Clinical Trial: Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent Head and Neck Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable, Primary or Recurrent Head and Neck Cancer

Brief Summary: This phase I trial studies 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. Photodynamic therapy (PDT) 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Identifying the maximum tolerated dose (MTD) of PDT among 4 investigated light dose levels (30, 50, 60 and 75) in combination with surgery in patients with recurrent or primary head and neck cancers.

SECONDARY OBJECTIVES:

I. To make initial observations of efficacy (i.e., tumor recurrence rate) of adjuvant PDT in these patients.

II. To determine the HPPH uptake and distribution (when feasible) in recurrent resected specimens.

III. Observe for wound complications.

OUTLINE: This is a dose-escalation study of laser light.

Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2.

After the completion of study treatment, patients are followed up at 1 and 3 months and then periodically thereafter at the discretion of the treating physician.


Sponsor: Roswell Park Cancer Institute

Current Primary Outcome: Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity [ Time Frame: 30 days ]

Original Primary Outcome: Maximum tolerated dose of photodynamic therapy

Current Secondary Outcome:

  • Time to tumor progression or recurrence [ Time Frame: From baseline until objective tumor progression, assessed up to 5 years ]
  • Uptake and distribution of HPPH in resected tumor tissue [ Time Frame: Day 2 ]


Original Secondary Outcome:

  • Tumor progression or recurrence
  • HPPH uptake and distribution


Information By: Roswell Park Cancer Institute

Dates:
Date Received: May 3, 2007
Date Started: October 19, 2006
Date Completion: October 1, 2018
Last Updated: March 28, 2017
Last Verified: March 2017