Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

February 25, 2011 updated by: Roswell Park Cancer Institute

Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Combining photodynamic therapy with surgery may be an effective treatment for malignant mesothelioma.

PURPOSE: Phase II trial to study the effectiveness of combining photodynamic therapy with surgery in treating patients who have malignant mesothelioma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the feasibility of adjuvant photodynamic therapy with large diffuser fibers in patients with malignant mesothelioma undergoing surgery.
  • Compare results of this regimen in these patients to historical controls.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a pilot study.

Patients receive porfimer sodium IV over 5-10 minutes on day 1. Patients undergo pleurectomy or pleuropneumonectomy followed by intracavitary photodynamic therapy on day 3.

Patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed malignant mesothelioma, including the following cell types:

    • Mixed mesothelial
    • Sarcomatous
  • Stage I or II disease using the Butchart system as determined by CT scan or MRI
  • Disease confined to 1 hemithorax

  • No tumor involvement of esophagus or heart as evidenced by CT scan

    • Pericardial or diaphragmatic involvement allowed if disease is limited to the ipsilateral chest
    • N2 disease allowed if no contralateral pleural involvement
  • No adenocarcinoma or nonmesothelioma sarcoma of the chest wall

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC greater than 4,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 8.5 g/dL (transfusion allowed)

Hepatic

  • Bilirubin less than 3.0 mg/dL
  • Alkaline phosphatase less than 2 times upper limit of normal (ULN)
  • SGOT less than 2 times ULN

Renal

  • Creatinine less than 3.0 mg/dL

Cardiovascular

  • No myocardial infarction within the past 6 months

Pulmonary

  • Arterial partial pressure of carbon dioxide (pCO_2) less than 50 torr at rest
  • Predicted postoperative FEV_1 at least 800 mL with maximum oxygen consumption/kg at least 15 mL/min
  • Predicted postoperative total lung capacity at least 40% of hemoglobin and alveolar ventilation

Other

  • Not pregnant
  • No other concurrent malignancy except nonmelanoma skin cancer
  • No contraindication to general anesthetic
  • No history of porphyria
  • No indicated sensitivity to porfimer sodium

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 30 days since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the chest
  • No prior radiotherapy for mesothelioma

Surgery

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility
Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years
1 month, every 4 months for 2 years, and then every 6 months for 3 years
Comparison of results from this regimen to historical controls
Time Frame: At completion of study
At completion of study
Toxic effects
Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years
1 month, every 4 months for 2 years, and then every 6 months for 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Study Chair: Todd L. Demmy, MD, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Primary Completion (ACTUAL)

June 1, 2006

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

February 5, 2003

First Submitted That Met QC Criteria

February 5, 2003

First Posted (ESTIMATE)

February 6, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

March 1, 2011

Last Update Submitted That Met QC Criteria

February 25, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000269674
  • RPCI-RP-9812

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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