Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Non-Small Cell Lung Cancer And Bronchial Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | December 2008 |
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.
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.
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.
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.
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)
We found this trial at
1
site
300 West 10th Avenue, Suite 519
Columbus, Ohio 43210
Columbus, Ohio 43210
614-293-5066
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University...
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