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Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy) for Cancer

Phase 1 & 2

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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

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

Primary outcome measures

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

Overall tumor response (Phase II)

Secondary outcome measures

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase II (I-PDT, EBUS, palliative radiation therapy)Experimental Treatment7 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 60-90 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 Treatment8 Interventions

Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-90 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 60-90 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

Verteporfin

2007

Completed Phase 4

~150

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Palliative Radiation Therapy

2015

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,819 Total Patients Enrolled

Nathaniel IvanickPrincipal InvestigatorRoswell Park Cancer Institute

Frequently Asked Questions

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

Are new participants being enrolled in this study at present?

"As per clinicaltrials.gov, recruitment for this particular trial is currently closed. Originally listed on April 1st, 2024 and last updated on March 5th, 2024. Despite the closure of this trial, there are currently 131 alternative studies actively seeking participants."

Answered by AI

What is the primary objective of conducting this clinical trial?

"The primary objective of this research, to be assessed within 30 days post interstitial photodynamic therapy (I-PDT), is the overall tumor response in Phase II. Secondary endpoints include changes in therapeutic laser light transmission across both Phase I and II, which will be quantified using our light dosimetry system. Furthermore, investigating the correlation between immune markers and tumor response during Phases I and II involves analyzing fresh blood samples collected pre- and post-I-PDT through flow cytometry. Lastly, evaluating the overall tumor response specifically for Phase I will rely on achieving either a complete or partial response according to RECIST v1.1 criteria"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction

2024. "Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06306638.

All > Photodynamic Therapy