NCT00028782

Brief Summary

This phase II trial is studying how well EF5 works in detecting oxygen level and blood vessels in tumor cells of patients who are undergoing photodynamic therapy for intraperitoneal or pleural cancer. Diagnostic procedures using EF5 to detect oxygen level and blood vessels in tumor cells may help to improve the way photodynamic therapy is given

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

5.9 years

First QC Date

January 4, 2002

Last Update Submit

January 15, 2013

Conditions

Advanced Malignant MesotheliomaLocalized Malignant MesotheliomaMalignant AscitesPrimary Peritoneal Cavity CancerRecurrent Malignant Mesothelioma

Outcome Measures

Primary Outcomes (5)

  • Level of hypoxia in tumor nodules

    Exploratory techniques will be used to describe patterns of EF5 binding as well as MVD within and among patients.

    At the completion of surgery

  • Inter- and intra-patient variability of hypoxia by EF5 binding

    Inter- and intra-subject variability can be estimated using summary statistics (standard deviations, or the range of data).

    At the completion of surgery

  • Levels of microvascular density by PECAM/CD31 staining

    Distributions of the four EF5 binding variables and MVD will be examined graphically we anticipate that certain variables may have a Poisson distribution.

    At the completion of surgery

  • Relationships among levels of hypoxia, microvascular density, and photosensitizer levels

    At the completion of surgery

  • Associations between hypoxia and photosensitizer levels in tumor nodules with clinical outcome periodically until disease recurrence

    Not Provided

Secondary Outcomes (1)

  • Toxicity of EF5 administration

    Up to 45 days after EF5 infusion

Study Arms (1)

Diagnostic (etanidazole)

EXPERIMENTAL

Patients receive etanidazole derivative EF5 IV over 1-2 hours. Approximately 48 hours after EF5 administration, patients with intraperitoneal tumors undergo surgical resection. Patients with pleural tumors undergo surgical resection approximately 24 hours after EF5 administration. Tumors are then analyzed for EF5 binding and microvascular density by immunohistochemistry and fluorescent antibody techniques.

Drug: etanidazoleProcedure: therapeutic conventional surgeryOther: laboratory biomarker analysis

Interventions

etanidazoleDRUG

Given IV

Also known as: 2-nitro-imidazole derivative, SR-2508
Diagnostic (etanidazole)
therapeutic conventional surgeryPROCEDURE

Undergo surgery

Diagnostic (etanidazole)
laboratory biomarker analysisOTHER

Correlative studies

Diagnostic (etanidazole)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed intraperitoneal or pleural malignancy
  • Currently enrolled on 1 of 3 photodynamic therapy trials (UPCC-2997, UPCC-4997, or UPCC-05503)
  • Plan to undergo surgery for treatment on one of these protocols
  • Patients with suspected recurrent disease undergoing surgery for diagnosis and debulking allowed if frozen section shows malignant disease
  • No active extra-abdominal metastatic disease and/or intrahepatic involvement secondary to metastatic carcinoma
  • No borderline tumors of low malignant potential
  • No abdominal disease that cannot be debulked to less than 5 mm residual disease in maximal dimension
  • Performance status - ECOG 0-2
  • WBC at least 2,000/mm\^3
  • Platelet count greater than 100,000/mm\^3
  • Bilirubin less than 1.5 mg/dL
  • No severe liver disease
  • No cirrhosis
  • No grade III or IV elevations in liver function studies
  • Creatinine no greater than upper limit of normal
  • +14 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

Conditions

Mesothelioma, Malignant

Interventions

Etanidazole

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Stephen Michael Hahn

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2002

First Posted

January 27, 2003

Study Start

October 1, 2001

Primary Completion

September 1, 2007

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)