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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emergent Product Development Seattle LLC
• Treatments: Antibodies, Monoclonal; Zanolimumab

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