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CompletedNCT00754910Updated Jul 5, 2018

Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Non-Small Cell Lung Cancer And Bronchial Disease

An observational study in Lung Cancer, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-05.

Sponsored by Ohio State University Comprehensive Cancer Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
35
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against non-small cell lung cancer.

PURPOSE: This clinical trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with non-small cell lung cancer and bronchial disease.

Read the detailed description

OBJECTIVES:

Primary

  • To test the hypothesis that the immune response in non-small cell lung cancer patients treated with photodynamic therapy (PDT) is T cell mediated.

Secondary

  • To test the hypothesis that PDT potentially affects survival rates in these patients.
  • To test the hypothesis that T lymphocytes mediate an immune response that affects survival in PDT treated patients.

OUTLINE: Patients deemed suitable for photodynamic therapy (PDT) are offered PDT. Patients are divided into 2 groups according to whether or not they receive PDT. All patients are referred to radiation and medical oncology for standard of care adjuvant therapy (beginning after completion of this study).

  • Group 1 (PDT): Patients receive porfimer sodium IV over 3-5 minutes and undergo irradiation with red light 48 hours later. Patients receive 2 more treatments at 2-day intervals.
  • Group 2 (non-PDT): Patients undergo a baseline bronchoscopy and a repeat bronchoscopy at 4 weeks.

Blood sample, bronchoalveolar lavage fluid, and tumor tissue are collected after each treatment (group 1) or at time of each bronchoscopy (group 2) and assayed for the presence of lymphocyte phenotypes Th1, Th2, Treg, and Th17. After completion of study therapy, patients are followed at 1 month after PDT and then every 3 months for 3 years.

02

Conditions studied

  • Lung Cancer

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Keywords

  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 35 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) 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
Sampling method
Probability sample

Study population

lung cancer patients

Inclusion criteria

  • Patients that have a diagnosis of non-small cell lung cancer, of any stage, with obstructive or hemorrhagic endobronchial disease receiving PDT treatment.

Exclusion criteria

Exclusion Criteria:

  • Patients that have undergone PDT, chemotherapy or radiation therapy within the past 3 months will not be considered for enrollment.
  • Patients taking antioxidant therapy will be excluded from enrollment due to potential interaction with the potential oxidative mechanism of action of Photofrin®. These antioxidants would include beta-carotene, lutein, Lycopene, Selenium, Vitamin A, Vitamin C, Vitamin E.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
35 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1

    Patients receive porfimer sodium IV over 3-5 minutes and undergo irradiation with red light 48 hours later. Patients receive 2 more treatments at 2-day intervals.

    Drug: porfimer sodium · Procedure: bronchoscopy

Interventions

  • Drugporfimer sodium

    Given IV

  • Procedurebronchoscopy

    Patients undergo bronchoscopy

06

What researchers measure

Primary outcomes

  1. Determine the cytokine phenotype found in collected specimens of lung cancer patients treated with photodynamic therapy.

    Tumor tissue, broncheoalveolar fluid and blood from enrolled patients will be assayed for the presence of the following defined lymphocyte phenotypes

    Time frame: up to one year

Secondary outcomes

  1. Correlate the cytokine phenotype of patients undergoing PDT treatment with survival

    The immune response that is established will be statistically correlated with the survival rate measured at 6 months and 1 year. This will allow us to discern if a higher survival rate is associated with a specific immune response.

    Time frame: up to one year

07

Study locations

1 site
  • Ohio State University Medical Center
    Columbus, Ohio 43210-1240, United States
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00754910
Lead sponsor
Ohio State University Comprehensive Cancer Center
Responsible party
Susan Moffatt-Bruce (Principal Investigator, Ohio State University Comprehensive Cancer Center) — Principal investigator
First posted
Sep 18, 2008
Start date
Dec 2008
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Jul 5, 2018

Study contacts

Susan Moffatt-Bruce, MD, PhD
principal investigator · Ohio State University Comprehensive Cancer Center

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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