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

18 Years
Not Enrolling
Advanced Malignant Mesothelioma, Localized Malignant Mesothelioma, Malignant Ascites, Primary Peritoneal Cavity Cancer, Recurrent Malignant Mesothelioma

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Trial Information

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


I. 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

V. 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).

Inclusion Criteria:

- Histologically confirmed intraperitoneal or pleural malignancy

- Currently enrolled on 1 of 3 photodynamic therapy trials (UPCC-2997, UPCC-4997, or

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Level of hypoxia in tumor nodules

Outcome Description:

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

Outcome Time Frame:

At the completion of surgery

Safety Issue:


Principal Investigator

Stephen Michael Hahn

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Food and Drug Administration

Study ID:




Start Date:

October 2001

Completion Date:

Related Keywords:

  • Advanced Malignant Mesothelioma
  • Localized Malignant Mesothelioma
  • Malignant Ascites
  • Primary Peritoneal Cavity Cancer
  • Recurrent Malignant Mesothelioma
  • Ascites
  • Mesothelioma
  • Peritoneal Neoplasms



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283