Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome

Not Recruiting

Trial ID: NCT00127881


The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.

Official Title

Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy

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)

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology


Inclusion Criteria:

   - A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive
   phenotype within 6 months of study entry

   - Refractory to or intolerant to at least two prior therapies, one being Targretin® (or
   combinations hereof).

   - Signed informed consent

Exclusion Criteria:

   - Prior treatment with Total Skin Electron Beam (TSEB) therapy within six months

   - Prior treatment with Campath (alemtuzumab)

   - Prior treatment with more than three regimens of single agent chemotherapy

   - Prior treatment with pentostatin within 6 months

   - Treatment within 4 weeks prior to visit 2 with topical Targretin®, skin directed
   therapies or systemic anticancer therapies, such as, but not limited to: Targretin® ,
   UV-light therapy, local Electron Beam Therapy (EBT), extracorporal photo chemotherapy,
   methotrexate, bleomycin, cyclophosphamide, combination chemotherapy, oral retinoids,
   systemic glucocorticosteroids , carmustine, nitrogen mustard, systemic vitamin A or

   - Treatment with topical glucocorticosteroids within 2 weeks prior to visit 2

   - Unwillingness or inability to avoid prolonged exposure to the sun or UV light
   sufficient to produce a mild erythema or thought by the investigator to likely modify
   the patient's disease

   - Concurrent or previous malignancies within the past five years except adequately
   treated in situ carcinoma of the uterine cervix or basal or squamous cell skin

   - Significant concurrent, uncontrolled, or active medical condition including, but not
   limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary,
   cardiac, neurological, cerebral or psychiatric disease

   - Known or suspected positive serology for HIV

   - Known or suspected positive serology for hepatitis B or C

   - Patients who are currently participating in any other trials or having received
   treatment with any experimental agent within 4 weeks prior to visit 1 (screening)

   - Prior treatment with anti-CD4 monoclonal antibodies

   - Breast feeding women or women with a positive pregnancy test at Visit 1

   - Women of childbearing potential not willing to use either hormonal birth control, an
   intrauterine device or double-barrier method for the entire study period


drug: HuMax-CD4 (Zanolimumab)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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