MedDataX Logo

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

NCT ID: NCT01262716

Last Updated: 2011-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Tufts Medical Center

OTHER

Sponsor Role collaborator

Rogers Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rogers Sciences Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gary S. Rogers, M.D.

Role: STUDY_DIRECTOR

Rogers Sciences Inc.

Roger A. Graham, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R43CA139644-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9439

Identifier Type: -

Identifier Source: org_study_id