Clinical Trials

Mesothelioma
Info

Mesothelioma
Prognosis

Mesothelioma
Symptoms

Mesothelioma Settlement

Mesothelioma
Treatments

Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

This study is currently recruiting patients

Sponsored by

Roswell Park Cancer Institute
National Cancer Institute (NCI)

Purpose

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.

MEDLINE plus related topics: Asbestos/Asbestosis; Cancer; Cancer Alternative Therapy; Lung Cancer

Study Type: Interventional

Study Design: Treatment

Official Title: Phase II Pilot Study of Surgery and Adjuvant Intracavitary Photodynamic Therapy With Large Diffuser Fibers in Patients With Malignant Mesothelioma

Further Study Details:

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:

· Ages Eligible for Study: 18 Years and above

· Genders Eligible for Study: both

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

Location and Contact Information

New York
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001,
United States; Recruiting
Timothy M. Anderson, MD 716-845-5873
timothy.anderson@roswellpark.org

Study chairs or principal investigators
Timothy M. Anderson, MD, Study Chair, Roswell Park Cancer Institute

More Information

Study ID Numbers CDR0000269674; RPCI-RP-9812
Record last reviewed January 2003
NLM Identifier NCT00054002
ClinicalTrials.gov processed this record on 2004-01-16

Source: Clinical Trials