Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level

Inclusion Criteria:

   - Biopsy-proven MF/SS, stage IB-IVB, and failed one standard systemic therapy. Skin
   biopsy must be within 3 months of beginning study medication

   - At least the following wash-out from prior treatments:

      - ≥ 3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy,
      treatment with other anti-cancer investigational agents (including monoclonal
      antibody)

      - > 3 weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox
      and phototherapy

      - > 2 wks for topical therapy (including topical steroid, retinoid, nitrogen
      mustard, or imiquimod)

   - At least 18 years of age

   - ECOG performance status of ≤ 2

   - Must be able to commit to study schedule

   - Absolute neutrophil count (ANC) ≥ 1000/uL

   - Platelets ≥ 50,000/uL

   - Bilirubin ≤ 2X upper limit of normal (ULN) (EXCEPTION: Gilbert's disease ≤ 3X ULN)

   - Serum creatinine ≤ 2X ULN

   - Alanine aminotransferase (ALT) ≤ 3X ULN

   - Aspartate aminotransferase (AST) ≤ 3X ULN

   - Negative serum beta-HCG pregnancy test result within 7 days of first treatment, if a
   woman of childbearing potential

   - Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

   - Mycosis fungoides (MF) with limited disease (stage IA) or central nervous system (CNS)
   disease

   - Systemic or topical concomitant corticosteroid use for treatment of skin disease
   (EXCEPTION: Oral prednisone allowed at ≤ 10 mg/day)

   - Known Grade 3 or higher (per NCI CTCAE v4.0 criteria) active systemic or cutaneous
   viral, bacterial, or fungal infection

   - Known to be Hepatitis B or Hepatitis C antibody positive

   - HIV-positive with have a measurable viral load while on antiretroviral medication

   - Known hypersensitivity to recombinant proteins or any excipient contained in the drug
   formulation.

   - History of other malignancies during the past 3 years (EXCEPTIONS: non-melanoma skin
   cancer; curatively treated localized prostate cancer; curatively treated localized
   breast cancer; resected thyroid cancer; cervical intraepithelial neoplasia; or
   cervical carcinoma in situ on biopsy).

   - Pregnant

   - Breastfeeding

   - Congestive heart failure, Class III or IV, by New York Heart Association (NYHA)
   criteria.

   - Any serious underlying medical condition that would impair subject's ability to
   receive or tolerate the planned treatment.

   - Dementia or altered mental status that would preclude subject's understanding and
   rendering of informed consent.