Mesothelioma Clinical Trials
EF5 in Detecting Oxygen Level and Blood Vessels in
Tumor Cells of Patients Undergoing Photodynamic Therapy for
Intraperitoneal or Pleural Cancer
For more information:National
Cancer Institute (NCI)
This study is currently
University of Pennsylvania Cancer
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.
recurrent malignant mesothelioma
Procedure: fluorescent antibody
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
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:
- 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
- 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
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
Patients are followed at 2 weeks and at 30-45 days post EF5
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
- Histologically confirmed intraperitoneal or pleural
- 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
- 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