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

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Breast Cancer

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Trial Information

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

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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Gary S. Rogers, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Rogers Sciences Inc.


United States: Institutional Review Board

Study ID:




Start Date:

December 2010

Completion Date:

August 2011

Related Keywords:

  • Breast Cancer
  • Chest wall progression breast cancer
  • PDT
  • Photofrin
  • Photosensitizer
  • Breast Neoplasms



Tufts Medical Center Boston, Massachusetts  02111