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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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ClinicalTrials.gov Identifier: NCT02939274
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Rogers Sciences Inc.

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Verteporfin Device: Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Verteporfin

Arm Intervention/treatment
Open Label
Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin
Drug: Verteporfin
Device: Continuous Low-Irradiance Photodynamic Therapy (CLIPT)
Other Name: CLIPT Illumination System




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939274


Contacts
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Contact: Steven J Isakoff, MD PhD 617 726 4920
Contact: Karleen Habin, RN 617 726 1922

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Steven J Isakoff, MD PhD    617-726-4920      
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Beth Overmoyer, MD    617-632-3800      
Sponsors and Collaborators
Rogers Sciences Inc.
Investigators
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Principal Investigator: Steven J Isakoff, MD PhD Massachusetts General Hospital

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Responsible Party: Rogers Sciences Inc.
ClinicalTrials.gov Identifier: NCT02939274     History of Changes
Other Study ID Numbers: RSI-CLIPT-002
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Verteporfin
Photosensitizing Agents
Dermatologic Agents