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

July 3, 2018 updated by: Susan Moffatt-Bruce, Ohio State University Comprehensive Cancer Center

Immunobiology of Photodynamic Therapy in Lung Cancer Patients

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

lung cancer patients

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Given IV
Patients undergo bronchoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the cytokine phenotype found in collected specimens of lung cancer patients treated with photodynamic therapy.
Time Frame: up to one year
Tumor tissue, broncheoalveolar fluid and blood from enrolled patients will be assayed for the presence of the following defined lymphocyte phenotypes
up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlate the cytokine phenotype of patients undergoing PDT treatment with survival
Time Frame: up to one year
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.
up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susan Moffatt-Bruce, MD, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2008

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 17, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Actual)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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