by Madeline Duvic, MD
Professor of Medicine and Dermatology
Deputy Chair, Dermatology, University of Texas, MD Anderson Cancer Center
As primary investigator, I am leading a group of physicians who are currently developing a clinical trial to prospectively evaluate the effectiveness of photopheresis in treating early stage CTCL (Stage IA – IIA). During photopheresis the white blood cell (WBC) fraction of a patient’s whole blood is collected using a specially designed apheresis instrument. It is the WBC fraction that contains the abnormal lymphocytes seen in CTCL. Following collection, the WBC fraction is mixed with a photosensitizing drug known as UVADEX (Methoxsalen) and exposed to UVA light. The treated cells are then returned to the patient where they are believed to undergo apoptosis or natural cell death. Although the exact mechanism of action remains unclear, these apoptotic WBC’s seem to stimulate the patient’s immune system too more effectively fight the CTCL.
Photopheresis was the first FDA approved therapy for treating CTCL. Clinical trials performed in the late 80’s demonstrated the safety and efficacy of photopheresis to treat CTCL. These studies focused primarily on late stage (IIB-IV) CTCL. At that time it was believed, based on available laboratory tests, that only late stage CTCL patients had abnormal circulating lymphocytes in their blood. Since photopheresis needs cells circulating in the blood to be able to collect and treat them, only late stage CTCL was studied. Today, with more sensitive diagnostic tests, it has been demonstrated that even early stage CTCL patients have circulating abnormal lymphocytes in their blood. In addition, retrospective results published in the scientific literature indicate that photopheresis may be efficacious in treating the skin manifestations of early stage CTCL.
General inclusion criteria for this study will be as follows:
1. Must be CTCL stage IA, IB or IIA
2. Presence of measurable CTCL skin lesions
3. Have a positive skin biopsy diagnostic of CTCL
4. Must weigh at least 40KG and have adequate veins for intravenous access
Please continue to monitor future issues of this newsletter for more information on this study and study site locations. For more information on photopheresis you may also reference the photopheresis website at therakos.com.