Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed.
PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with stage 0 non-small cell lung cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study Light Dose for Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-Small Cell Carcinoma in Situ or Non-Small Cell Microinvasive Bronchogenic Carcinoma: A Dose Ranging Study|
- Toxicity as measured by NCI CTC v2.0 [ Time Frame: Daily while in-house, weekly after discharge, at 4-6 weeks and at 6 months ] [ Designated as safety issue: Yes ]
- Tumor response [ Time Frame: At 4-6 weeks and 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Study Completion Date:||April 2014|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: PDT using HPPH
Patients receive HPPH IV over 1 hour on day 1. Patients then receive photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.
- To determine the maximally tolerated light dose (MTID) in patients with bronchogenic carcinoma in situ (CIS) or bronchogenic microinvasive carcinoma.
- To identify the systemic and normal tissue toxicity resulting from photodynamic therapy using HPPH in these patients.
- To study tumor response in these patients.
OUTLINE: Patients receive HPPH IV over 1 hour on day 1. Approximately 2 days later, patients undergo photodynamic therapy (PDT) using laser light passed through the biopsy channel of an endoscope. Patients undergo endoscopic debridement on day 5. If viable tumor is found outside of the initial treatment area, patients may receive another dose of laser light without additional HPPH at that time.
After completion of study treatment, patients are followed at 4-6 weeks, 6 months, and periodically thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526461
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Samjot Dhillon, MD||Roswell Park Cancer Institute|