Stage I Adult Soft Tissue SarcomaNCT00896961
EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer
A study testing EF5, diagnostic laboratory biomarker analysis and pharmacological study in people with Stage I Adult Soft Tissue Sarcoma and Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This laboratory study is using EF5 to evaluate tumor hypoxia in patients with high-grade soft tissue sarcoma or mouth cancer. 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
- Stage I Adult Soft Tissue Sarcoma, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Adult Soft Tissue Sarcoma
- What is being tested?
- EF5, diagnostic laboratory biomarker analysis and pharmacological study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 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 high-grade soft tissue sarcoma (STS) of the trunk or extremity or squamous cell carcinoma of the oral cavity for which surgical biopsy or resection is standard initial therapy
- Clinical imaging of mass that is likely to be STS or squamous cell carcinoma of the head and neck allowed if surgery is indicated prior to definitive diagnosis
- Planned resection and standard oncologic treatment
- No known distant metastatic disease
- ECOG 0-2
- WBC at least 2,000/mm^3
Show all 20Show fewer
- Platelet count at least 100,000/mm^3
- Bilirubin less than 2.0 mg/dL
- Creatinine less than 2.0 mg/dL OR creatinine clearance at least 50 mL/min
- No significant cardiac condition that would preclude study compliance
- Weight no greater than 130 kg
- No grade III or IV peripheral neuropathy
- No other medical condition that would preclude study compliance
- Not pregnant or nursing
- Fertile patients must use effective contraception
- See Disease Characteristics
- No chemotherapy within 3 months before planned surgery
- Preoperative radiotherapy allowed for STS
- No radiotherapy within 3 months before planned surgery
- 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: Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia
This laboratory study is using EF5 to evaluate tumor hypoxia in patients with high-grade soft tissue sarcoma or mouth cancer. 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 biologically-relevant hypoxia by imaging and cellular analysis of EF5 binding in patients with high-grade soft tissue sarcoma of the trunk or extremity or squamous cell carcinoma of the oral cavity.
II. Determine the spatial relationships between EF5 binding and various tumor tissue markers, pathological processes, and serum plasminogen activator inhibitor-1 in these patients.
III. Correlate EF5 binding with Eppendorf electrode measurement and patient-related factors in these patients.
IV. Determine the adjusted and unadjusted associations between clinical outcome and optimal measures of EF5 binding, patient/tumor characteristics, and biological markers in these patients.
OUTLINE:
Approximately 24-48 hours prior to surgical resection or biopsy, patients receive EF5 IV over no more than 2½ hours. Tissue samples are analyzed by immunohistochemistry for EF5 binding. Blood samples are analyzed for genetic markers and cytokines associated with hypoxia and EF5 concentration.
- Conditions
- Stage I Adult Soft Tissue Sarcoma, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Adult Soft Tissue Sarcoma, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Adult Soft Tissue Sarcoma, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
- Being tested
- EF5, diagnostic laboratory biomarker analysis, pharmacological study
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EF5Drug
diagnostic laboratory biomarker analysisOther
Also called pharmacological studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (EF5) | Experimental | Approximately 24-48 hours prior to surgical resection or biopsy, patients receive EF5 IV over no more than 2½ hours. Tissue samples are analyzed by immunohistochemistry for EF5 binding. Blood samples are analyzed for genetic markers and cytokines associated with hypoxia and EF5 concentration. Receives: Drug: EF5; Other: diagnostic laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to locoregional recurrence in HNSCC patients
Measured: Time from study entry (EF5 administration) to locoregional recurrence, assessed up to 6 years
Time to distant metastasis in STS patients
Measured: Time from study entry (EF5 administration) to distant metastasis, assessed up to 6 years
How rapidly the STS recurred based on the original grade, time to recurrence and the degree of hypoxia in recurrent STS patients
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startAug 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 Stage I Adult Soft Tissue SarcomaStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephen Michael Hahn, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896961
- Sponsor's protocol ID
- NCI-2012-02489
- Other IDs
- UPCC# 3300, CDR0000078671
- Status last verified
- Jan 2013
- First submitted
- 9 May 2009
- 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
- Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia
- ClinicalTrials.gov ID
- NCT00896961
- Acronym / sponsor ID
- NCI-2012-02489
- Conditions
- Stage I Adult Soft Tissue Sarcoma, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Adult Soft Tissue Sarcoma, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Adult Soft Tissue Sarcoma, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 2001
- Primary completion
- Sep 2007 (actual)
- First posted
- 12 May 2009 (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 laboratory study is using EF5 to evaluate tumor hypoxia in patients with high-grade soft tissue sarcoma or mouth cancer. Using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment
Detailed description
PRIMARY OBJECTIVES:
- Determine biologically-relevant hypoxia by imaging and cellular analysis of EF5 binding in patients with high-grade soft tissue sarcoma of the trunk or extremity or squamous cell carcinoma of the oral cavity.
II. Determine the spatial relationships between EF5 binding and various tumor tissue markers, pathological processes, and serum plasminogen activator inhibitor-1 in these patients.
III. Correlate EF5 binding with Eppendorf electrode measurement and patient-related factors in these patients.
IV. Determine the adjusted and unadjusted associations between clinical outcome and optimal measures of EF5 binding, patient/tumor characteristics, and biological markers in these patients.
OUTLINE:
Approximately 24-48 hours prior to surgical resection or biopsy, patients receive EF5 IV over no more than 2½ hours. Tissue samples are analyzed by immunohistochemistry for EF5 binding. Blood samples are analyzed for genetic markers and cytokines associated with hypoxia and EF5 concentration.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (EF5) | Experimental | Drug: EF5, Other: diagnostic laboratory biomarker analysis, Other: pharmacological studyApproximately 24-48 hours prior to surgical resection or biopsy, patients receive EF5 IV over no more than 2½ hours. Tissue samples are analyzed by immunohistochemistry for EF5 binding. Blood samples are analyzed for genetic markers and cytokines associated with hypoxia and EF5 concentration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically confirmed high-grade soft tissue sarcoma (STS) of the trunk or extremity or squamous cell carcinoma of the oral cavity for which surgical biopsy or resection is standard initial therapy
- Planned resection and standard oncologic treatment
- No known distant metastatic disease
- ECOG 0-2
- WBC at least 2,000/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 |
|---|---|---|
| EF5 | Drug | Observational (EF5) |
| diagnostic laboratory biomarker analysis | Other | Observational (EF5) |
| pharmacological studyAlso: pharmacological studies | Other | Observational (EF5) |
Primary outcome
Time to locoregional recurrence in HNSCC patients
Time frame: Time from study entry (EF5 administration) to locoregional recurrence, assessed up to 6 years
Time to distant metastasis in STS patients
Time frame: Time from study entry (EF5 administration) to distant metastasis, assessed up to 6 years
How rapidly the STS recurred based on the original grade, time to recurrence and the degree of hypoxia in recurrent STS patients
Time frame: Up to 6 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.
Stephen Michael Hahn 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 EF5, diagnostic laboratory biomarker analysis and pharmacological study in people with Stage I Adult Soft Tissue Sarcoma and Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, 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 20 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 locoregional recurrence in HNSCC patients (time frame: Time from study entry (EF5 administration) to locoregional recurrence, assessed up to 6 years). The study lists 3 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 16 Jan 2013.