A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer

This study will assess safety and ergonomics/engineering design of a novel cancer treatment, Continuous Low Irradiance Photodynamic therapy (CLIPT). We will assess the effects on primary and metastatic tumors involving the skin, in particular to improve the functionality, efficiency and wearability of the light delivery device (LDD) as well as the overall treatment in subjects with chest wall recurrences of breast cancer. An ongoing study (IRB# 8227), sponsored by a Susan G. Komen Breast Cancer Foundation grant, using a 1st generation LDD device has evaluated and determined a dose-limiting toxicity of CLIPT for subjects with chest wall recurrences of breast cancer.

A Diomed laser will be the device used in this study. The Diomed laser will deliver 630 nm (red spectrum) light through a Fiber Optic Patch. The Fiber Optic patch will be compatible with the laser, delivering light to a designated region on the patient's skin.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Anticipated): 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 3 female patients. Eligible patients will be recruited from cancer centers in North America specializing in breast cancer. Recruitment has begun with the Hematology/Oncology, Dermatologic Oncology, and Radiation Oncology programs at Tufts Medical Center, Rhode Island Hospital and the teaching hospitals affiliated with Tufts and Brown Universities. All research related activity will only take place at the Tufts Medical Center.

Description

Inclusion Criteria:

• Patients > 18 years of age, with primary or metastatic cutaneous tumors that may or may not have been previously irradiated.
• ECOG performance status < 3.
• Patients must not have received any systemic anti-cancer therapy within 30 days prior to enrolling in this study.
• Patients must not have received radiation therapy to the target site within 60 days of enrolling on this study.
• Skin of target site and control site must be grade 0 or 1 by Common Terminology
• Patients must have a target lesion and normal peri-umbilical skin that can be covered by the fiber-optic mesh used to deliver CLIPT (10 x 10 cm, or 3 x 3).
• If located on an extremity, the target lesion must not cover more than 50% of the diameter of the extremity at the level at which it is located.
• Absolute neutrophil count > 1000.
• Adequate coagulation status as indicated by platelet count > 50,000, PT and PTT < 1.5 time the upper limit of normal.
• Patients must sign informed consent.

Exclusion Criteria:

• Male patients not considered for this study.
• Patients must have a target lesion in a location other than the hands, feet, genitals, or face. Lesions in those locations will be excluded.
• Patients with medical conditions associated with photosensitivity, such as cutaneous porphyria or a collagen vascular disease, or with known allergies to porphyrins will be excluded.
• Pregnant and nursing patients will be excluded. Women of child-bearing potential must have a negative serum or urine pregnancy test prior to enrollment.
• Patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones, St. John's wort and amiodarone) will be excluded.
• Patients with severe hepatic dysfunction (total bilirubin, AST, or ALT > five times upper limit of normal) will be excluded.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Rogers Sciences Inc.
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH); Tufts Medical Center
• Investigators: Study Director: Gary S. Rogers, M.D., Rogers Sciences Inc.; Principal Investigator: Roger A. Graham, M.D., Tufts Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: December 15, 2010
• First Submitted That Met QC Criteria: December 16, 2010
• First Posted (Estimate): December 17, 2010

Study Record Updates

• Last Update Posted (Estimate): October 25, 2011
• Last Update Submitted That Met QC Criteria: October 24, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: PDT; Photofrin; Photosensitizer; Chest wall progression breast cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Disease Progression; Breast Neoplasms
• Other Study ID Numbers: 9439; R43CA139644-01A1 (U.S. NIH Grant/Contract)