This phase 3 clinical trial will test the effectiveness of topical SGX301 (synthetic hypericin) in treating patch or plaque phase mycosis fungoides. The primary outcome will be measured by the treatment response.
The details
Mycosis fungoides cutaneous T-cell lymphoma (CTCL), is a cancer of T-cells involving the skin. During the patch phase a flat, rash-like lesion forms on the skin. In the plaque phase, these lesions become thicker and raised. SGX301 is a topical anti-cancer therapy that is activated by fluorescent light. It inhibits (blocks the function of) proteins involved in cell growth and division, resulting in the death of cancer cells. SGX301 is applied directly to the lesion and is activated when exposed to safe fluorescent light. This avoids the risk of acquiring secondary cancers, such as melanoma, which can be caused by other light activated therapies that require use of harmful ultraviolet (UV) light.
The study will examine the treatment response in 3 lesions over 8 weeks. It will also measure complete responses, degree of improvement, time to relapse, and adverse (negative) effects.
Who are they looking for?
This trial is recruiting 120 patients with stage 1a, 1b, or 2a mycosis fungoides with a minimum of three lesions. Ideal candidates should not receive topical steroids 2 weeks prior to treatment or systemic steroids, CTCL treatments, or UVA/B within 3 weeks of enrollment. Patients should not have a history of systemic immunosuppression.
How will it work
The trial will include 3 cycles containing 6 weeks of treatment followed by a 2 week rest period. During cycle 1, patients will be divided into 2 groups. One group will receive SGX301 treatment applied to 3 lesions, and the other group will receive a placebo (substance with no active effect). In cycle 2 and 3 all patients will receive treatment to 3 lesions. After the last cycle is complete, patients will have the option to continue treatment for all lesions.
SGX301 ointment will be applied to the lesions twice a week and covered by a bandage for 12-24 hours before it is exposed to fluorescent light.
