Mesothelioma Clinical Trials
EF5 in Detecting Oxygen Level and Blood Vessels in
Tumor Cells of Patients Undergoing Photodynamic Therapy for
Intraperitoneal or Pleural Cancer
This study is currently
recruiting patients.
University of Pennsylvania Cancer
Center
For more information:National
Cancer Institute (NCI)
RATIONALE: Diagnostic procedures using EF5 to detect oxygen
level and blood vessels in tumor cells may help to improve the
way photodynamic therapy is given.
PURPOSE: Clinical trial to study the effectiveness of EF5
in detecting oxygen level and blood vessels in tumor cells of
patients who are undergoing photodynamic therapy for
intraperitoneal or pleural cancer.
| Condition
|
Treatment or
Intervention |
malignant ascites
peritoneal
cavity cancer
advanced malignant
mesothelioma
localized malignant
mesothelioma
recurrent malignant mesothelioma |
Drug: EF5
Procedure: diagnostic
test
Procedure: fluorescent antibody
technique
Procedure: immunohistochemistry
|
This is a Phase II test
- In Phase II clinical trials, the study drug or treatment
is given to a larger group of people (100-300) to see if it
is effective and to further evaluate its safety.
Study Type: Interventional
Study
Design: Diagnostic
Official Title: Study of the Etanidazole
Derivative EF5 for the Detection of Hypoxia and Vascularity in
Patients With Intraperitoneal or Pleural Malignancies Treated
With Photodynamic Therapy
Further Study Details:
OBJECTIVES:
- Determine the level of hypoxia through etanidazole
derivative EF5 binding in patients with intraperitoneal or
pleural malignancies treated with photodynamic therapy.
- Determine the microvascular density in this patient
population.
- Determine the relationships between levels of hypoxia,
measures of microvascular density, and photosensitizer
levels in this patient population.
- Correlate hypoxia and photosensitizer levels with
clinical outcome in this patient population.
- 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 50 patients will be accrued
for this study within 2-3 years.
Ages Eligible for Study: 18 Years and
above, Genders Eligible for Study: Both
DISEASE CHARACTERISTICS:
- 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
| 
