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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01262716
First Posted: December 17, 2010
Last Update Posted: October 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Tufts Medical Center
Information provided by:
Rogers Sciences Inc.
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer

Resource links provided by NLM:


Further study details as provided by Rogers Sciences Inc.:

Estimated Enrollment: 3
Study Start Date: December 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of 3 female patients. Eligible patients will be recruited from cancer centers in North America specializing in breast cancer. Recruitment has begun with the Hematology/Oncology, Dermatologic Oncology, and Radiation Oncology programs at Tufts Medical Center, Rhode Island Hospital and the teaching hospitals affiliated with Tufts and Brown Universities. All research related activity will only take place at the Tufts Medical Center.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262716


Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Rogers Sciences Inc.
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Tufts Medical Center
Investigators
Study Director: Gary S. Rogers, M.D. Rogers Sciences Inc.
Principal Investigator: Roger A. Graham, M.D. Tufts Medical Center
  More Information

Responsible Party: Samuel L Hill, Rogers Sciences Inc.
ClinicalTrials.gov Identifier: NCT01262716     History of Changes
Other Study ID Numbers: 9439
R43CA139644-01A1 ( U.S. NIH Grant/Contract )
First Submitted: December 15, 2010
First Posted: December 17, 2010
Last Update Posted: October 25, 2011
Last Verified: October 2011

Keywords provided by Rogers Sciences Inc.:
Chest wall progression breast cancer
PDT
Photofrin
Photosensitizer

Additional relevant MeSH terms:
Breast Neoplasms
Disease Progression
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes