Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

Roswell Park Comprehensive Cancer Center

Status and phase

Completed

Phase 2

Conditions

Malignant Mesothelioma

Treatments

Procedure: conventional surgery

Drug: porfimer sodium

Procedure: adjuvant therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00054002

CDR0000269674

RPCI-RP-9812

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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