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Phase I Trial of EF5, an Agent for the Detection of Hypoxia


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Trial of EF5, an Agent for the Detection of Hypoxia


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Pharmacokinetics parameters including estimation of Cmax, half-life, and area under the time-concentration curve (AUC)

Outcome Time Frame:

Pre-dose, 1, 24, and 28 hours

Safety Issue:

No

Principal Investigator

Stephen Michael Hahn

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02266

NCT ID:

NCT00003282

Start Date:

March 1998

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283