The purpose of this study is to learn the effects of an investigational medication, SGN 35, on patients with mycosis fungoides. Despite a wide range of therapeutic options, the treatments are associated with short response duration, thus this condition is largely incurable. This investigational drug may offer less toxicity than standard treatments and have better tumor specific targeting. The primary objective is to explore the biologic activity of brentuximab vedotin (SGN-35) in patients with mycosis fungoides (MF) and Sézary syndrome (SS), the most common group of cutaneous T-cell lymphoma (CTCL), where expression of CD30 is variable. SGN-35 has significant biologic activity in Hodgkin's disease (HD) where only a small numbers of CD30 positive tumor cells are present, as well as in lymphomas with large numbers of CD30-expressing tumor cells such as systemic anaplastic large cell lymphoma (sALCL).
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
a. Skin biopsy will be obtained within 3 months of beginning study medication, for assessment of CD30 expression by immunohistochemisty (IHC). This data will be used to ensure equal enrollment of patients in the 3 groups of varying CD30 expression (low, intermediate, high). If patient has different lesion morphology (patch, plaque, tumor), a biopsy will be obtained from each morphologic lesion. If the patient has one type of lesion morphology, a biopsy from 2 separate anatomic sites will be obtained.
b. The highest CD30 expression value among biopsies will be used to determine which of the 3 groups the subject will be assigned to.
1. >= 3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anti-cancer investigational agents (includingmonoclonal antibody).
2. > 3 weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox.
3. > 3 wks for phototherapy.
4. > 2 wks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod).
Stanford University School of Medicine
300 Pasteur Drive, Stanford, CA 94305
Mary Chen, 650.421.6370, email@example.com
Principal Investigator: Youn H. Kim, M.D.
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