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

NOT ENROLLING
Protocol # :
16-370
Conditions
Metastatic Breast Cancer
Phase
II
Disease Sites
Other Skin
Breast
Principal Investigator
Isakoff, Steven, J
Site Investigator
Overmoyer, Beth
Site Research Nurses
Beeler, Maureen

Trial Description

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.

Eligibility Requirements

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.

16-370