NCT00025571

Photodynamic Therapy With HPPH in Treating Patients With Non-Small Cell Lung Cancer

A Phase I Study of Photodynamic Therapy (PDT) Using 2-(1-hexyloxyethyl)-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Early Stage Lung Cancer - A Dose Ranging Study

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

Summary

RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have non-small cell lung cancer.

Detailed description

OBJECTIVES: * Determine the systemic and normal tissue toxicity of photodynamic therapy with HPPH in patients with early stage or centrally obstructing non-small cell lung cancer. * Determine, preliminarily, the efficacy of this regimen in these patients. OUTLINE: This is a dose-escalation study of HPPH. Patients receive HPPH IV over 1 hour on day 1. Patients undergo laser light therapy via bronchoscopy on day 3. Cohorts of 3-6 patients receive escalating doses of HPPH until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for at least 6 months. PROJECTED ACCRUAL: Approximately 15-17 patients will be accrued for this study within 2 years.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	HPPH

Timeline

• Start date: 2001-06-01
• Primary completion: 2002-10-01
• Completion: 2004-10-01
• First posted: 2003-06-25
• Last updated: 2011-03-07

Locations

1 site across 1 country: United States