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NCT03678350CompletedPhase 1

Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery

Light Dosimetry for Intraoperative Photodynamic Therapy (IO-PDT) With Porfimer Sodium (Photofrin) in Patients With Malignant Mesothelioma or Non-Small Cell Lung Cancer (NSCLC), or Other Malignancies With Pleural Disease - Phase I Study

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
9 (actual)
First submitted
30 Aug 2018
Start date
17 Sept 2021
Primary completion date
13 Nov 2023
Lead sponsor
Roswell Park Cancer Institute
NCT number
NCT03678350

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 9
  • From 17 Sept 2021 to the primary completion date, 13 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Received an investigational agent within 30 days prior to enrollment.

Other illness

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Lab values

  • White blood cell (WBC) \< 4,000.
  • Platelet count \< 100,000.
  • Total serum bilirubin \> 2 mg/dL.
  • Serum creatinine \> 2 mg/dL.
  • Alkaline phosphatase \> 3 times the upper normal limit.
  • Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) \> 3 times the upper normal limit.
  • Any condition which in the investigator?s opinion deems the subject an unsuitable candidate to receive porfimer sodium.

Other

  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Pregnant or nursing female subjects.
  • Unwilling or unable to follow protocol requirements.

Who the study is looking for

  • Histologically confirmed malignant mesothelioma , non-small cell lung cancer (NSCLC) or other malignancies with pleural disease without distant disease.
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) scale of 0-2.
  • 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. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Roswell Park Cancer Institute
Coordinator of this site? Confirm its status
BuffaloUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.