Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level
Condition: Non-Hodgkin Lymphoma (NHL); Cutaneous Lymphoma; Cutaneous T-cell Lymphoma (CTCL); Mycosis Fungoides; Sezary Syndrome
MeSH terms: Mycoses; Lymphoma; Lymphoma, Non-Hodgkin; Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous
Intervention: Brentuximab vedotin
Intervention description: 1.8 mg/kg by IV every 3 weeks for a maximum of 16 doses (8 cycles).
Brentuximab vedotin is an antibody conjugate, consisting of the chimeric IgG1 anti-CD30 antibody cAC10; the microtubule disrupting agent monomethyl auristatin E (MMAE); a protease-cleavable linker that covalently attaches MMAE to cAC10.
Intervention MeSH terms: Brentuximab Vedotin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an
      investigational medication, on patients with cutaneous T cell lymphoma (CTCL), specifically
      mycosis fungoides (MF) and Sezary syndrome (SS). 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.
    

Eligibility criteria:

        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.