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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My head or neck cancer has not improved with standard treatments and cannot be cured with usual methods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
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
~4750
Porfimer Sodium
2017
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
405 Previous Clinical Trials
31,320 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,965,118 Total Patients Enrolled
Kimberly Wooten, MDPrincipal InvestigatorRoswell Park Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor cannot be treated with I-PDT due to its location or size.I can take care of myself and am up and about more than half of my waking hours.My cancer has spread to a major blood vessel.I am currently pregnant or breastfeeding.You have a condition called porphyria or are allergic to substances called porphyrins or similar compounds.My tumor can be reached for light-based treatment as decided by my doctor.My tumor cannot be measured using CT or MRI scans.I am eligible for treatments like chemotherapy, targeted therapy, immunotherapy, or other approved methods for my condition.I do not have brain metastases.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My kidney function is not severely impaired.My doctor thinks I shouldn't receive porfimer sodium.I have not had radiotherapy in the last 30 days in the area that needs treatment.My head or neck cancer has not improved with standard treatments and cannot be cured with usual methods.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A(porfimer sodium, I-PDT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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