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

Primary Peritoneal Cavity Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00028782
• Other study ID #: NCI-2012-02438
• Secondary ID: UPCC# 05901P01CA
• Status: Terminated
• Phase: N/A
• First received: January 4, 2002
• Last updated: January 15, 2013
• Start date: October 2001

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. Diagnostic procedures using EF5 to detect oxygen level and blood vessels in tumor cells may help to improve the way photodynamic therapy is given

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• etanidazole
Given IV

Procedure:
• therapeutic conventional surgery
Undergo surgery

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the completion of surgery	No
Primary	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).	At the completion of surgery	No
Primary	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.	At the completion of surgery	No
Primary	Relationships among levels of hypoxia, microvascular density, and photosensitizer levels		At the completion of surgery	No
Primary	Associations between hypoxia and photosensitizer levels in tumor nodules with clinical outcome periodically until disease recurrence		Not Provided	No
Secondary	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.	Up to 45 days after EF5 infusion	Yes