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 : Unknown
Verified July 2018 by Rogers Sciences Inc..
Recruitment status was: Recruiting
First Posted : October 20, 2016
Last Update Posted : July 20, 2018
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Breast Cancer | Drug: Verteporfin Device: Continuous Low-Irradiance Photodynamic Therapy (CLIPT) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
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 |
Arm | Intervention/treatment |
---|---|
Open Label
Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin
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Drug: Verteporfin Device: Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Other Name: CLIPT Illumination System |
- 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 |
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.
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
Contact: Steven J Isakoff, MD PhD | 617 726 4920 | ||
Contact: Karleen Habin, RN | 617 726 1922 |
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 |
Principal Investigator: | Steven J Isakoff, MD PhD | Massachusetts General Hospital |
Responsible Party: | Rogers Sciences Inc. |
ClinicalTrials.gov Identifier: | NCT02939274 |
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 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Verteporfin Photosensitizing Agents Dermatologic Agents |