Clinical trial NCT00127881: Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Mycosis Fungoides
Sezary Syndrome
Keywords: 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
Lead sponsor: Emergent Product Development Seattle LLC
Sponsor class: INDUSTRY
First posted: 2005-08-09
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

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