE: Patients receive EF5 IV over 1-2.5 hours on day 1. Within 24-55 hours after EF5 infusion, patients undergo surgery.
Tumor tissue samples are examined for EF5 binding by immunohistochemistry, bioluminescence imaging, and flow cytometry.
Patients are followed at 1 month and then for survival.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EF5 | Experimental | Drug: EF5, Other: bioluminescence, Other: flow cytometry, Other: immunohistochemistry staining method, Procedure: biopsyThis is a non randomised single arm pilot study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| EF5 | Drug | EF5 |
| bioluminescence | Other | EF5 |
| flow cytometry | Other | EF5 |
| immunohistochemistry staining method | Other | EF5 |
| biopsy | Procedure or surgery | EF5 |
Primary outcome
Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual
Time frame: One Year
Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual
Time frame: One year
Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual
Time frame: One Year
Spatial coordination as measured by EF5 binding at completion of accrual
Time frame: One Year
Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
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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.
David M. Brizel, MD study chair
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EF5, bioluminescence and flow cytometry in people with Head and Neck Cancer, run by David M. Brizel, MD 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?
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: finished, as of the sponsor's last update on 25 Jul 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual (time frame: One Year). The study lists 5 primary outcomes in all. 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 25 Jul 2014.