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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Rogers Sciences Inc.
Study ID
NCT02939274
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Verteporfin — DRUG
  • Continuous Low-Irradiance Photodynamic Therapy (CLIPT) — DEVICE

Study Details

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.

Key Dates

Start date
Oct 31, 2016
Status verified
Jul 2018
Primary completion
Dec 31, 2018
Completion
Dec 31, 2019

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Open Label
    Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin

Primary Outcome Measure

Objective Response Rate [ Time Frame: Day 23 ]

Central Contacts

  • Steven J Isakoff, MD PhD
    617 726 4920
  • Karleen Habin, RN
    617 726 1922

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Beth Overmoyer, MD
617-632-3800
Massachusetts General HospitalBostonMassachusetts02114
Steven J Isakoff, MD PhD
617-726-4920

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