Mesothelioma Clinical Trials
Photodynamic Therapy in Treating Patients With Malignant
This study is currently
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.
||Treatment or Intervention|
| Drug: porfimer
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
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:
- 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
- Determine the toxic effects of this regimen in these
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
- Histologically or cytologically confirmed malignant
mesothelioma, including the following cell types:
- Mixed mesothelial
- 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
- No adenocarcinoma or nonmesothelioma sarcoma of the