search
Back to results

Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

Primary Purpose

Malignant Mesothelioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
adjuvant therapy
conventional surgery
porfimer sodium
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Mesothelioma focused on measuring localized malignant mesothelioma, recurrent malignant mesothelioma, epithelial mesothelioma, sarcomatous mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Feasibility
Comparison of results from this regimen to historical controls
Toxic effects

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
February 25, 2011
Sponsor
Roswell Park Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00054002
Brief Title
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

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Mesothelioma
Keywords
localized malignant mesothelioma, recurrent malignant mesothelioma, epithelial mesothelioma, sarcomatous mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Description
Lung surgery
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
Lung surgery
Intervention Type
Drug
Intervention Name(s)
porfimer sodium
Intervention Description
iv
Primary Outcome Measure Information:
Title
Feasibility
Time Frame
1 month, every 4 months for 2 years, and then every 6 months for 3 years
Title
Comparison of results from this regimen to historical controls
Time Frame
At completion of study
Title
Toxic effects
Time Frame
1 month, every 4 months for 2 years, and then every 6 months for 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd L. Demmy, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

We'll reach out to this number within 24 hrs