NCT00003282

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

7.2 years

First QC Date

November 1, 1999

Last Update Submit

January 15, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (6)

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

    Pre-dose, 1, 24, and 28 hours

  • Acute toxicity graded by NCI/DCTDC Common Toxicity Criteria

    Up to 24 hours

  • Late toxicity graded by NCI/DCTDC Common Toxicity Criteria

    Up to 28 days

  • Dose-limiting toxicity defined as any grade III or higher toxicity

    Up to 45 days

  • Acceptable signal-to-noise ratio (75 or above)

    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

    Up to 45 days

Study Arms (1)

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.

Drug: EF5Procedure: therapeutic conventional surgeryProcedure: biopsyOther: pharmacological study

Interventions

EF5DRUG

Given IV

Diagnostic (EF5)
therapeutic conventional surgeryPROCEDURE

Undergo resection

Diagnostic (EF5)
biopsyPROCEDURE

Undergo biopsy

Also known as: biopsies
Diagnostic (EF5)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Diagnostic (EF5)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Stephen Michael Hahn

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

March 1, 1998

Primary Completion

May 1, 2005

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)