Clinical Trial - NCT02939274

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

Recruiting

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02939274

Locations

  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
    • Dana Farber Cancer Institute Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Rogers Sciences Inc.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02939274
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

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 April 09, 2020