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Immunobiology of Photodynamic Therapy in Lung Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Immunobiology of Photodynamic Therapy in Lung Cancer Patients


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

T cell mediated immune response measured by assays of tumor tissue, bronchoalveolar fluid, and plasma

Safety Issue:

No

Principal Investigator

Susan Moffatt-Bruce, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

Unspecified

Study ID:

CDR0000614438

NCT ID:

NCT00754910

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Bronchial Diseases
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240