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

NCT ID: NCT00028782

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31

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).

Conditions

Advanced Malignant Mesothelioma; Localized Malignant Mesothelioma; Malignant Ascites; Primary Peritoneal Cavity Cancer; Recurrent Malignant Mesothelioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (etanidazole)

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.

Group Type: EXPERIMENTAL

etanidazole

Intervention Type: DRUG

Given IV

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo surgery

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

etanidazole

Given IV

Intervention Type: DRUG

therapeutic conventional surgery

Undergo surgery

Intervention Type: PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

2-nitro-imidazole derivative; SR-2508

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Michael Hahn

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC# 05901

Identifier Type: -

Identifier Source: secondary_id

P01CA087971

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000069134

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02438

Identifier Type: -

Identifier Source: org_study_id