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
Unknown status
Sponsor: Rogers Sciences Inc.
Collaborators:
Information provided by (Responsible party):
Sponsor
ClinicalTrials.gov Identifier: NCT02939274
Protocol Info
Short Description: |
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 |
Long Description: |
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 |
MGH Status: |
Open |
Sponsor: |
DF/HCC |
Disease Program: |
Breast |
Next Steps
If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.
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 Title |
Intervention |
Phase |
Metastatic Breast Cancer
|
Verteporfin
Continuous Low-Irradiance Photodynamic Therapy (CL
|
Phase 2 |
Study Type |
Interventional |
Official Title |
|
Primary Outcome Measures
Objective Response Rate [Time Frame: Day 23] [Designated as safety issue: ]
Secondary Outcome Measures
Estimated Enrollment: |
15 |
Study Start Date: |
October 2016 |
Estimated Study Completion Date: |
December 2019 |
Estimated Primary Completion Date: |
December 2018 |
Arms |
Assigned Interventions |
Other:Open Label
Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin
|
Device:Continuous Low-Irradiance Photodynamic Therapy (CLIPT) |
Eligibility
Ages Eligible for Study: N/A-N/A
Genders Eligible for Study: All
Accepts Healthly 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.
More Information
No publications provided
Responsible Party: |
Sponsor
|
ClinicalTrials.gov Identifier: |
NCT02939274 |
Other Study ID Numbers: |
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Study First Received: |
|
Last Updated: |
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Health Authority: |
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Additional relevant MeSH terms:
Breast Neoplasms
Verteporfin
Next Steps
If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.
ClinicalTrials.gov processed this data on February 25, 2021