- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003282
EF5 in Treating Patients With Solid Tumors
Phase I Trial of EF5, an Agent for the Detection of Hypoxia
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. 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.
V. 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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic (EF5)
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.
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Correlative studies
Other Names:
Given IV
Undergo resection
Undergo biopsy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Pre-dose, 1, 24, and 28 hours
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Acute toxicity graded by NCI/DCTDC Common Toxicity Criteria
Time Frame: Up to 24 hours
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Up to 24 hours
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Late toxicity graded by NCI/DCTDC Common Toxicity Criteria
Time Frame: Up to 28 days
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Up to 28 days
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Dose-limiting toxicity defined as any grade III or higher toxicity
Time Frame: Up to 45 days
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Up to 45 days
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Acceptable signal-to-noise ratio (75 or above)
Time Frame: Up to 45 days
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Up to 45 days
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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
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Up to 45 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NCI-2012-02266
- UPCC 7597
- R01CA075285 (U.S. NIH Grant/Contract)
- CDR0000066191 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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