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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00127881
Recruitment Status : Terminated (New sponsor, other treatments available)
First Posted : August 9, 2005
Last Update Posted : July 26, 2012
Sponsor:
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mycosis Fungoides Sezary Syndrome Drug: HuMax-CD4 (zanolimumab) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2005
Estimated Primary Completion Date : February 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Zanolimumab Drug: HuMax-CD4 (zanolimumab)
Monoclonal Antibody, 12 weekly infusions.


Outcome Measures
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Primary Outcome Measures :
  1. PGA Score [ Time Frame: Duration of Study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127881


Locations
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Sponsors and Collaborators
Emergent Product Development Seattle LLC
More Information
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Responsible Party: Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier: NCT00127881    
Other Study ID Numbers: Hx-CD4-110
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: July 2012
Keywords provided by Emergent Product Development Seattle LLC:
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
Additional relevant MeSH terms:
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Mycoses
Mycosis Fungoides
Sezary Syndrome
Syndrome
Disease
Pathologic Processes
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
 Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Zanolimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents