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

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

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).
    

Study Type

Interventional

Primary Outcome

Level of hypoxia in tumor nodules

Secondary Outcome

 Toxicity of EF5 administration

Condition

Advanced Malignant Mesothelioma

Intervention

etanidazole

Study Arms / Comparison Groups

 Diagnostic (etanidazole)

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

80

Start Date

October 2001

Primary Completion Date

September 2007

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Stephen Michael Hahn, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00028782

Organization ID

NCI-2012-02438

Secondary IDs

UPCC# 05901

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

Stephen Michael Hahn, Principal Investigator, Abramson Cancer Center of the University of Pennsylvania

Verification Date

January 2013