Photodynamic Therapy Using HPPH in Treating Patients With Advanced Non-Small Cell Lung Cancer That Blocks the Air Passages

Phase 2

Terminated

• Conditions: Lung Cancer
• Interventions: Drug: HPPH; Procedure: endoscopic procedure

• Registration Number: NCT00528775
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

RATIONALE: 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, tumor cells are killed. This may be an effective treatment for advanced non-small cell lung cancer that blocks the air passages.

PURPOSE: This phase II trial is studying how well photodynamic therapy using HPPH works in treating patients with advanced non-small cell lung cancer that blocks the air passages.

Detailed Description

OBJECTIVES:

Primary

* To determine the efficacy of photodynamic therapy (PDT) using HPPH in patients with advanced obstructing endobronchial non-small cell lung cancer.

Secondary

* To determine palliation of symptoms in patients treated with this regimen.

* To determine the amount of HPPH taken up by the obstructing endobronchial tumors in these patients.

* To determine the extent of STAT3 cross-links, which are molecular markers of immediate PDT reaction, in the obstructing tumors of these patients before and after PDT treatment.

* To determine inflammation and apoptosis in the obstructing bronchial tumors of these patients before and after PDT treatment.

OUTLINE: Patients receive HPPH IV over 1 hour on day 1. On day 3, patients undergo photodynamic therapy (PDT) comprising laser light delivered by flexible, fiberoptic fibers 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.

Patients may undergo tumor biopsies periodically during study for optional biomarker/correlative studies. Tumor tissue samples are analyzed for STAT3 cross-links by western blotting; apoptosis and inflammation biomarkers by immunohistochemistry, TUNEL, and other immunological laboratory methods; and tumor concentrations of HPPH by fluorescence emission spectroscopy.

After completion of study treatment, patients are followed at 4-6 weeks and then periodically thereafter.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-10
• Study First Submitted QC: 2007-09-10
• Study First Posted: 2007-09-12
• Primary Completion: 2009-11
• Study Completion: 2014-03
• Status Verified: 2014-05
• Results First Submitted: 2014-05-09
• Results First Submitted QC: 2014-05-09
• Last Update Submitted: 2014-05-09
• Results First Posted: 2014-06-10
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HPPH	endoscopic procedure	Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH	HPPH	Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.

Primary Outcome Measures

Name	Time	Method
Tumor Response	6 months

Secondary Outcome Measures

Name	Time	Method
STAT3 Cross-links as Assessed by Western Blotting	2 months
Inflammation and Apoptosis as Assessed by Immunohistochemistry	2 months
Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale	2 months
Photosensitizer (HPPH) Concentration in Tumor	2 months

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States