Photodynamic Therapy in Treating Patients With Lung Cancer
Adenocarcinoma of the Lung
Large Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Squamous Cell Lung Cancer
Stage 0 Non-small Cell Lung Cancer
Drug: photodynamic therapy
Procedure: therapeutic bronchoscopy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Light Dose for Photodynamic Therapy(PDT) Using 2-[ 1-hexyloxyethel]-2-devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-small Cell Carcinoma in Situ or Non-small Cell Microinvasive Carcinoma. A Dose Ranging Study|
- MTID [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]Defined as the dose at which =< 1 out of 6 patients experiences dose-limiting toxicity.
- Systemic toxicity according to NCI Common Toxicity Criteria version 2 [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
- PDT-related normal tissue toxicity [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]Assessed by a scale with grades 0-3 being acceptable, grade 4 being unacceptable, and grade 5 being stopping study.
- Objective tumor response [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (PDT using HPPH)
Patients receive HPPH IV over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.
Other Name: PhotochlorDrug: photodynamic therapy
Undergo photodynamic therapy with HPPH
Other Names:Procedure: therapeutic bronchoscopy
Undergo therapeutic bronchoscopy for endoscopic debridement
I. To determine maximally tolerated light dose (MTID). Identify systemic and normal tissue toxicity using 2-[hexyloxyethyl)-2-devinyl pyropheophorbide-a (HPPH) for photodynamic therapy in patients with bronchogenic carcinoma-in-situ (CIS) or microinvasive carcinoma.
I. To study tumor response in patients with bronchogenic carcinoma-in-situ (CIS) or bronchogenic microinvasive carcinoma.
OUTLINE: This is a dose-escalation study.
Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.
After completion of study treatment, patients are followed up at 4-6 weeks, 6 months, and then periodically for at least 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668823
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Samjot Dhillon||Roswell Park Cancer Institute|