Symptoms and General Pathology

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Head and Neck Neoplasms

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Immune Checkpoint Inhibitors

Photosensitizing Agents

Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.

Porfimer Sodium

Interstitial Illumination Photodynamic Therapy

Quality of Life Assessment

Kimberly Wooten, MD

ASK RPCI

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.

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.

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

The frequency of toxicities will be tabulated by grade across all dose levels and cycles. All subjects who receive any study treatment will be considered evaluable for toxicity. Sequential boundaries will be used to monitor the serious adverse event (SAE) rate.

National Cancer Institute (NCI)

Roswell Park Cancer Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer	NCT03727061	Recurrent Head ... Locally Advance...	Nivolumab Porfimer Sodium Interstitial Il... Quality of Life...	18 Years -	Roswell Park Cancer Institute
Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer	NCT03727061	Recurrent Head ... Locally Advance...	Nivolumab Porfimer Sodium Interstitial Il... Quality of Life...	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for interstitial illumination photodynamic therapy