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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT03727061
Phase
PHASE1
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 10, 2019
Status verified
Jan 2025
Primary completion
Oct 22, 2024
Completion
Oct 22, 2024

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A(porfimer sodium, I-PDT
    Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.

Primary Outcome Measure

Frequency of Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [ Time Frame: Up to 30 days ]

Locations (1)

FacilityCityStateZIP
Roswell Park Cancer InstituteBuffaloNew York14263-0001

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By research site
Roswell Park Cancer Institute· Buffalo, NY

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