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Photosensitizer

Photodynamic Therapy for Lung Cancer

Phase 1 & 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Awards & highlights

Study Summary

This trial is testing a new cancer treatment that uses light to kill cancer cells.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events that are >= grade 4 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0

Tumor response rate - Phase II study

Secondary outcome measures

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

Other outcome measures

Immune biomarkers measured with Spearman rank correlation

Porfimer sodium retention in the target tumor tissue

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pinnacle Biologics Inc.Industry Sponsor

7 Previous Clinical Trials

1,018 Total Patients Enrolled

Simphotek Inc.UNKNOWN

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,793 Total Patients Enrolled

Media Library

Porfimer Sodium (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT03735095 — Phase 1 & 2

Lung Cancer Research Study Groups: Treatment (porfimer sodium, EBUS, and photodynamic therapy)

Lung Cancer Clinical Trial 2023: Porfimer Sodium Highlights & Side Effects. Trial Name: NCT03735095 — Phase 1 & 2

Porfimer Sodium (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03735095 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What has been observed in prior research on Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy?

"Currently, there are 5 ongoing clinical trials exploring Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy. None of these studies have yet reached Phase 3; however, they can be found in 6 different locations around Buffalo, New york."

Answered by AI

Are there any current opportunities to sign up for this research endeavor?

"According to the clinicaltrials.gov listing, this research initiative is actively looking for volunteers; it was first posted in February 12th 2020 with a subsequent update occurring on May 31st 2022."

Answered by AI

What is the aggregate number of participants enrolled in this research project?

"Affirmative. Clinicaltrials.gov conveys that this medical research is seeking participants, which was originally announced on 2/12/2020 and most recently revised on 5/31/2022. This study requires 36 patients to be enrolled from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer

2020. "Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03735095.

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