Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent Head and Neck Cancer
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. Giving photodynamic therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients who are undergoing surgery for primary or recurrent head and neck cancer.
Head and Neck Cancer
Procedure: therapeutic conventional surgery
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable, Primary or Recurrent Head and Neck Cancer|
- Maximum tolerated dose of photodynamic therapy [ Time Frame: Within 24 hours of treatment ] [ Designated as safety issue: Yes ]
- Tumor progression or recurrence [ Time Frame: At 1 month and 3 months ] [ Designated as safety issue: No ]
- HPPH uptake and distribution [ Time Frame: At 1 and 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||July 2014|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Patients receive HPPH IV over 1 hour on day 1.
Given IVProcedure: therapeutic conventional surgery
- Determine the maximum tolerated dose of photodynamic therapy comprising HPPH in patients undergoing surgery for primary or recurrent squamous cell cancer of the head and neck.
- Determine the efficacy of this regimen, in terms of tumor recurrence rate, in these patients.
- 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.
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Nestor R. Rigual, MD||Roswell Park Cancer Institute|