Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Roswell Park Cancer Institute, Buffalo, NYLung Cancer+6 MoreUltrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Lung Cancer
  • Stage III Lung Cancer
  • Stage IIIA Lung Cancer
  • Stage IIIB Lung Cancer
  • Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Up to 24 weeks

Week 24
Progression-free survival (PFS) assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Up to 24 weeks
Immune biomarkers measured with Spearman rank correlation
Porfimer sodium retention in the target tumor tissue
Up to 4 weeks
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
up to 24 weeks
Tumor response rate - Phase II study

Trial Safety

Trial Design

1 Treatment Group

Treatment (porfimer sodium, EBUS, and photodynamic therapy)
1 of 1

Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy · No Placebo Group · Phase 1 & 2

Treatment (porfimer sodium, EBUS, and photodynamic therapy)Experimental Group · 2 Interventions: Porfimer Sodium, Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy · Intervention Types: Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Porfimer sodium
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 weeks

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
382 Previous Clinical Trials
29,813 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,167 Previous Clinical Trials
41,168,461 Total Patients Enrolled
Nathaniel Ivanick, MDPrincipal InvestigatorRoswell Park Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.