A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable, Primary or Recurrent Head and Neck Cancer
- Determine the maximum tolerated dose of photodynamic therapy comprising HPPH in
patients undergoing surgery for primary or recurrent squamous cell cancer of the head
- Determine the efficacy of this regimen, in terms of tumor recurrence rate, in these
- Determine HPPH uptake and distribution in these patients.
- Observe for wound complications in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of laser light.
Patients receive HPPH IV over 1 hour on day 1. Patients undergo surgery followed by laser
light exposure to the entire tumor bed on day 2.
Cohorts of 3-6 patients receive escalating doses of laser light until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at 1 month, every 3 months for 2
years, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of photodynamic therapy
Within 24 hours of treatment
Nestor R. Rigual, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|