Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-01-05 @ 6:04 PM
Study NCT ID:
NCT02068157
Status:
TERMINATED
Last Update Posted:
2017-10-11
First Post:
2014-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
Interstitial Photodynamic Therapy During Standard Chemotherapy for Palliation of Patients With Head and Neck Squamous Cell Carcinoma - Phase II
Status:
TERMINATED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study no longer has an active IDE
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies the effects of interstitial photodynamic therapy in patients with head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may be an effective treatment for head and neck cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. Demonstrate that our image-guided interstitial photodynamic therapy (I-PDT) dosimetry system can be used to tailor this therapy to individual patients.
OUTLINE:
Patients receive porfimer sodium intravenously (IV) over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
After completion of study, patients are followed up at 1 month, 2 months, 4 months, and then every 2 months for up to 12 months.
I. Demonstrate that our image-guided interstitial photodynamic therapy (I-PDT) dosimetry system can be used to tailor this therapy to individual patients.
OUTLINE:
Patients receive porfimer sodium intravenously (IV) over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
After completion of study, patients are followed up at 1 month, 2 months, 4 months, and then every 2 months for up to 12 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-00210 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| I 235613 | OTHER | Roswell Park Cancer Institute | View | |
| P30CA016056 | NIH | None | https://reporter.nih.gov/quic… | View |