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

Not Recruiting

Trial ID: NCT01396070


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.

Official Title

Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level

Stanford Investigator(s)

Youn H Kim, MD
Youn H Kim, MD

The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)

Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology

Christina Kong
Christina Kong

Professor of Pathology

Seema Nagpal, MD
Seema Nagpal, MD

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology


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

      - > 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)

   - 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

   - 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)

   - 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.


drug: Brentuximab vedotin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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