Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-01-03 @ 8:21 PM
Study NCT ID:
NCT03727061
Status:
TERMINATED
Last Update Posted:
2025-03-11
First Post:
2018-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
A Phase 1 Trial: Porfimer Sodium Mediated Interstitial Photodynamic for the Treatment of Patients With Locally Advanced or Recurrent Head and Neck Cancer
Status:
TERMINATED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects of interstitial photodynamic therapy (I-PDT) in treating patients with head and neck cancer that has spread to other parts of the body or that has come back. Interstitial photodynamic therapy uses a light-sensitive drug called porfimer sodium. This drug is activated by laser light delivered through special fibers into the tumor.
In this study the doctors will evaluate the safety of I-PDT and determine the potentially effective light setting in this treatment.
In this study the doctors will evaluate the safety of I-PDT and determine the potentially effective light setting in this treatment.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the safety of porfimer sodium (Photofrin) mediated interstitial photodynamic therapy (I-PDT) in patients with locally advanced or recurrent head and neck cancer (HNC) .
* To determine the recommended light irradiance dose for a future Phase 2 trial of Photofrin® mediated I-PDT in patients with locally advanced or recurrent HNC
EXPLORATORY OBJECTIVES:
I . To access the objective tumor response rate
OUTLINE: This is a phase I study .
Patients receive porfimer sodium intravenously (IV) over 3-5 minutes and undergo I-PDT approximately 48 hours later.
After completion of study treatment, patients are followed up every 1-3 months for the first year, 2-6 months for 2nd year, and annually up to 5 years.
I. To determine the safety of porfimer sodium (Photofrin) mediated interstitial photodynamic therapy (I-PDT) in patients with locally advanced or recurrent head and neck cancer (HNC) .
* To determine the recommended light irradiance dose for a future Phase 2 trial of Photofrin® mediated I-PDT in patients with locally advanced or recurrent HNC
EXPLORATORY OBJECTIVES:
I . To access the objective tumor response rate
OUTLINE: This is a phase I study .
Patients receive porfimer sodium intravenously (IV) over 3-5 minutes and undergo I-PDT approximately 48 hours later.
After completion of study treatment, patients are followed up every 1-3 months for the first year, 2-6 months for 2nd year, and annually up to 5 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA193610 | NIH | None | https://reporter.nih.gov/quic… | View |
| P01CA055791 | NIH | None | https://reporter.nih.gov/quic… | View |