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Photosensitizer
Photodynamic Therapy for Mesothelioma and Lung Cancer
Phase 1
Waitlist Available
Led By Saikrishna Yendamuri
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) scale of 0-2.
Histologically confirmed malignant mesothelioma, non-small cell lung cancer (NSCLC) or other malignancies with pleural disease without distant disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of treatment (surgery + pdt) until death from any cause, assessed up to 3 years
Awards & highlights
Study Summary
This trial is testing a new way to measure the amount of light given during a cancer treatment called photodynamic therapy. They want to see if this new measure is more accurate than the current method and if it can help doctors decide if the treatment should be stopped or continued.
Who is the study for?
This trial is for adults with malignant mesothelioma, non-small cell lung cancer, or pleural disease who are undergoing surgery. They must be in fair to good physical condition (ECOG 0-2), agree to use birth control if applicable, and not have distant spread of the disease. People with low white blood cells or platelets, liver issues, uncontrolled illnesses like heart failure or infections, brain metastases, recent other treatments or investigational drugs can't join.Check my eligibility
What is being tested?
The study tests a light dosimetry system during photodynamic therapy using porfimer sodium on patients having surgery for certain cancers affecting the chest lining. It aims to determine how well this method works by measuring laser light used to activate the drug that may kill tumor cells.See study design
What are the potential side effects?
Possible side effects include reactions related to porfimer sodium which can cause sensitivity to light leading to skin damage when exposed to sunlight or bright indoor lights. Other risks involve typical surgical complications and potential harm from activated drugs targeting tumor cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
Select...
My cancer is confirmed to be in the lining of my chest but hasn't spread far.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of treatment (surgery + pdt) until death from any cause, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of treatment (surgery + pdt) until death from any cause, assessed up to 3 years
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 Common Terminology Criteria for Adverse Events version 5.0
Secondary outcome measures
Anti tumor response
Overall survival (OS)
Progression-free survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (porfimer sodium, IO-PDT)Experimental Treatment3 Interventions
Participants receive porfimer sodium IV over 3-5 minutes and receive IO-PDT via a light dosimetry system 24-48 hours later.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Photodynamic Therapy
2014
Completed Phase 4
~460
Porfimer Sodium
2017
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Lumeda,Inc.UNKNOWN
Roswell Park Cancer InstituteLead Sponsor
405 Previous Clinical Trials
31,298 Total Patients Enrolled
2 Trials studying Mesothelioma
32 Patients Enrolled for Mesothelioma
Saikrishna YendamuriPrincipal InvestigatorRoswell Park Cancer Institute
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have brain metastases.Your blood test shows that your creatinine level is higher than 2 mg/dL.Your SGOT or SGPT levels are more than three times the normal limit.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.I am able to get out of my bed or chair and move around.Your platelet count is less than 100,000.Your alkaline phosphatase levels are more than three times the normal limit.Your white blood cell count is less than 4,000.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My cancer is confirmed to be in the lining of my chest but hasn't spread far.Your bilirubin level in the blood is higher than 2 mg/dL.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (porfimer sodium, IO-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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