Clinical trial NCT00028782: EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer
Official title: The Detection of Tumor Hypoxia and Vascularity in Patients Undergoing Intraperitoneal Photodynamic Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Advanced Malignant Mesothelioma
Localized Malignant Mesothelioma
Malignant Ascites
Primary Peritoneal Cavity Cancer
Recurrent Malignant Mesothelioma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed description: OBJECTIVES:

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 population.

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).

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Level of hypoxia in tumor nodules
timeFrame: At the completion of surgery
measure: Inter- and intra-patient variability of hypoxia by EF5 binding
timeFrame: At the completion of surgery
measure: Levels of microvascular density by PECAM/CD31 staining
timeFrame: At the completion of surgery
measure: Relationships among levels of hypoxia, microvascular density, and photosensitizer levels
timeFrame: At the completion of surgery
measure: Associations between hypoxia and photosensitizer levels in tumor nodules with clinical outcome periodically until disease recurrence
timeFrame: Not Provided
Secondary outcomes:
measure: Toxicity of EF5 administration
timeFrame: Up to 45 days after EF5 infusion
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of The University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Stephen Michael Hahn
role: PRINCIPAL_INVESTIGATOR
References: