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

Primary Purpose

Advanced Malignant Mesothelioma, Localized Malignant Mesothelioma, Malignant Ascites

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
etanidazole
therapeutic conventional surgery
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Advanced Malignant Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of The University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (etanidazole)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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).
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.
Relationships among levels of hypoxia, microvascular density, and photosensitizer levels
Associations between hypoxia and photosensitizer levels in tumor nodules with clinical outcome periodically until disease recurrence

Secondary Outcome Measures

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.

Full Information

First Posted
January 4, 2002
Last Updated
January 15, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00028782
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
October 2001 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Malignant Mesothelioma, Localized Malignant Mesothelioma, Malignant Ascites, Primary Peritoneal Cavity Cancer, Recurrent Malignant Mesothelioma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (etanidazole)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
etanidazole
Other Intervention Name(s)
2-nitro-imidazole derivative, SR-2508
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Undergo surgery
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Level of hypoxia in tumor nodules
Description
Exploratory techniques will be used to describe patterns of EF5 binding as well as MVD within and among patients.
Time Frame
At the completion of surgery
Title
Inter- and intra-patient variability of hypoxia by EF5 binding
Description
Inter- and intra-subject variability can be estimated using summary statistics (standard deviations, or the range of data).
Time Frame
At the completion of surgery
Title
Levels of microvascular density by PECAM/CD31 staining
Description
Distributions of the four EF5 binding variables and MVD will be examined graphically we anticipate that certain variables may have a Poisson distribution.
Time Frame
At the completion of surgery
Title
Relationships among levels of hypoxia, microvascular density, and photosensitizer levels
Time Frame
At the completion of surgery
Title
Associations between hypoxia and photosensitizer levels in tumor nodules with clinical outcome periodically until disease recurrence
Time Frame
Not Provided
Secondary Outcome Measure Information:
Title
Toxicity of EF5 administration
Description
All observed toxicities will be graded, tabled for each stratum (IP study) and for the entire study and summarized by frequencies and percentages.
Time Frame
Up to 45 days after EF5 infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Michael Hahn
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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

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