Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome - Full Text View

Sponsor:	Genmab
Information provided by:	Genmab
ClinicalTrials.gov Identifier:	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.

Condition	Intervention	Phase
Mycosis Fungoides Sezary Syndrome	Drug: HuMax-CD4 (zanolimumab)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open Label, Dose Escalation, Followed by Open Label,Single Arm, Multi-Center Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, 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

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Lymphoma

Drug Information available for: Immunoglobulins Zanolimumab Globulin, Immune

U.S. FDA Resources

Further study details as provided by Genmab:

Primary Outcome Measures:

PGA Score [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]

Estimated Enrollment:	92
Study Start Date:	July 2005
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Monoclonal Antibody, 12 weekly infusions.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881

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Locations

United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
The Emory Clinic
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Louisiana
Tulane University Health Science Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, New York
New York Medical Center
New York, New York, United States, 10016
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Memorial Sloan Kettering
New York City, New York, United States, 10021
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospital of Cleveland
Cleveland, Ohio, United States, 44106
Ohio State University
Columbus, Ohio, United States, 43201
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Middle Tennessee Research Institute
Nashville, Tennessee, United States, 37212-2637
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
France
Hopital Saint-Louis Service de Dermatologie
Paris Cedex 10, France, 75475
Consultation Dermatologie Niveau moins 1 Hopital Archet 2
Nice, France, 06220
Centre Hospitalier Lyon Sud Bat. 1F 1er etage service Hematologie
Pierre Benite Cedex, France, 69495
Hopital de I'Hotel-Dieu
Lyon Cedex 02, France, 69288
Germany
Skin Cancer Center Charite Mitte Dermatologie Fran Ramona Kursawa
Berlin, Germany, 10117
University of kiel, Klinik Fur Dermotologie, Christian-Albrechts-Universitat Zu
kiel, Germany, D-24105
University of Essen - Universitatsklinikum Essen z. Hd. Frau Desire Zieling
Essen, Germany, 45122
University of Wurzburg - Universitatsklinikum Wurzburg dermato-onkologische studien
Wurzburg, Germany, 97080
Klinikum Minden / Hautklinik Minden
Minden, Germany, 32427
Italy
Instituto di Ematologia e Oncologia Medica "L. & A. Seragnoli"
Bologna, Italy, 40138
University of Turin SCDU Dermosifilopatia 2 A.S.O. Molinette S.Giovanni Battista
Turin, Italy, 10126
Day Hospital Oncologico-Presidio Ospedaliero Firenze Centro Ospedale Santa Maria Nuova Azienda Sanitaria di Firenze, University of Florence
Florence, Italy, 50121
Instituto Dermopatico dell'Immacolata IRCCS via Monti di Creta
Roma, Italy, 00167
University of Milan-Fondazione IRCCS di Natura Pubblica Ospedale Maggiore Policlinico Mangiagalli e Regina Elena di Milano via Francesco Sforza
Milan, Italy, 20122
Spain
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Maternidad Planta Baja, Hospital 12 de Octubre
Madrid, Spain, 28041

Sponsors and Collaborators

Genmab

More Information

No publications provided

Responsible Party:	Genmab A/S ( Project Manager )
Study ID Numbers:	Hx-CD4-110
Study First Received:	August 8, 2005
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00127881 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Italy:; Spain:; France:; Italy:

Keywords provided by Genmab:

Refractory or intolerant to Mycosis Fungoides and sezary syndrome
Cutaneous T-cell Lymphoma
To evaluate the efficacy and safety of zanolimumab in Mycosis Fungoides and sezary syndrome

Additional relevant MeSH terms:

Disease
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Sezary Syndrome
Mycosis Fungoides
Pharmacologic Actions
Antibodies, Monoclonal
Mycoses

Lymphatic Diseases
Antibodies
Neoplasms
Pathologic Processes
Syndrome
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on November 30, 2009