Trial Summary
What is the purpose of this trial?This phase I trial studies the side effects and how well light dosimetry system works during photodynamic therapy with porfimer sodium in treating participants with malignant mesothelioma , non-small cell lung cancer or any other malignancy with pleural disease undergoing surgery. Light dosimetry measures the amount of laser light given during photodynamic therapy. Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active when it is exposed to light. The activated drug may kill tumor cells. Using light dosimetry for intraoperative photodynamic therapy may help doctors estimate how much light is delivered during photodynamic therapy and decide if the treatment should be stopped or continued.
Eligibility Criteria
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.Inclusion Criteria
Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 6 months after surgery.
I am able to get out of my bed or chair and move around.
The subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure.
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Exclusion 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.
+10 more
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Roswell Park Cancer InstituteBuffalo, NY
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Who Is Running the Clinical Trial?
Roswell Park Cancer InstituteLead Sponsor
Lumeda,Inc.Collaborator