Safety Study Using Photodynamic Therapy Light Therapy for Patients With Chest Wall Progression of Breast Cancer and Satellite Metastases of Melanoma

Completed · Phase 1

Conditions studied: Breast Cancer, Skin Cancer

In brief

This research is intended to explore a new approach to therapy when breast cancer recurs in the skin. The treatment, known as continuous low-irradiance photodynamic therapy, or CLIPT, has shown great promise in animal studies. The investigators goal is to evaluate CLIPT in people, using a novel light delivery system, to assess its side effects and the benefit it has in treating cancer. The investigators goal is to develop a safe, effective therapy that can be given in the doctor's office or possibly at home.

Key facts

Study ID

NCT00862901

Run by

Tufts Medical Center

People needed

48

Starts

2009-01-01

Expected to finish

2011-04-01

Last updated by the study team

2011-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients > 18 years of age, with primary or metastatic cutaneous tumors that have been previously irradiated.
• 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 for Target lesion, and 1 x 1 cm for Control site).
• 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 must sign informed consent.

You may not qualify if…

• 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.
• 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) will be excluded.
• Laboratory values (Note: these are provided by the potential patient):
• Absolute neutrophil count > 1000.
• Patients with severe hepatic dysfunction (total bilirubin, AST, or ALT > five times upper limit of normal) will be excluded.
• Adequate coagulation status as indicated by platelet count > 50,000, PT and PTT < 1.5 time the upper limit of normal.
• Negative Urine or Serum Pregnancy Test
• Note: No cost to patient, and no compensation provided.

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.