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Photodynamic Therapy for Head and Neck Cancer

Phase 1
Recruiting
Led By Kimberly Wooten, MD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
Patients with locally advanced or recurrent head and neck cancer who failed to respond to standard therapy and are not amenable to standard curative treatment
Must not have
Location and extension of the tumor precludes a potentially effective I-PDT
Tumor invading a major blood vessel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that uses light-sensitive drugs and laser light to kill cancer cells.

Who is the study for?
This trial is for adults with advanced or recurrent head and neck cancer who haven't responded to standard treatments. They must be able to undergo chemotherapy, have a life expectancy of at least 6 months, and agree to use contraception if applicable. The tumor should be accessible for treatment and measurable by scans.
What is being tested?
The study is testing the effectiveness of porfimer sodium interstitial photodynamic therapy (PDT), which uses light-activated drugs, alone or with standard chemotherapy in treating head and neck cancer that's spread or returned.
What are the potential side effects?
Potential side effects include reactions related to the light-sensitive drug such as skin sensitivity to light, local tissue damage where PDT is applied, typical chemotherapy-related issues like nausea, fatigue, hair loss, increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My head or neck cancer has not improved with standard treatments and cannot be cured with usual methods.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My tumor cannot be treated with I-PDT due to its location or size.
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My cancer has spread to a major blood vessel.
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I am currently pregnant or breastfeeding.
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My tumor cannot be measured using CT or MRI scans.
Select...
I do not have brain metastases.
Select...
I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
Select...
My kidney function is not severely impaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm A(porfimer sodium, I-PDTExperimental Treatment4 Interventions
Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220
Porfimer Sodium
2017
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
412 Previous Clinical Trials
32,768 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,453 Total Patients Enrolled
Kimberly Wooten, MDPrincipal InvestigatorRoswell Park Cancer Institute

Media Library

Interstitial Illumination Photodynamic Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03727061 — Phase 1
Head and Neck Cancers Research Study Groups: Arm A(porfimer sodium, I-PDT
Head and Neck Cancers Clinical Trial 2023: Interstitial Illumination Photodynamic Therapy Highlights & Side Effects. Trial Name: NCT03727061 — Phase 1
Interstitial Illumination Photodynamic Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03727061 — Phase 1
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