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Mesothelioma Clinical Trials

Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

This study is currently recruiting patients.

Sponsored by

Roswell Park Cancer Institute
For more information:National Cancer Institute (NCI)

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 Treatment or Intervention
localized malignant mesothelioma
recurrent malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma
 Drug: porfimer sodium
 Procedure: adjuvant therapy
 Procedure: conventional surgery
 Procedure: laser therapy
 Procedure: photodynamic therapy
 Procedure: phototherapy
 Procedure: surgery

This is a Phase II test

  • In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.  

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Pilot Study of Surgery and Adjuvant Intracavitary Photodynamic Therapy With Large Diffuser Fibers in Patients With Malignant Mesothelioma

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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


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