Clinical Trial Review

Mycosis fungoides (MF) and its leukemic variant Sezary syndrome (SS) are the most prevalent forms of CTCL. While early stage MF is restricted to patches and plaques involving the skin, most patients eventually develop cutaneous tumors, generalized erythroderma, or dissemination to peripheral blood, lymph nodes, or visceral organs. Currently existing therapy of tumor-stage and disseminated CTCL is palliative, with most patients dying within 1-5 years.

This study will investigate the safety and effectiveness of a modified donor stem cell transplantation procedure for treating advanced MF and SS. Patients with advanced MF or SS who are between 18 and 70 years of age and have a matched family donor 18 years of age or older may be eligible for this study. Stem cells will be collected from both the patient and donor. To do this, the hormone G-CSF will be injected under the skin for several days to push stem cells out of the bone marrow into the bloodstream. Then, the stem cells will be collected by apheresis. The anticipated hospital stay is 3 to 4 days, when the first 3 doses of Campath will be monitored for drug side effects. The rest of the procedures, including the transplant, can be done on an outpatient basis.

The purpose of this trial is to see if a topical beta blocker is effective in preventing the proliferation of infantile hemangioma. Infantile hemangiomas (IH) are among the most common, benign vascular tumors of infancy with an estimated prevalence of 4% to 5% of the population. IH are not found at birth but become evident within the first few weeks of life. Although frequently thought of as benign lesions, hemangiomas can occur in locations to cause functional impairment of vital organs, can lead to ulcerations, scarring, or disfigurement, and can lead to life-threatening complications.

For periorbital lesions that may cause amblyopia or anisometropia, topical Timolol has been reported to be of benefit. The investigators find it reasonable to start treatment with a topical beta blocker at an early stage of hemangioma to prevent the growth and proliferation and hence the possible severe effects associated with growth and thus impairment of vital organs/tissues. The advantage of a topical therapy is the decreased risk of systemic side effects compared with oral or intravenous administration. The disadvantage is that limited penetration may preclude effectiveness for the thicker or deeper lesions.

The purpose of this multicenter study is to determine whether Pico laser is effective and safe in the treatment of unwanted tattoos. The Investigational device is a dual wavelength laser system developed for treatment of pigmented lesions and for tattoo removal. The base unit is a GentleMax Pro laser system modified to emit light at wavelengths of 532 and 1064 nm and deliver pulse energy up to 400mJ, and pulse duration of 700 ps.

Three months after the final treatment, the global percentage of tattoo clearance will be evaluated by blinded observers using post-treatment photographs compared with baseline photographs. The average number of treatments will be determined in order to obtain 50% and 75% tattoo clearance. Rate of clearance will be assessed globally, independent of tattoo color and based on individual colors. Adverse events will be evaluated immediately after and before each subsequent laser treatment, and will be based on the incidence and severity of side effects caused by the laser treatments.