Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome

Stopped early · Phase 3

Conditions studied: Mycosis Fungoides, Sezary Syndrome

In brief

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.

Key facts

Study ID

NCT00127881

Run by

Emergent Product Development Seattle LLC

People needed

76

Starts

2005-07-01

Last updated by the study team

2012-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• New York Medical Center — New York, New York, United States
• Memorial Sloan Kettering — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospital of Cleveland — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• Middle Tennessee Research Institute — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Hopital de I'Hotel-Dieu — Lyon, France
• Consultation Dermatologie Niveau moins 1 Hopital Archet 2 — Nice, France
• Hopital Saint-Louis Service de Dermatologie — Paris, France
• Centre Hospitalier Lyon Sud Bat. 1F 1er etage service Hematologie — Pierre-Bénite, France
• Skin Cancer Center Charite Mitte Dermatologie Fran Ramona Kursawa — Berlin, Germany
• University of Essen - Universitatsklinikum Essen z. Hd. Frau Desire Zieling — Essen, Germany

Full record on ClinicalTrials.gov

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