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Advanced Malignant MesotheliomaNCT00028782

EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer

A study testing etanidazole, therapeutic conventional surgery and laboratory biomarker analysis in people with Advanced Malignant Mesothelioma and Localized Malignant Mesothelioma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
etanidazole, therapeutic conventional surgery and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
Oct 2001to Sep 2007
Phase
Interventional
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 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
Show all 29Show fewer
  • 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
  • Creatinine clearance at least 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after completion of study treatment
  • Weight no more than 130 kg
  • HIV negative
  • Able to tolerate anesthesia or major surgery
  • No grade III or IV peripheral neuropathy
  • No regional enteritis or ulcerative colitis
  • No contraindication for anesthesia or major surgery
  • Prior combination chemotherapy for malignancy allowed
  • No concurrent chemotherapy except for recurrent or persistent disease
  • No concurrent radiotherapy except for recurrent or persistent disease
  • Prior surgery for malignancy allowed

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

Other trials in United States

About this study

Official title: The Detection of Tumor Hypoxia and Vascularity in Patients Undergoing Intraperitoneal Photodynamic Therapy

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

Read the detailed description

OBJECTIVES:

  1. Determine the level of hypoxia through etanidazole derivative EF5 binding in patients with intraperitoneal or pleural malignancies treated with photodynamic therapy.

II. Determine the microvascular density in this patient population. III. Determine the relationships between levels of hypoxia, measures of microvascular density, and photosensitizer levels in this patient population.

IV. Correlate hypoxia and photosensitizer levels with clinical outcome in this patient population.

  1. Determine the toxic effects of EF5 in this patient population.

OUTLINE: This is a multicenter study.

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.

Patients are followed at 2 weeks and at 30-45 days post EF5 infusion.

PROJECTED ACCRUAL: A total of 80 patients (50 with intraperitoneal malignancy and 30 with pleural malignancy) will be accrued for this study within 2.5 years. Patients are stratified by disease (intraperitoneal malignancy vs pleural malignancy).

Being tested
etanidazole, therapeutic conventional surgery, laboratory biomarker analysis
Medical subject headings
Mesothelioma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • etanidazoleDrug

    Also called 2-nitro-imidazole derivative, SR-2508

    Given IV

  • therapeutic conventional surgeryProcedure or surgery

    Undergo surgery

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00028782
Study groupRoleWhat they receive
Diagnostic (etanidazole)ExperimentalPatients 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.
Receives: Drug: etanidazole; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At the completion of surgery

  2. 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).

    Measured: At the completion of surgery

  3. 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.

    Measured: At the completion of surgery

  4. Relationships among levels of hypoxia, microvascular density, and photosensitizer levels

    Measured: At the completion of surgery

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

    Measured: Not Provided

Secondary outcomes (1)

  1. Toxicity of EF5 administration

    All observed toxicities will be graded, tabled for each stratum (IP study) and for the entire study and summarized by frequencies and percentages.

    Measured: Up to 45 days after EF5 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2001
  3. Primary completionSep 2007

Why it stopped: Administratively complete.

Resources

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 N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028782
Sponsor's protocol ID
NCI-2012-02438
Other IDs
UPCC# 05901, P01CA087971, CDR0000069134
Status last verified
Jan 2013
First submitted
4 Jan 2002
Last updated
16 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing etanidazole, therapeutic conventional surgery and laboratory biomarker analysis in people with Advanced Malignant Mesothelioma and Localized Malignant Mesothelioma, 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 29 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: stopped early, 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.

Are results available for this study?

The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.

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?

Level of hypoxia in tumor nodules (time frame: At the completion of surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00028782.

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.

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