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Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome
Not Recruiting
Trial ID: NCT00127881
Purpose
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
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)
Richard Hoppe
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Eligibility
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
etretinate
- 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
carcinoma
- 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
Intervention(s):
drug: HuMax-CD4 (Zanolimumab)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061