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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00754910
First received: September 17, 2008
Last updated: February 2, 2010
Last verified: June 2009
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Immunobiology of Photodynamic Therapy in Lung Cancer Patients

Resource links provided by NLM:


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
Experimental: 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
Active Comparator: Group 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Susan Moffatt-Bruce, MD, PhD    866-627-7616      
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Susan Moffatt-Bruce, MD, PhD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Susan Moffatt-Bruce, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00754910     History of Changes
Other Study ID Numbers: CDR0000614438, OSU-07115, OSU-2008C0055
Study First Received: September 17, 2008
Last Updated: February 2, 2010
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Trioxsalen
Dihematoporphyrin Ether
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014