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Photodynamic Therapy for Airway Blockage Due to Cancer

Phase 1 & 2

Recruiting

Led By Nathaniel Ivanick

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from date of study treatment to the time of first observed disease progression (recist 1.1 criteria) at the treated tumor site or, death due to any cause, assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is looking at using a treatment called interstitial photodynamic therapy after palliative radiotherapy to treat patients with inoperable malignant central airway obstruction. This condition occurs when advanced cancer tumors in

Who is the study for?

This trial is for patients with advanced stage cancer causing blockage in the lung's breathing passages, which may be due to various cancers that have spread to the lungs. Candidates must not be eligible for surgery but can undergo palliative radiotherapy and photodynamic therapy.

What is being tested?

The study is testing interstitial photodynamic therapy after palliative radiotherapy on patients with malignant central airway obstruction. It aims to see if this combination improves tumor response and survival while minimizing severe side effects compared to high dose x-ray radiotherapy alone.

What are the potential side effects?

Potential side effects include those associated with palliative radiation like fatigue, skin reactions, or difficulty swallowing, as well as specific risks from photodynamic therapy such as photosensitivity reactions, where the skin becomes very sensitive to light.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from date of study treatment to the time of first observed disease progression (recist 1.1 criteria) at the treated tumor site or, death due to any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from date of study treatment to the time of first observed disease progression (recist 1.1 criteria) at the treated tumor site or, death due to any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from date of study treatment to the time of first observed disease progression (recist 1.1 criteria) at the treated tumor site or, death due to any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of >= grade 3 adverse events (Phase I)

Overall tumor response (Phase II)

Secondary study objectives

Association between immune markers and tumor response (Phase I and II)

Change in the therapeutic laser light transmission (Phase I and II)

Functional lung capacity (Phase I and II)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase II (I-PDT, EBUS, palliative radiation therapy)Experimental Treatment8 Interventions

Phase II: Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-120 minutes after visudyne for up to 2 treatment sessions at least 12 weeks apart. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial.

Group II: Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)Experimental Treatment9 Interventions

Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-120 minutes after visudyne for up to 2 treatment sessions at least 12 weeks apart. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial.

Group III: Phase I cohort 1 (I-PDT, EBUS)Experimental Treatment7 Interventions

Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-120 minutes after visudyne for up to 3 treatment sessions. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palliative Radiation Therapy

2015

Completed Phase 1

~80

Verteporfin

2007

Completed Phase 4

~150