Photodynamic Therapy (PDT) in Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00984243
First received: December 24, 2007
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

This study is being done to determine whether a substance called hematoporphyrin can be used to treat tumors in various locations in the body when used in association with a laser. Hematoporphyrin is a substance that is taken up by cancerous cells. When these cells are exposed to the energy emitted by a laser source, chemical reactions occur in the cell and cause the cells to die. It is hoped that this treatment method may be able to selectively destroy malignant cells without damaging surrounding healthy tissue.


Condition Intervention
Lung Cancer
Procedure: PHOTODYNAMIC THERAPY (PDT)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Evaluation of the Effectiveness of Photodynamic Therapy (PDT) Compared to Surgical Resection in Early Stage Roentgenographically Occult Lung Cancer.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Evaluate the impact of PDT on these patients by determining the percentage of patients who are spared surgery. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity,overall mortality and lung cancer mortality. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Rate of subsequent lung cancer. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Relative cost of PDT and surgery. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Change in pulmonary function over time. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Effect on quality of life. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Patient preferences for PDT and surgery. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: February 1994
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Photodynamic Therapy
PHOTODYNAMIC THERAPY (PDT)
Procedure: PHOTODYNAMIC THERAPY (PDT)

Photodynamic Procedure:

Photofrin II will be injected at a dosage of 2 mm/Kg intravenously. Laser treatment will take place 40-50 hours later. An argon-dye or an excimer-dye laser tuned to 620-630 nm will be used.

It is anticipated that a microlens fiber will be used in almost all cases, but a cylinder-diffusing fiber can be used to treat lesions in segmental bronchi if needed.

Argon-dye laser: Power settings 200 milliwatt (mW) microlens and 400 mW for cylinder Excimer laser: 4 milliJoules (mJoules)/pulse at 30 hertz for the microlens

Energy density:

Argon-dye laser: 200-300 Joules/cm^2 Excimer-dye laser: 100-200 Joules/cm^2


Detailed Description:

Lung cancer is currently the leading cause of death in both women and men in the United States and continues to be a major problem in several other countries in the world. Detection, localization, and surgical treatment at an early stage, provides the best opportunity for long-term survival for patients with non-sma11 cell lung cancer at this time. Studies examining the utility of screening patients at high risk for lung cancer with sputum cytology and chest roentgenograms showed that, despite a higher frequency of detecting and resecting early cancers in the screened group, there was no difference between the screened group and the control group in overall cancer mortality.

The purpose of this study is to determine if photodynamic therapy (PDT) is an alternative to surgical resection in patients with early stage) roentgenographically occult squamous cell carcinoma of the lung who are candidates for surgery. If PDT is successful, it would remove the indication for surgery and eliminate the need for an operation. The specific goals are to evaluate the impact of PDT on these patients by determining the percentage of patients who are spared surgery as wel1 as the following: morbidity, overall mortality, lung cancer mortality, the rate of subsequent lung cancer, the relative cost of PDT and surgery, the change in pulmonary function over time, the effect on quality of life, and the patient preferences for PDT and surgery.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient less than 75 years of age.
  • Squamous cell lung cancer proven by biopsy or repeated Brushings obtained from the same location at separate bronchoscopies.
  • Occult lung cancer by chest roentgenogram and CT scan If CT scan is abnormal, mediastinoscopy is negative.
  • Cancer is bronchoscopically superficial as defined in section IV, E.
  • Estimated size less than 1 cm diameter on the surface of the bronchus with the surface area of 0.7 to 1.0 cm2.
  • Location in the trachea, main stem bronChi, lobar bronchi, segmental bronchi, or subsegmental bronchi.
  • Medical condition permits surgery: cardiovascular status is satisfactory for operation and postoperative FEVl is predicted to be greater than 0.75 liter.
  • Patients will complete quality of life questionnaire and a spirometry which will include forced expiratory volume in 1 second (FEVl) and forced vital capacity (FVC).
  • On bronchoscopic biopsy, the carcinoma is entirely in situ or shows no more than 2 mm of microinvasion.
  • The characteristics of the mucosa. may include paleness, opacity, loss of luster, roughness, micro-granularity.
  • The mucosal folds may demonstrate lack of clarity. thickening, disappearance.
  • There may be small nodular protrusion of tumor into the lumen
  • The peripheral extent of tumor invasion can be confirmed endoscopically.

Exclusion Criteria:

  • A medical disease which excludes surgery as an option
  • A postoperative FEVl predicted to be less than 0.75 liter
  • A previous carcinoma or other malignancy not curatively treated
  • The presence of simultaneous lung cancers
  • CT scan of the chest shows thickening of the bronchial wall or extension beyond the bronchial wall in the area of the cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984243

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Eric S. Edell, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Eric S. Edell, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00984243     History of Changes
Other Study ID Numbers: 281-92, PulmMed 649
Study First Received: December 24, 2007
Last Updated: November 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014