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Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00054002
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : March 1, 2011
Sponsor:
Information provided by:
Roswell Park Cancer Institute

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Malignant Mesothelioma Procedure: adjuvant therapy Procedure: conventional surgery Drug: porfimer sodium Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers
Study Start Date : March 1999
Actual Primary Completion Date : June 2006
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arms and Interventions
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Intervention Details:
  • Procedure: adjuvant therapy
    Lung surgery
  • Procedure: conventional surgery
    Lung surgery
  • Drug: porfimer sodium
    iv

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054002


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
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Study Chair: Todd L. Demmy, MD Roswell Park Cancer Institute
More Information
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Responsible Party: Todd Demmy, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00054002    
Other Study ID Numbers: CDR0000269674
RPCI-RP-9812
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: March 1, 2011
Last Verified: February 2011
Keywords provided by Roswell Park Cancer Institute:
localized malignant mesothelioma
recurrent malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma
Additional relevant MeSH terms:
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Mesothelioma
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Dihematoporphyrin Ether
Trioxsalen
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents