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

July 18, 2018 updated by: Rogers Sciences Inc.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Steven J Isakoff, MD PhD
  • Phone Number: 617 726 4920

Study Contact Backup

  • Name: Karleen Habin, RN
  • Phone Number: 617 726 1922

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Steven J Isakoff, MD PhD
          • Phone Number: 617-726-4920
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
          • Beth Overmoyer, MD
          • Phone Number: 617-632-3800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: Day 23
To evaluate the objective response rate (ORR=CR+PR) at Day 23 (3 weeks) after the initial treatment. The objective response rate is defined as the rate of complete response (CR) plus the rate of partial response (PR).
Day 23

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rogers Sciences Inc.

Investigators

  • Principal Investigator: Steven J Isakoff, MD PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 18, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSI-CLIPT-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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