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

NCT00862901 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-09-26

No results posted yet for this study

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 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.

Conditions

Interventions

DEVICE

CLIPT patch

A Diomed laser will deliver 630nm (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. Patients will receive a single intravenous injection of Photofrin (0.8mg/kg body weight) 36 - 48 hours prior to the CLIPT procedure. PDT will be delivered over 24 hours for the dose of each arm. Patients will be enrolled in sequential cohorts of six, at increasing laser intensity until the maximum tolerated dose is reached.

Sponsors & Collaborators

  • Susan G. Komen Breast Cancer Foundation

    collaborator OTHER

  • Axcan Pharma

    collaborator INDUSTRY

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Roger Graham, MD · Tufts Medical Center, Department of Surgery

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-01-31
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00862901 on ClinicalTrials.gov