Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

Malignant Mesothelioma Clinical Trial

Official title:

Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054002
• Other study ID #: CDR0000269674
• Secondary ID: RPCI-RP-9812
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2003
• Last updated: February 25, 2011
• Start date: March 1999
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2010
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma

Intervention

Procedure:
• adjuvant therapy
Lung surgery
• conventional surgery
Lung surgery

Drug:
• porfimer sodium
iv

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility		1 month, every 4 months for 2 years, and then every 6 months for 3 years	No
Primary	Comparison of results from this regimen to historical controls		At completion of study	No
Primary	Toxic effects		1 month, every 4 months for 2 years, and then every 6 months for 3 years	Yes