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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

Sponsor
Rogers Sciences Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02939274
Collaborator
(none)
15
Enrollment
2
Locations
1
Arm
38
Duration (Months)
7.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Open Label

Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin

Drug: Verteporfin

Device: Continuous Low-Irradiance Photodynamic Therapy (CLIPT)
Other Names:
  • CLIPT Illumination System

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy 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

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114
    2 Dana Farber Cancer Institute Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Rogers Sciences Inc.

    Investigators

    • Principal Investigator: Steven J Isakoff, MD PhD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rogers Sciences Inc.
    ClinicalTrials.gov Identifier:
    NCT02939274
    Other Study ID Numbers:
    • RSI-CLIPT-002
    First Posted:
    Oct 20, 2016
    Last Update Posted:
    Jul 20, 2018
    Last Verified:
    Jul 1, 2018
    Additional relevant MeSH terms:
    Breast Neoplasms
    Verteporfin

    Study Results

    No Results Posted as of Jul 20, 2018