Safety of PDT-Photofrin® Prior to Lung Surgery
Condition: Lung Cancer; Lung Cancer Metastatic
MeSH terms: Lung Neoplasms
Intervention: Porfimer Sodium; Fiber optic
Intervention description: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.; After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Intervention MeSH terms: Dihematoporphyrin Ether; Trioxsalen
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: lung cancer; lung carcinoma; lung metastases

Summary:

      This research study is being conducted to assess the safety of PDT in subjects with
      peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will
      involve up to 10 sites in USA. Participation will last 4 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18-79

          -  Diagnosed with primary or metastatic tumor < 5 cm located in peripheral lung that can
             be completely resectable

          -  Candidate for surgical resection

          -  Candidate for bronchoscopy

          -  Tumor is accessible for unrestricted illumination of PDT

          -  Subject is deemed likely to survive for at least 3 months

          -  Non-menopausal/non-sterile female subject of childbearing potential has negative B-HCG
             (Human chorionic gonadotropin) at time of study entry

          -  Non-menopausal/non-sterile female subject of childbearing potential uses medically
             acceptable form of birth control

          -  Subject is able and willing to provide written informed consent to participate in the
             study, which must comply with ICH (International Council for Harmonisation) guidelines
             & local requirements

        Exclusion Criteria:

          -  Diagnosis of small cell lung cancer or carcinoid tumors

          -  Primary or metastatic lung tumor located in central lung or near vertebral body

          -  Tumor invades a major blood vessel

          -  Presence of concurrent non-solid malignancy

          -  Tumor previously treated with radiation therapy

          -  Chemotherapy in the last four weeks

          -  Tumor treated with PDT within the last 3 months

          -  Abnormal blood results

          -  Subject with porphyria or hypersensitivity to Photofrin

          -  Coexisting ophthalmic disease likely to required slit-lamp exam within next 90 days

          -  Acute or chronic medical or psychological illness as judged clinical significant to PI
             to preclude bronchoscopy procedures

          -  female who is breast-feeding or intends to breast-feed during study

          -  subject who participated in another study within last 30 days or intends to
             participate in another study during this study