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
Trial Status: Active
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.
- Histologically or cytologically confirmed Stage IIIb or IV breast cancer with cutaneous metastases.
- 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.
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Massachusetts General Hospital Cancer Center
Contact: Steven Jay Isakoff
Trial Phase Phase II
Trial Type Treatment
Rogers Sciences Inc.
- Primary ID RSI-CLIPT-002
- Secondary IDs NCI-2017-01289
- Clinicaltrials.gov ID NCT02939274