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Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

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.

Tracking Information
First Received DateFebruary 5, 2003
Last Changed DateFebruary 25, 2011
Start DateMarch 1999
Actual Primary Completion DateJune 2006
Primary Outcome Measures

Feasibility [Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years]

Comparison of results from this regimen to historical controls [Time Frame: At completion of study]

Toxic effects [Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Malignant Mesothelioma
Intervention
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Drug: porfimer sodium
Study Arms / Comparison Groups1 / 0
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.

Recruitment Information
Recruitment StatusCompleted
Actual Enrollment12
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
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

Administrative Information
NCTIDNCT00054002
Responsible PartyTodd Demmy, MD, Roswell Park Cancer Institute
SponsorRoswell Park Cancer Institute
Verification DateFebruary 2011
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