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

Purpose

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.

Condition

  • Metastatic Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Open Label 		Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin
  • Drug: Verteporfin
  • Device: Continuous Low-Irradiance Photodynamic Therapy (CLIPT)
    Other names:
    • CLIPT Illumination System

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Steven J Isakoff, MD PhD
617-726-4920

More Details

Status
Unknown status
Sponsor
Rogers Sciences Inc.

Study Contact

Steven J Isakoff, MD PhD
617 726 4920