9 Participants Needed

Photodynamic Therapy for Mesothelioma and Lung Cancer

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Roswell Park Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or radiotherapy within 4 weeks before joining the study.

What data supports the effectiveness of this treatment for mesothelioma and lung cancer?

Photodynamic therapy (PDT) has shown promise in treating lung cancer and mesothelioma. In a study with patients having malignant pleural mesothelioma, those with early-stage disease had a median survival of 21 months after receiving PDT, suggesting it may be more effective in earlier stages. Additionally, new photosensitizers have demonstrated high efficiency in killing mesothelioma cells in laboratory settings.12345

Is photodynamic therapy with porfimer sodium safe for humans?

Photodynamic therapy with porfimer sodium is generally safe, but it can cause some side effects like skin sensitivity to light, which can last for several weeks, and esophageal strictures (narrowing of the esophagus) in some cases. These side effects are not usually severe, but they are important to consider.678910

How is the treatment Porfimer Sodium unique for mesothelioma and lung cancer?

Porfimer Sodium is unique because it is a photosensitizing agent used in photodynamic therapy (PDT), which involves activating the drug with light to kill cancer cells. This treatment selectively targets tumor tissues and causes cell death by producing reactive oxygen species when exposed to specific light wavelengths, offering a different approach compared to traditional chemotherapy or radiation.136810

Research Team

SY

Saikrishna S. Yendamuri

Principal Investigator

Roswell Park Cancer Institute

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.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive porfimer sodium intravenously and undergo intraoperative photodynamic therapy (IO-PDT) via a light dosimetry system

1 week
1 visit (in-person for surgery and PDT)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years
Follow-up at 30 days, within 4 weeks from surgery and PDT, and every 6 months

Treatment Details

Interventions

  • Light Dosimetry
  • Light Dosimetry for Intranoperative Therapy
  • Porfimer Sodium
Trial OverviewThe 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.
Participant Groups
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

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+

Lumeda,Inc.

Collaborator

Trials
1
Recruited
9+

References

Photodynamic therapy of human lung cancer xenografts in mice. [2019]
Intracavitary photodynamic therapy for malignant pleural mesothelioma. [2019]
Water-Soluble Truncated Fatty Acid-Porphyrin Conjugates Provide Photo-Sensitizer Activity for Photodynamic Therapy in Malignant Mesothelioma. [2022]
Experimental photodynamic therapy for malignant pleural mesothelioma with pegylated mTHPC. [2018]
Intraoperative photodynamic therapy of the chest cavity in malignant pleural mesothelioma bearing rats. [2012]
The pharmacokinetics and safety of porfimer after repeated administration 30-45 days apart to patients undergoing photodynamic therapy. [2021]
Patient predictors of esophageal stricture development after photodynamic therapy. [2015]
[Porfimer sodium (Photofrin-II)]. [2006]
Photodynamic therapy in dermatology with porfimer sodium and benzoporphyrin derivative: an update. [2018]
Lack of effect of sex and disease state on the pharmacokinetics of porfimer sodium. [2018]