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 Colorado
🇺🇸Aurora, Colorado, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University Hospital of Cleveland
🇺🇸Cleveland, Ohio, United States
Middle Tennessee Research Institute
🇺🇸Nashville, Tennessee, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Tulane University Health Science Center
🇺🇸New Orleans, Louisiana, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Consultation Dermatologie Niveau moins 1 Hopital Archet 2
🇫🇷Nice, France
University of kiel, Klinik Fur Dermotologie, Christian-Albrechts-Universitat Zu
🇩🇪Kiel, Germany
Day Hospital Oncologico-Presidio Ospedaliero Firenze Centro Ospedale Santa Maria Nuova Azienda Sanitaria di Firenze, University of Florence
🇮🇹Florence, Italy
University of Milan-Fondazione IRCCS di Natura Pubblica Ospedale Maggiore Policlinico Mangiagalli e Regina Elena di Milano via Francesco Sforza
🇮🇹Milan, Italy
Skin Cancer Center Charite Mitte Dermatologie Fran Ramona Kursawa
🇩🇪Berlin, Germany
University of Essen - Universitatsklinikum Essen z. Hd. Frau Desire Zieling
🇩🇪Essen, Germany
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Memorial Sloan Kettering
🇺🇸New York City, New York, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
New York Medical Center
🇺🇸New York, New York, United States
Centre Hospitalier Lyon Sud Bat. 1F 1er etage service Hematologie
🇫🇷Pierre Benite Cedex, France
Hopital Saint-Louis Service de Dermatologie
🇫🇷Paris Cedex 10, France
Hopital de I'Hotel-Dieu
🇫🇷Lyon Cedex 02, France
Klinikum Minden / Hautklinik Minden
🇩🇪Minden, Germany
University of Wurzburg - Universitatsklinikum Wurzburg dermato-onkologische studien
🇩🇪Wurzburg, Germany
Instituto di Ematologia e Oncologia Medica "L. & A. Seragnoli"
🇮🇹Bologna, Italy
University of Turin SCDU Dermosifilopatia 2 A.S.O. Molinette S.Giovanni Battista
🇮🇹Turin, Italy
Instituto Dermopatico dell'Immacolata IRCCS via Monti di Creta
🇮🇹Roma, Italy
Maternidad Planta Baja, Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain