Study Stopped
New sponsor, other treatments available
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome
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
1 other identifier
interventional
76
5 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 8, 2005
CompletedFirst Posted
Study publicly available on registry
August 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedJuly 26, 2012
July 1, 2012
8.6 years
August 8, 2005
July 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PGA Score
Duration of Study
Study Arms (1)
Zanolimumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University Medical Center
Stanford, California, 94305, United States
University of Colorado
Aurora, Colorado, 80045, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
Tulane University Health Science Center
New Orleans, Louisiana, 70112, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
New York Medical Center
New York, New York, 10016, United States
Memorial Sloan Kettering
New York, New York, 10021, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University Hospital of Cleveland
Cleveland, Ohio, 44106, United States
Ohio State University
Columbus, Ohio, 43201, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Middle Tennessee Research Institute
Nashville, Tennessee, 37212-2637, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Hopital de I'Hotel-Dieu
Lyon, 69288, France
Consultation Dermatologie Niveau moins 1 Hopital Archet 2
Nice, 06220, France
Hopital Saint-Louis Service de Dermatologie
Paris, 75475, France
Centre Hospitalier Lyon Sud Bat. 1F 1er etage service Hematologie
Pierre-Bénite, 69495, France
Skin Cancer Center Charite Mitte Dermatologie Fran Ramona Kursawa
Berlin, 10117, Germany
University of Essen - Universitatsklinikum Essen z. Hd. Frau Desire Zieling
Essen, 45122, Germany
University of kiel, Klinik Fur Dermotologie, Christian-Albrechts-Universitat Zu
Kiel, D-24105, Germany
Klinikum Minden / Hautklinik Minden
Minden, 32427, Germany
University of Wurzburg - Universitatsklinikum Wurzburg dermato-onkologische studien
Würzburg, 97080, Germany
Instituto di Ematologia e Oncologia Medica "L. & A. Seragnoli"
Bologna, 40138, Italy
Day Hospital Oncologico-Presidio Ospedaliero Firenze Centro Ospedale Santa Maria Nuova Azienda Sanitaria di Firenze, University of Florence
Florence, 50121, Italy
University of Milan-Fondazione IRCCS di Natura Pubblica Ospedale Maggiore Policlinico Mangiagalli e Regina Elena di Milano via Francesco Sforza
Milan, 20122, Italy
Instituto Dermopatico dell'Immacolata IRCCS via Monti di Creta
Roma, 00167, Italy
University of Turin SCDU Dermosifilopatia 2 A.S.O. Molinette S.Giovanni Battista
Turin, 10126, Italy
Hospital Universitario de la Princesa
Madrid, 28006, Spain
Maternidad Planta Baja, Hospital 12 de Octubre
Madrid, 28041, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2005
First Posted
August 9, 2005
Study Start
July 1, 2005
Primary Completion
February 1, 2014
Last Updated
July 26, 2012
Record last verified: 2012-07