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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 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-03-11

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Kimberly Wooten, MD · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-10
Primary Completion
2024-10-22
Completion
2024-10-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03727061 on ClinicalTrials.gov