What side effects are associated with this type of intervention?

Photodynamic therapy (PDT) with Porfimer Sodium, which involves activating a photosensitizer with red laser light, can cause side effects such as photosensitivity reactions, where patients may experience severe sunburns if exposed to sunlight or bright indoor light. Other side effects include local inflammation, swelling, and pain at the treatment site. Common treatments for lung cancer, such as chemotherapy and radiation therapy, can cause side effects like fatigue, nausea, vomiting, hair loss, and increased risk of infections. Targeted therapies and immunotherapies may lead to side effects such as skin rashes, diarrhea, liver problems, and immune-related adverse effects.

What prior FDA approvals exist?

Photodynamic therapy (PDT) for lung cancer involves using a photosensitizer such as Porfimer Sodium, which is activated by red laser light to reduce tumor size. The FDA has approved Porfimer Sodium (brand name Photofrin) for the treatment of non-small cell lung cancer (NSCLC) and esophageal cancer. This treatment works by injecting the photosensitizer into the bloodstream, where it accumulates in cancer cells and is then activated by a specific wavelength of light, leading to the destruction of the targeted cells. PDT with Porfimer Sodium is particularly useful for patients with early-stage lung cancer or those who are not candidates for surgery.

What other types of research exist?

Promising alternatives to Photodynamic Therapy with Porfimer Sodium for lung cancer patients include: 1) Sinoporphyrin Sodium (DVDMS), which has shown improved therapeutic efficacy in preclinical models; 2) Endobronchial Ultrasound Guided Interstitial PDT, which offers a targeted approach; and 3) Emerging vascular endothelial growth factor (VEGF) antagonists, which target angiogenesis pathways. These alternatives provide new avenues for treatment and may offer enhanced outcomes for lung cancer patients.

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Photosensitizer

Photodynamic Therapy for Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Nathaniel Ivanick, MD

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

Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 3

Patients with an established pathologic diagnosis of small cell and/or non-small cell lung cancer or other malignancies causing airway obstruction > 25% requiring bronchoscopic intervention or inoperable malignancies not candidates for curative radiotherapy within the airway

Must not have

Patients with target tumor invading into the lumen of the esophagus, confirmed by esophago-gastro-duodenoscopy (EGD) with endoscopic ultrasound

Patients who are not cleared by the anesthesiologist to undergo an advanced bronchoscopy procedure under general anesthesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a treatment where a special drug is injected and then activated by a laser to shrink tumors in lung cancer patients whose cancer has spread. The goal is to see if this method can safely reduce tumor size.

Who is the study for?

This trial is for adults with lung cancer that's spread to nearby areas, who can undergo bronchoscopy under anesthesia. They must have a certain level of platelets in their blood, be able to use birth control if needed, and not be pregnant. People with recent radiotherapy, allergies to porphyrin, unstable health conditions or those unable to follow the study plan cannot join.

What is being tested?

The trial tests a treatment called interstitial photodynamic therapy (I-PDT) using Porfimer sodium on patients with advanced lung cancer. It involves injecting this drug and activating it with laser light inside the airways to shrink tumors.

What are the potential side effects?

Possible side effects include reactions related to the photosensitizer like skin sensitivity to light. There may also be typical risks associated with bronchoscopy such as bleeding or infection at the site of intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but can't do heavy physical work.

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I have lung cancer or another cancer that blocks my airways by more than 25% and cannot be removed or cured by radiation.

Exclusion Criteria

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

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My cancer has spread into the esophagus, confirmed by a special camera test.

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I am not cleared for advanced bronchoscopy under general anesthesia.

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

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I have been diagnosed with porphyria.

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I am currently pregnant or breastfeeding.

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I have an eye condition that may need a detailed eye exam soon after my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tumor response rate - Phase II study

Secondary study objectives

Progression-free survival (PFS) assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

Other study objectives

Immune biomarkers measured with Spearman rank correlation

Porfimer sodium retention in the target tumor tissue

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (porfimer sodium, EBUS, and photodynamic therapy)Experimental Treatment2 Interventions

Patients receive porfimer sodium IV over 20 minutes 2-4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over 30-45 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Porfimer Sodium

2017

Completed Phase 2

~60

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Photodynamic therapy (PDT) with Porfimer Sodium involves injecting a photosensitizer into the bloodstream, which accumulates in tumor cells. When exposed to red laser light, the photosensitizer produces reactive oxygen species that destroy the cancer cells while sparing healthy tissue. This targeted approach is crucial for lung cancer patients as it minimizes collateral damage and focuses on reducing tumor size. Other common treatments include chemotherapy, which uses cytotoxic drugs to kill rapidly dividing cells, and immunotherapy, which boosts the immune system's ability to fight cancer. These treatments are essential for managing lung cancer, improving survival rates, and enhancing patients' quality of life.