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CompletedNCT00054002Updated Mar 1, 2011

Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

A Phase 2 interventional study of adjuvant therapy and conventional surgery in Malignant Mesothelioma, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-01.

Sponsored by Roswell Park Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malignant Mesothelioma

Keywords

  • localized malignant mesothelioma
  • recurrent malignant mesothelioma
  • epithelial mesothelioma
  • sarcomatous mesothelioma
03

In context

Mesothelioma

470 studies on the registry are indexed under Mesothelioma; 75 are open to participants now.

This study's enrollment of 12 is below the median of 40 across 371 interventional studies indexed under Mesothelioma.

Browse Mesothelioma studies →

Lead sponsor

Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Interventions

  • Procedureadjuvant therapy

    Lung surgery

  • Procedureconventional surgery

    Lung surgery

  • Drugporfimer sodium

    iv

06

What researchers measure

Primary outcomes

  1. Feasibility

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

  2. Comparison of results from this regimen to historical controls

    Time frame: At completion of study

  3. Toxic effects

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

07

Study locations

1 site
  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00054002
Lead sponsor
Roswell Park Cancer Institute
First posted
Feb 6, 2003
Start date
Mar 1999
Primary completion
Jun 2006
Completion
Dec 2010
Last update
Mar 1, 2011

Study contacts

Todd L. Demmy, MD
study chair · Roswell Park Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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