Status:
COMPLETED
Safety Study Using Photodynamic Therapy Light Therapy for Patients With Chest Wall Progression of Breast Cancer and Satellite Metastases of Melanoma
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Susan G. Komen Breast Cancer Foundation
Axcan Pharma
Conditions:
Breast Cancer
Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
The goal of this research is to conduct a Phase I clinical study to assess the toxicity, safety and feasibility of a novel cancer treatment, Continuous Low Irradiance Photodynamic Therapy (CLIPT). Thi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00862901
Start Date
January 1 2009
End Date
April 1 2011
Last Update
September 26 2011
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111