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.

Must not have

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.

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.

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

No Placebo-Only Group

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.

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.

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 below

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I am able to get out of my bed or chair and move around.

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My cancer is confirmed to be in the lining of my chest but hasn't spread far.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have brain metastases.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of treatment (surgery + pdt) until death from any cause, assessed up to 3 years for reporting.