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

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ClinicalTrials.gov Identifier: NCT00754910
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : July 5, 2018
Sponsor:
Information provided by (Responsible Party):
Susan Moffatt-Bruce, Ohio State University Comprehensive Cancer Center

Brief 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.


Condition or disease Intervention/treatment
Lung Cancer Drug: porfimer sodium Procedure: bronchoscopy

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.

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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Immunobiology of Photodynamic Therapy in Lung Cancer Patients
Actual Study Start Date : December 2008
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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.
Drug: porfimer sodium
Given IV

Procedure: bronchoscopy
Patients undergo bronchoscopy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
lung cancer patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754910


Locations
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United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Susan Moffatt-Bruce, MD, PhD Ohio State University Comprehensive Cancer Center
Additional Information:
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Responsible Party: Susan Moffatt-Bruce, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00754910    
Other Study ID Numbers: OSU-07115
NCI-2011-03195 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: July 5, 2018
Last Verified: July 2018
Keywords provided by Susan Moffatt-Bruce, Ohio State University Comprehensive Cancer Center:
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
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Dihematoporphyrin Ether
Trioxsalen
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents