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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/22/2018
Start Date:October 2016
End Date:December 2019
Contact:Steven J Isakoff, MD PhD
Phone:617 726 4920

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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.


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.
We found this trial at
2
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-3800
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-4920
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