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


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Mesothelioma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Feasibility

Outcome Time Frame:

1 month, every 4 months for 2 years, and then every 6 months for 3 years

Safety Issue:

No

Principal Investigator

Todd L. Demmy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000269674

NCT ID:

NCT00054002

Start Date:

March 1999

Completion Date:

December 2010

Related Keywords:

  • Malignant Mesothelioma
  • localized malignant mesothelioma
  • recurrent malignant mesothelioma
  • epithelial mesothelioma
  • sarcomatous mesothelioma
  • Mesothelioma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263