Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Emergent Product Development Seattle LLC

Stanford Investigator(s):

Intervention(s):

  • Drug: HuMax-CD4 (zanolimumab)

Phase:

Phase 3

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting