NCT01668823

Photodynamic Therapy in Treating Patients With Lung Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with lung cancer. Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	HPPH	Given IV
DRUG	photodynamic therapy	Undergo photodynamic therapy with HPPH
PROCEDURE	therapeutic bronchoscopy	Undergo therapeutic bronchoscopy for endoscopic debridement

Timeline

• Start date: 2004-02-01
• Primary completion: 2013-06-01
• Completion: 2014-06-01
• First posted: 2012-08-20
• Last updated: 2014-07-31

Locations

1 site across 1 country: United States