Recruiting
Phase 2

CLIPT with Verteporfin

Sponsor:

Rogers Sciences Inc.

Code:

NCT02939274

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Verteporfin

Continuous Low-Irradiance Photodynamic Therapy (CLIPT)

Study Details

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.

Conditions

Metastatic Breast Cancer

Study ID

NCT02939274

Start date

Oct, 2016

Status verified date

Jul, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Open Label

Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin

Interventions

Verteporfin

Continuous Low-Irradiance Photodynamic Therapy (CLIPT)

Primary outcome measure

  • Objective Response Rate [ Time Frame: Day 23 ]

Central Contacts and Locations

Central contacts

Steven J Isakoff, MD PhD

617 726 4920

Karleen Habin, RN

617 726 1922

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Steven J Isakoff, MD PhD

617-726-4920

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Beth Overmoyer, MD

617-632-3800

More Information

Sponsor

Rogers Sciences Inc.

Last update posted

Jul 20, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rogers Sciences Inc. on 2018-07-20.