Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma - Full Text View

Sponsor:	Roswell Park Cancer Institute
Information provided by:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00054002

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.

Condition	Intervention	Phase
Malignant Mesothelioma	Procedure: adjuvant therapy Procedure: conventional surgery Drug: porfimer sodium	Phase II

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma

Drug Information available for: Porfimer sodium Dihematoporphyrin ether Trioxsalen

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:

Feasibility [ Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years ] [ Designated as safety issue: No ]
Comparison of results from this regimen to historical controls [ Time Frame: At completion of study ] [ Designated as safety issue: No ]
Toxic effects [ Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years ] [ Designated as safety issue: Yes ]

Enrollment:	12
Study Start Date:	March 1999
Study Completion Date:	December 2010
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Lung surgery

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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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054002

Locations

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators

Study Chair:

Todd L. Demmy, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Todd Demmy, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00054002 History of Changes
Other Study ID Numbers:	CDR0000269674, RPCI-RP-9812
Study First Received:	February 5, 2003
Last Updated:	February 25, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:

localized malignant mesothelioma
recurrent malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma

Additional relevant MeSH terms:

Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Trioxsalen
Dihematoporphyrin Ether

Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012