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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262716
• Other study ID #: 9439
• Secondary ID: R43CA139644-01A1
• Status: Completed
• Phase: N/A
• First received: December 15, 2010
• Last updated: October 24, 2011
• Start date: December 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• Source: Rogers Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Rogers Sciences Inc.	National Cancer Institute (NCI), National Institutes of Health (NIH), Tufts Medical Center

Country where clinical trial is conducted

United States,