Status:
TERMINATED
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome
Lead Sponsor:
Emergent Product Development Seattle LLC
Conditions:
Mycosis Fungoides
Sezary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Targ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00127881
Start Date
July 1 2005
Last Update
July 26 2012
Active Locations (35)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States
2
Stanford University Medical Center
Stanford, California, United States, 94305
3
University of Colorado
Aurora, Colorado, United States, 80045
4
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612