Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level
1. Patient has biopsy-proven MF/SS, stage IB-IVB, and failed one standard systemic
- Skin biopsy will be obtained within 3 months of beginning study medication, for
assessment of CD30 expression by immunohistochemistry (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.
- The highest CD30 expression value among biopsies will be used to determine which
of the 3 groups the subject will be assigned to.
2. Patients must have the following minimum wash-out from previous 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
- > 3 wks for phototherapy.
- > 2 wks for topical therapy (including topical steroid, retinoid, nitrogen
mustard, or imiquimod).
3. At least 18 years of age.
4. ECOG performance status of <= 2.
5. Patients must be available for study treatment, blood sampling, study assessments,
and management of toxicity at the treating institution.
6. Adequate baseline laboratory data: absolute neutrophil count (ANC) >= 1000/uL,
platelets >= 50,000/uL, bilirubin <= 2X upper limit of normal (ULN) or <= 3X ULN
for patients with Gilbert's disease, serum creatinine <= 2X ULN, alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3X ULN.
7. Women of childbearing potential (WOCBP) must have a negative serum beta-HCG pregnancy
test result within seven days of treatment.
8. Ability to understand and the willingness to sign a written informed consent
1. Patients with mycosis fungoides (MF) with limited disease (stage IA) or central
nervous system (CNS) disease.
2. Concomitant corticosteroid use, systemic or topical, for treatment of skin disease.
Oral prednisone is allowed at <= 10 mg/day, if patient has been on a stable dose for
at least 1 month prior to study entry.
3. Patients with known Grade 3 or higher (per NCI CTCAE v4.0 criteria) active systemic
or cutaneous viral, bacterial, or fungal infection.
4. Patients who are known to be Hepatitis B or Hepatitis C antibody positive.
5. Patients who are HIV-positive, and have a measurable viral load while on
6. Patients with a known hypersensitivity to recombinant proteins or any excipient
contained in the drug formulation.
7. Patients with a history of other malignancies during the past three years. (The
following are exempt from the three-year limit: 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).
8. Patients who are currently pregnant or breastfeeding.
9. Patients with congestive heart failure, Class III or IV, by New York Heart
Association (NYHA) criteria.
10. Patients with any serious underlying medical condition that would impair their
ability to receive or tolerate the planned treatment.
11. Patients with dementia or altered mental status that would preclude understanding and
rendering of informed consent.