Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
This study has been completed.
Sponsor:
Roswell Park Cancer Institute
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00054002
First received: February 5, 2003
Last updated: February 25, 2011
Last verified: February 2011
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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 2 |
| 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:
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:
Detailed Description:
-
Procedure: adjuvant therapy
Lung surgery
Procedure: conventional surgery
Lung surgery
Drug: porfimer sodium
iv
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:
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 May 19, 2013