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Protocol No. UW16104

Principal Investigator Ferguson, John

Phase Pilot/Feasibility

Age Group Adult

Scope National

Sponsor Type Industry

Title A Multicenter, Prospective, Open-Label, Single-Arm Clinical Study of the Safety and Feasibility of Using Navigational Bronchoscopy to Perform Interstitial Photodynamic Therapy Using Photofrin as Treatment in Subjects with Unresectable Stage IA Peripheral Non-Small Cell Lung Cancer (NSCLC)

Objective The study aims to assess the safety and possibility of using navigational bronchoscopy to deliver Interstitial Photodynamic therapy (iPDT) to subjects with peripheral NSCLC, that cannot be operated on, who are not candidates for radiation therapy, and/or have refused surgery or radiation therapy. Also, the study will evaluate the overall safety and effectiveness of iPDT in subjects with peripheral NSCLC by reviewing tumor response and exploring how iPDT affects the immune system.

Treatment Interstitial Photodynamic therapy (iPDT) is a treatment now being used in patients with certain types of cancer (namely lung cancer and esophageal cancer). It uses a combination of a photosensitizing drug (a drug that is activated by light), porfimer sodium, and light from a laser that emits no heat. This technique works to allow your study doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. An iPDT course involves the intravenous injection of porfimer sodium lasting 3 to 5 minutes at the standard dose of 2 mg/kg, based on your weight. Forty to fifty hours after this injection, your study doctor will insert a miniature ultrasound probe (Radial EBUS Probe) through a flexible bronchoscope, a device used to look at the inside of the airways and the lungs. This provides your study doctor with a three-dimensional "roadmap" to dal tissue, with the intent of destroying it.

Description You will receive a one-time administration of PHOTOFRIN® which is given as an IV injection lasting 3-5 minutes. Your vital signs will be monitored for 8 hours after the injection. You will return between 40-50 hours after you received the PHOTOFRIN injection for the iPDT bronchoscopy procedure and activation of the portimer sodium using the light. You will be admitted to the hospital for approximately 48-72 hours for an evaluation period when you receive the PHOTOFRIN. You will be on the study approximately 6 and a half months. You would attend a total of 8-10 visits and you will have one 15-minute phone call visit.

Key Eligibility
  • Male or female subject is eighteen years of age and older
  • Subject is diagnosed with peripheral NSCLC histologically confirmed Stage IA (T1aN0M0) NSCLC (such as adenocarcinoma, carcinoids, squamous cell carcinoma, large cell carcinoma, NOS [not otherwise specified], etc.) located in the peripheral lung
  • Subject is not a candidate for curative surgery, is unfit for surgery, or does not wish to undergo curative surgery
  • Subject is not a candidate for curative concurrent chemo/radiation therapy or does not wish to undergo curative chemo/radiation therapy
  • The tumor is ≤ 2 cm in size and clearly observable in computerized tomography (CT) with contrast
  • The tumor is accessible for unrestricted illumination of iPDT
  • Subject is willing to remain in a controlled light exposure environment for at least 30 days and for as long as deemed necessary as per the investigator's clinical judgment
  • Subjects diagnosed with small cell lung cancers are ineligible
  • Subjects with Stage IA but central location defined by the Radiation Therapy Oncology Group protocols as the primary tumor located within 2 cm of the proximal bronchial tree or within 2 cm of a major structure are ineligible
  • Subject with concurrent non-solid malignancy are ineligible
  • Subjects whose tumor invades a major blood vessel are ineligible
  • Subject with a planned surgical procedure within the next 90 days are ineligible
  • Subject with a coexisting ophthalmic disease likely to require slit-lamp examination within the next 90 days are ineligible
  • Female subjects who is breastfeeding or intends to breastfeed during the study are ineligible
  • Subjects with known sensitivity to the CT contrast agent, which would preclude the use of the CT contrast agent are ineligible
  • Subject who participates or intends to participate in another investigational study during the study

Applicable Disease Sites Lung

Therapies Involved Other

Drugs Involved Photofrin (Porfimer)

Status Open

Participating Institutions UW Hospital and Clinics