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Photodynamic Therapy for Head and Neck Cancer

Phase 2
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
Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 10-12 weeks
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 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 tumor can be reached for light-based treatment as decided by my doctor.
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I am eligible for treatments like chemotherapy, targeted therapy, immunotherapy, or other approved methods for my condition.
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My head or neck cancer has not improved with standard treatments and cannot be cured with usual methods.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 10-12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 10-12 weeks for reporting.

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 (Phase I)
Objective target tumor response rates (Phase II)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B(porfimer sodium, I-PDT, SoC chemotherapy)Experimental Treatment9 Interventions
Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later. Patients also receive SoC chemotherapy (cisplatin, carboplatin, fluorouracil, cetuximab, nivolumab, pembrolizumab) at the oncologist's discretion at either 7 days, 14 days, or 28 days later.
Group II: Arm A (standard of care chemotherapy at doctor's discretion)Active Control7 Interventions
Patients receive SoC chemotherapy (cisplatin, carboplatin, fluorouracil, cetuximab, nivolumab, pembrolizumab) at the oncologist's discretion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
Fluorouracil
2014
Completed Phase 3
~11540
Nivolumab
2014
Completed Phase 3
~4750
Porfimer Sodium
2017
Completed Phase 2
~60
Pembrolizumab
2017
Completed Phase 2
~2010
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
400 Previous Clinical Trials
30,717 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,313 Total Patients Enrolled
Kimberly Wooten, MDPrincipal InvestigatorRoswell Park Cancer Institute

Media Library

Interstitial Illumination Photodynamic Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03727061 — Phase 2
Head and Neck Cancers Research Study Groups: Arm A (standard of care chemotherapy at doctor's discretion), Arm B(porfimer sodium, I-PDT, SoC chemotherapy)
Head and Neck Cancers Clinical Trial 2023: Interstitial Illumination Photodynamic Therapy Highlights & Side Effects. Trial Name: NCT03727061 — Phase 2
Interstitial Illumination Photodynamic Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03727061 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned the use of Pembrolizumab?

"Pembrolizumab has been granted a safety rating of 2 due to limited data confirming its efficacy, which is expected when the drug is in Phase 2 clinical trials."

Answered by AI

Is this research endeavor still recruiting participants?

"According to clinicaltrials.gov, this experiment is actively recruiting patients as of now. It was introduced on July 10th 2019 and most recently updated September 27th 2022."

Answered by AI

How many participants can this clinical trial accommodate?

"Affirmative. According to clinicaltrials.gov, the trial was initially listed on July 10th 2019 and has recently been updated on September 27th 2022. Eighty-two individuals are needed for this investigation at one study site."

Answered by AI

What maladies does Pembrolizumab typically target?

"Pembrolizumab is regularly deployed to treat unresectable melanoma, and can be used as a safeguard against microsatellite instability high, squamous cell carcinoma, or the possibly of recurrence."

Answered by AI
~10 spots leftby Dec 2024