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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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

etanidazole

therapeutic conventional surgery

laboratory biomarker analysis

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

NCT ID

NCT00028782

First Posted

January 4, 2002

Last Updated

January 15, 2013

Sponsor

National Cancer Institute (NCI)

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

Advanced Malignant Mesothelioma, Localized Malignant Mesothelioma, Malignant Ascites

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial