Status:
COMPLETED
A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer
Lead Sponsor:
Rogers Sciences Inc.
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
Brief 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 metastati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01262716
Start Date
December 1 2010
End Date
August 1 2011
Last Update
October 25 2011
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111