The first goal of the Phase 1 study was to find the maximum tolerated dose (MTD) of increasing amounts of both red light and the topical photosensitizer Silicon pthaloryanine 4 (Pc4) ClinicalTrials.gov A biological response in the T-cell lymphoma involved skin was noted in each of our patients, and an MTD was successfully determined. Now the study moves to a second phase in which the red light (Photomedex) is fractionated into multiple pulses during a single course of treatment. The trial is sponsored by the FDA’s Office of Rare Diseases Orphan Product Development program and builds upon prior research suggesting that Pc4 PDT selectively targets activated and malignant T-cells, penetrates the skin, is safe in mammals and has activity in cutaneous T-cell lymphoma. (Baron, ED, Lam, M. Lasers in Surgery & Medicine)
The study is led by Dr. Elma Baron, Professor of Dermatology, Case Western Reserve University and Director of the Skin Study Center at University Hospitals Cleveland Medical Center (more about Dr. Baron) in collaboration with Dr. Kevin Cooper, Professor & Chair, Case Western Reserve University and University Hospitals Cleveland Medical Center (more about Dr. Cooper) and Dr. Minh Lam, Assistant Professor, Case Western Reserve University (more about Dr. Lam).
The University Hospitals/Case Medical Center Multidisciplinary Cutaneous Oncology Program is an integral part of excellent care for patients with cutaneous lymphoma in our Health System, as well as a regional, national and international referral center. A weekly conference is co-attended by nursing, dermatology, radiation oncology, medical oncology and dermatopathology. Through integrating patient care across departments, our cutaneous lymphoma specialized clinicians are able to discuss state-of-the art histochemical stains, molecular tools and clinical information to properly diagnose and manage patients in the program. This allows for timely dialogue among the providers, consensus and excellent continuity of care across disciplines.
Since its inception in 1996, we have presented over 900 patients at conference with diagnoses ranging from mycosis fungoides (the most common cutaneous lymphoma diagnosis), to subgroups including B-cell lymphomas, CD30+ lymphomas and rare variants such as lymphomatoid papulosis, NK/T-cell lymphomas and peripheral T-cell lymphomas. In addition to complex diagnoses and care path therapies, our cutaneous oncology conference allows for referrals to investigative protocols and clinical trials that might otherwise not be available to our patients.
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