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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
Eligibility checklist before registration requires review of case by study surgeon or interventional pulmonologists to approve anatomic feasibility of an airway intervention
Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
No Placebo-Only Group

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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A specialist has confirmed that my airway can be treated with a procedure.
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I can take care of myself but can't do heavy physical work.
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I am willing to undergo a specific low-dose radiation treatment as advised by my radiation oncologist.
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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 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

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

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
394 Previous Clinical Trials
30,478 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
~38 spots leftby Feb 2030