A Phase I Study of Light Dose for Photodynamic Therapy(PDT) Using 2-[ 1-hexyloxyethel]-2-devinyl Pyropheophorbide-a (HPPH) for treatment of Bronchogenic Carcinoma in situ or bronchogenic Microinvasive Carcinoma. A Dose Ran...
Title A Phase I Study of Light Dose for Photodynamic Therapy(PDT) Using 2-[ 1-hexyloxyethel]-2-devinyl Pyropheophorbide-a (HPPH) for treatment of Bronchogenic Carcinoma in situ or bronchogenic Microinvasive Carcinoma. A Dose Ranging Study
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Principal Investigator Samjot Dhillon, MD
Study Number 05903
Phase1
Summary Patients with carcinoma in situ/early stage cancer are injected with HPPH and two days later are bronchscopically treated with light from a laser.
Eligibility
- Patients with biopsy confirmed carcinoma-in-situ (CIS) or microinvasive lung cancer.
- Patients may have received prior therapy for lung cancer of any type, e.g. chemotherapy, radiation therapy.
- Patients must have no contraindications for bronchoscopy.
- Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous/debris formation at the site of treatment.
- Patients must sign an informed consent according to the FDA guidelines acceptable to the RPCI IRB.
Exclusion:
- Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
- Patients with impaired hepatic or renal function.
- MI or unstable angina in the previous 6 months.
