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

This study has been terminated.

(New sponsor, other treatments available)

Sponsor:

Information provided by (Responsible Party):

Emergent Product Development Seattle LLC

ClinicalTrials.gov Identifier:

NCT00127881

First received: August 8, 2005

Last updated: July 24, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 8, 2005
Last Updated Date	July 24, 2012
Start Date ^ICMJE	July 2005
Estimated Primary Completion Date	February 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 11, 2008)	PGA Score [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00127881 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Mycosis Fungoides Sezary Syndrome
Intervention ^ICMJE	Drug: HuMax-CD4 (zanolimumab) Monoclonal Antibody, 12 weekly infusions.
Study Arm (s)	Experimental: Zanolimumab Intervention: Drug: HuMax-CD4 (zanolimumab)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	76
Completion Date	Not Provided
Estimated Primary Completion Date	February 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, France, Germany, Italy, Spain

Administrative Information
NCT Number ^ICMJE	NCT00127881
Other Study ID Numbers ^ICMJE	Hx-CD4-110
Has Data Monitoring Committee	Yes
Responsible Party	Emergent Product Development Seattle LLC
Study Sponsor ^ICMJE	Emergent Product Development Seattle LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Emergent Product Development Seattle LLC
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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