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
- 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
Primary Purpose: Treatment
Gregory M. Loewen, DO, FCCP
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|