Clinical trial NCT00054002: Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Mesothelioma
Keywords: localized malignant mesothelioma
recurrent malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2003-02-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Feasibility
timeFrame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years
measure: Comparison of results from this regimen to historical controls
timeFrame: At completion of study
measure: Toxic effects
timeFrame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Todd L. Demmy, MD
role: STUDY_CHAIR
References: