Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome
- Conditions
- Mycosis FungoidesSezary Syndrome
- Interventions
- Registration Number
- NCT00127881
- Lead Sponsor
- Emergent Product Development Seattle LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 76
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zanolimumab HuMax-CD4 (zanolimumab) -
- Primary Outcome Measures
Name Time Method PGA Score Duration of Study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Tulane University Health Science Center
🇺🇸New Orleans, Louisiana, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Memorial Sloan Kettering
🇺🇸New York City, New York, United States
Scroll for more (25 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States