NCT03727061

Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer

A Phase 1 Trial: Porfimer Sodium Mediated Interstitial Photodynamic for the Treatment of Patients With Locally Advanced or Recurrent Head and Neck Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects of interstitial photodynamic therapy (I-PDT) in treating patients with head and neck cancer that has spread to other parts of the body or that has come back. Interstitial photodynamic therapy uses a light-sensitive drug called porfimer sodium. This drug is activated by laser light delivered through special fibers into the tumor. In this study the doctors will evaluate the safety of I-PDT and determine the potentially effective light setting in this treatment.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety of porfimer sodium (Photofrin) mediated interstitial photodynamic therapy (I-PDT) in patients with locally advanced or recurrent head and neck cancer (HNC) . * To determine the recommended light irradiance dose for a future Phase 2 trial of Photofrin® mediated I-PDT in patients with locally advanced or recurrent HNC EXPLORATORY OBJECTIVES: I . To access the objective tumor response rate OUTLINE: This is a phase I study . Patients receive porfimer sodium intravenously (IV) over 3-5 minutes and undergo I-PDT approximately 48 hours later. After completion of study treatment, patients are followed up every 1-3 months for the first year, 2-6 months for 2nd year, and annually up to 5 years.

Conditions

• Recurrent Head and Neck Carcinoma
• Locally Advanced Head and Neck Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Immunotherapy - Standard of care
DRUG	Porfimer Sodium	Given IV
PROCEDURE	Interstitial Illumination Photodynamic Therapy	Undergo I-PDT
OTHER	Quality of Life Assessment	Ancillary Studies

Timeline

• Start date: 2019-07-10
• Primary completion: 2024-10-22
• Completion: 2024-10-22
• First posted: 2018-11-01
• Last updated: 2025-03-11
• Results posted: 2025-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study