Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00003282
EF5 in Treating Patients With Solid Tumors
A Phase 1 study testing EF5, therapeutic conventional surgery and biopsy in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors. This phase I trial is studying how well EF5 works in detecting the presence of oxygen in tumor cells in patients with solid tumors that can be biopsied or removed by surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- EF5, therapeutic conventional surgery and biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1998to May 2005
- Phase
- Phase 1
- 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 tumor or highly suspicious cancerous mass based on imaging and clinical signs but not indicative of a direct biopsy/cellular diagnosis preceding surgery
- Must have a clinical condition or physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection
- Performance status - ECOG 0-2
- Life expectancy not specified
- WBC greater than 2,000/mm^3
- Platelet count greater than 100,000/mm^3
Show all 16Show fewer
- Bilirubin less than 2.0 mg/dL
- Creatinine less than 2.0 mg/dL
- Creatinine clearance greater than 50 mL/min
- No significant cardiac disease that would preclude the safe use of general anesthesia
- No significant pulmonary disease that would preclude the safe use of general anesthesia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study
- No history of grade III or IV peripheral neuropathy
- See Disease Characteristics
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: Phase I Trial of EF5, an Agent for the Detection of Hypoxia
Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors. This phase I trial is studying how well EF5 works in detecting the presence of oxygen in tumor cells in patients with solid tumors that can be biopsied or removed by surgery
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the optimal dose of etanidazole derivative EF5 that is safely tolerated and provides optimal signal-to-noise ratio in patients with solid tumors.
II. Determine the toxic effects of EF5 in this patient population. III. Determine the pharmacokinetics of EF5 in this patient population. IV. Determine the dose of EF5 that provides a mean signal-to-noise ratio (maximum binding in anoxia to minimum binding) of 75.
- Determine the relationship between tumor oxygenation by EF5 binding and needle electrode measurements.
VI. Compare the levels of EF5 binding in regions of low and high blood flow.
OUTLINE: This is a dose-escalation study.
Patients receive etanidazole derivative EF5 IV over 1-2 hours beginning approximately 24 hours prior to surgery. Tumors are then resected or biopsied after Eppendorf needle electrode measurements.
Cohorts of 6 patients receive escalating doses of EF5 until the maximum tolerated dose (MTD) or optimal dose is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity. The optimal dose is defined as the dose level at or below the MTD and results in a signal-to-noise ratio of 75 or greater. Thirty additional patients are treated at the optimal dose.
Patients are followed at 30-45 days post EF5 infusion.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
- Being tested
- EF5, therapeutic conventional surgery, biopsy, pharmacological study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EF5Drug
Given IV
therapeutic conventional surgeryProcedure or surgery
Undergo resection
biopsyProcedure or surgery
Also called biopsies
Undergo biopsy
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (EF5) | Experimental | Patients receive etanidazole derivative EF5 IV over 1-2 hours beginning approximately 24 hours prior to surgery. Tumors are then resected or biopsied after Eppendorf needle electrode measurements. Receives: Drug: EF5; Procedure: therapeutic conventional surgery; Procedure: biopsy; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameters including estimation of Cmax, half-life, and area under the time-concentration curve (AUC)
Measured: Pre-dose, 1, 24, and 28 hours
Acute toxicity graded by NCI/DCTDC Common Toxicity Criteria
Measured: Up to 24 hours
Late toxicity graded by NCI/DCTDC Common Toxicity Criteria
Measured: Up to 28 days
Dose-limiting toxicity defined as any grade III or higher toxicity
Measured: Up to 45 days
Acceptable signal-to-noise ratio (75 or above)
Measured: Up to 45 days
Safe and effective dose defined as the dose at which less than 2 of 6 patients have dose-limiting acute or late toxicity and the mean value of signal-to-noise ratio is greater than or equal to 75
Measured: Up to 45 days
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 startMar 1998
- Primary completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT00003282
- Sponsor's protocol ID
- NCI-2012-02266
- Other IDs
- UPCC 7597, R01CA075285, CDR0000066191
- Status last verified
- Jan 2013
- First submitted
- 1 Nov 1999
- 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
- Phase I Trial of EF5, an Agent for the Detection of Hypoxia
- ClinicalTrials.gov ID
- NCT00003282
- Acronym / sponsor ID
- NCI-2012-02266
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 1998
- Primary completion
- May 2005 (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.
Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors. This phase I trial is studying how well EF5 works in detecting the presence of oxygen in tumor cells in patients with solid tumors that can be biopsied or removed by surgery
Detailed description
PRIMARY OBJECTIVES:
- Determine the optimal dose of etanidazole derivative EF5 that is safely tolerated and provides optimal signal-to-noise ratio in patients with solid tumors.
II. Determine the toxic effects of EF5 in this patient population. III. Determine the pharmacokinetics of EF5 in this patient population. IV. Determine the dose of EF5 that provides a mean signal-to-noise ratio (maximum binding in anoxia to minimum binding) of 75.
- Determine the relationship between tumor oxygenation by EF5 binding and needle electrode measurements.
VI. Compare the levels of EF5 binding in regions of low and high blood flow.
OUTLINE: This is a dose-escalation study.
Patients receive etanidazole derivative EF5 IV over 1-2 hours beginning approximately 24 hours prior to surgery. Tumors are then resected or biopsied after Eppendorf needle electrode measurements.
Cohorts of 6 patients receive escalating doses of EF5 until the maximum tolerated dose (MTD) or optimal dose is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity. The optimal dose is defined as the dose level at or below the MTD and results in a signal-to-noise ratio of 75 or greater. Thirty additional patients are treated at the optimal dose.
Patients are followed at 30-45 days post EF5 infusion.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (EF5) | Experimental | Drug: EF5, Procedure: therapeutic conventional surgery, Procedure: biopsy, Other: pharmacological studyPatients receive etanidazole derivative EF5 IV over 1-2 hours beginning approximately 24 hours prior to surgery. Tumors are then resected or biopsied after Eppendorf needle electrode measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed tumor or highly suspicious cancerous mass based on imaging and clinical signs but not indicative of a direct biopsy/cellular diagnosis preceding surgery
- Must have a clinical condition or physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection
- Performance status - ECOG 0-2
- Life expectancy not specified
- WBC greater than 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 |
|---|---|---|
| EF5Given IV | Drug | Diagnostic (EF5) |
| therapeutic conventional surgeryUndergo resection | Procedure or surgery | Diagnostic (EF5) |
| biopsyAlso: biopsiesUndergo biopsy | Procedure or surgery | Diagnostic (EF5) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Diagnostic (EF5) |
Primary outcome
Pharmacokinetics parameters including estimation of Cmax, half-life, and area under the time-concentration curve (AUC)
Time frame: Pre-dose, 1, 24, and 28 hours
Acute toxicity graded by NCI/DCTDC Common Toxicity Criteria
Time frame: Up to 24 hours
Late toxicity graded by NCI/DCTDC Common Toxicity Criteria
Time frame: Up to 28 days
Dose-limiting toxicity defined as any grade III or higher toxicity
Time frame: Up to 45 days
Acceptable signal-to-noise ratio (75 or above)
Time frame: Up to 45 days
Safe and effective dose defined as the dose at which less than 2 of 6 patients have dose-limiting acute or late toxicity and the mean value of signal-to-noise ratio is greater than or equal to 75
Time frame: Up to 45 days
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 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 Phase 1 study testing EF5, therapeutic conventional surgery and biopsy in people with Unspecified Adult Solid Tumor, Protocol Specific, 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 16 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: finished, 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetics parameters including estimation of Cmax, half-life, and area under the time-concentration curve (AUC) (time frame: Pre-dose, 1, 24, and 28 hours). The study lists 6 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.