Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Non-Small Cell Lung Cancer And Bronchial Disease
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: porfimer sodium (Drug); bronchoscopy (Procedure)
Sponsored by: Ohio State University Comprehensive Cancer Center
Official(s) and/or principal investigator(s):
Susan Moffatt-Bruce, MD, PhD, Principal Investigator, Affiliation: Ohio State University Comprehensive Cancer Center
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.
Official title: Immunobiology of Photodynamic Therapy in Lung Cancer Patients
Study design: Allocation: Non-Randomized, Primary Purpose: Treatment
Primary outcome: T cell mediated immune response measured by assays of tumor tissue, bronchoalveolar fluid, and plasma
Survival rates at 6 months and 1 year
Correlation between immune response and survival rates at 6 months and 1 year
- To test the hypothesis that the immune response in non-small cell lung cancer patients
treated with photodynamic therapy (PDT) is T cell mediated.
- 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
- 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.
Minimum age: 18 Years.
Maximum age: N/A.
- Diagnosis of non-small cell lung cancer
- Any stage disease with obstructive or hemorrhagic endobronchial disease as determined
- No existing tracheoesophageal or bronchoesophageal fistulas
- No tumor eroding into a major vessel
- 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
Locations and Contacts
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210-1240, United States; Recruiting
Susan Moffatt-Bruce, MD, PhD, Phone: 866-627-7616
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 2008
Last updated: February 2, 2010