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

/Home/Lung Cancer Healthcare and Treatment/Lung Cancer Clinical Trials/Non Small Cell Lung Cancer Clinical Trials

Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Non-Small Cell Lung Cancer And Bronchial Disease
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00754910

Purpose
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 Intervention
Lung Cancer
Drug: porfimer sodium
Procedure: bronchoscopy




MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Porfimer sodium Dihematoporphyrin ether Trioxsalen
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized
Official Title: Immunobiology of Photodynamic Therapy in Lung Cancer Patients


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
T cell mediated immune response measured by assays of tumor tissue, bronchoalveolar fluid, and plasma [ Designated as safety issue: No ]



Secondary Outcome Measures:
Survival rates at 6 months and 1 year [ Designated as safety issue: No ]

Correlation between immune response and survival rates at 6 months and 1 year [ Designated as safety issue: No ]


Estimated Enrollment: 236
Study Start Date: December 2008
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Group 1: Experimental
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
Group 2: Active Comparator
Patients undergo a baseline bronchoscopy and a repeat bronchoscopy at 4 weeks. Procedure: bronchoscopy
Patients undergo 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.

PROJECTED ACCRUAL: A total of 236 patients (177 undergoing photodynamic therapy [PDT] and 59 not undergoing PDT) will be accrued for this study.

Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Diagnosis of non-small cell lung cancer
Any stage disease with obstructive or hemorrhagic endobronchial disease as determined by bronchoscopy
No existing tracheoesophageal or bronchoesophageal fistulas
No tumor eroding into a major vessel
PATIENT CHARACTERISTICS:

No known porphyria or allergy to porphyrins
PRIOR CONCURRENT THERAPY:

See disease characteristics
No prior photodynamic therapy, chemotherapy, or radiotherapy
No concurrent antioxidant therapy or dietary supplements
Not initiating chemotherapy or radiotherapy during the study time (1 month post diagnostic bronchoscopy)
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754910


Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Susan Moffatt-Bruce, MD, PhD 866-627-7616

Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Susan Moffatt-Bruce, MD, PhD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Responsible Party: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center ( Susan Moffatt-Bruce )
Study ID Numbers: CDR0000614438, OSU-07115, OSU-2008C0055
Study First Received: September 17, 2008
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00754910 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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



Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Bronchial Diseases
Dihematoporphyrin Ether
Lung Neoplasms
Lung Diseases
Trioxsalen
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Photosensitizing Agents
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions



ClinicalTrials.gov processed this record on February 10, 2009


Back to top of Main Content


U.S. National Library of Medicine, Contact Help Desk
U.S. National Institutes of Health, U.S. Department of Health & Human Services,
USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act