Back to resultsAn Open Label, Phase II Trial of Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin (Visudyne®) for the Treatment of Cutaneous Metastases of Breast Cancer
Primary Purpose
Metastatic Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Verteporfin
Continuous Low-Irradiance Photodynamic Therapy (CLIPT)
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- Massachusetts General HospitalRecruiting
- Dana Farber Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Open Label
Arm Description
Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin
Outcomes
Primary Outcome Measures
Objective Response Rate
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02939274
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rogers Sciences Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open Label
Arm Type
Other
Arm Description
Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin
Intervention Type
Drug
Intervention Name(s)
Verteporfin
Intervention Type
Device
Intervention Name(s)
Continuous Low-Irradiance Photodynamic Therapy (CLIPT)
Other Intervention Name(s)
CLIPT Illumination System
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
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).
Time Frame
Day 23
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven J Isakoff, MD PhD
Phone
617 726 4920
First Name & Middle Initial & Last Name or Official Title & Degree
Karleen Habin, RN
Phone
617 726 1922
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Isakoff, MD PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven J Isakoff, MD PhD
Phone
617-726-4920
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Overmoyer, MD
Phone
617-632-3800
12. IPD Sharing Statement
Learn more about this trial
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
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