Trial | NCT02939274  Report issue

Title

An Open Label, Phase II Trial of Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin (Visudyne®) for the Treatment of Cutaneous Metastases of Breast Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    verteporfin ...

  • Study Participants

    15
The purpose of this Phase II study is to evaluate the efficacy and safety of Continuous Low- Irradiance Photodynamic Therapy (CLIPT) when used with Verteporfin in the treatment of cutaneous metastases of breast cancer for which no curative or significantly palliative therapy exists, including chest wall therapy.
Study Started
Oct 31
2016
Primary Completion
Dec 31
2018
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Jul 20
2018

Drug Verteporfin

Device Continuous Low-Irradiance Photodynamic Therapy (CLIPT)

  • Other names: CLIPT Illumination System

Open Label Other

Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin

Criteria 

Inclusion Criteria:

Histologically or cytologically confirmed Stage IIIb or IV breast cancer with cutaneous metastases.

Exclusion Criteria:

Participants receiving any medications or substances that are known to cause photosensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, fluoroquinolones, St. Johns' wort, amiodarone) are ineligible.
Participants who have received prior systemic therapy (chemotherapy or targeted therapy) within 7 days of Study Day 1 or those who have not recovered from clinically significant adverse events due to agents administered more than 7 days earlier. (continuation of the same regimen of HER-2 antibody targeted therapy agents, hormonal therapy and treatment with bisphosphonates or denosumab are permitted)
Participants who are receiving any other investigational agents during the proposed treatment cycle.
No Results Posted