Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00054002
First received: February 5, 2003
Last updated: February 25, 2011
Last verified: February 2011

February 5, 2003
February 25, 2011
March 1999
June 2006   (final data collection date for primary outcome measure)
  • Feasibility [ Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years ] [ Designated as safety issue: No ]
  • Comparison of results from this regimen to historical controls [ Time Frame: At completion of study ] [ Designated as safety issue: No ]
  • Toxic effects [ Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00054002 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Mesothelioma
  • Procedure: adjuvant therapy
    Lung surgery
  • Procedure: conventional surgery
    Lung surgery
  • Drug: porfimer sodium
    iv
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2010
June 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00054002
CDR0000269674, RPCI-RP-9812
Yes
Todd Demmy, MD, Roswell Park Cancer Institute
Roswell Park Cancer Institute
Not Provided
Study Chair: Todd L. Demmy, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP