Trial of Photodynamic Therapy Versus Argon Plasma Coagulation for Lung Cancer With Endobronchial Obstruction

University of Florida

Status: Terminated

Conditions: Non Small Cell Lung Cancer

Treatments: Procedure: Argon Plasma Coagulation; Procedure: Photodynamic Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03564054

UF-PDO-THO-1001 (Other Identifier)

UF-THO-001

RGA030 (Other Grant/Funding Number)

OCR17811 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to assess the efficacy of photodynamic therapy (PDT) in relieving airway obstruction in subjects with lung cancer compared to treatment with argon plasma coagulation (APC).

Full description

This is a multi-center, randomized study that will compare the efficacy of photodynamic therapy (PDT) and argon plasma coagulation (APC) in the treatment of airway obstruction caused by non small cell lung cancer. Participants will be randomized in a 1:1 ratio to receive treatment with one of these two treatment modalities.

Enrollment: 3 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.
• Subjects must have a biopsy proven for non-small cell lung cancer with obstructing or partially obstructing endobronchial tumor involving the main stem bronchus or bronchus intermedius, or lobar bronchus with or without extrabronchial tumor.
• Both males and females ≥ eighteen years of age
• Subject must demonstrate at least a 50% airway stenosis due to endobronchial tumor.
• Subject must demonstrate symptoms of cough, hemoptysis, dyspnea etc. attributable to partially or completely occluding endobronchial tumor.
• Subject is able to tolerate multiple bronchoscopies.
• Subjects who were previously treated with chemotherapy or radiotherapy are eligible for study entry. Such subjects must be at least 2 weeks post-radiotherapy and must have recovered from all acute toxicities associated with such treatment.
• A predicted life expectancy of at least 90 days.

Exclusion criteria

• Prior treatment of non-small cell carcinoma with PDT or with APC in the last 3 months.
• Subjects with tracheal lesions or carinal lesions that compromise both main stem bronchi.
• Subjects who have undergone pneumonectomy.
• Tumor involving or eroding into major blood vessels.
• Presence of a tracheoesophageal or bronchoesophageal fistula.
• Subjects receiving concurrent external beam radiation therapy.
• Radiation therapy within the previous two weeks.
• Inability to adhere to sunlight precautions.
• Severe hepatic impairment.
• Severe renal impairment.
• Porphyria or hypersensitivity to porphyrins.
• Subjects requiring supplemental O2 with a flow of greater than 3 lpm to keep resting oxygen saturations greater than 90%.
• History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
• Prisoners or subjects who are involuntarily incarcerated.
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
• Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
• Females who are pregnant.
• Individuals who cannot provide consent themselves.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Photodynamic Therapy

Experimental group

Description:

Photodynamic therapy (PDT) uses activation of a photosensitizer by light of a specific wavelength to generate reactive oxygen species and singlet oxygen that causes direct cell damage and death, apoptosis, tumor vasculature damage and thrombosis, and inflammation leading to an immunological response.Following randomization, subjects will undergo treatment with either PDT or APC. Subjects will then have six additional study visits at 30, 45, 60, 90, and 180 days after their last PDT or APC treatment

Treatment:

Procedure: Photodynamic Therapy

Argon Plasma Coagulation

Experimental group

Description:

Argon plasma coagulation (APC) is a noncontact form of electrocautery. Following randomization, subjects will undergo treatment with either DPT or APC. Subjects will then have six additional study visits at 30, 45, 60, 90, and 180 days after their last PDT or APC treatment.

Treatment:

Procedure: Argon Plasma Coagulation