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

July 24, 2012 updated by: Emergent Product Development Seattle LLC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon Cedex 02, France, 69288
        • Hopital de I'Hotel-Dieu
      • Nice, France, 06220
        • Consultation Dermatologie Niveau moins 1 Hopital Archet 2
      • Paris Cedex 10, France, 75475
        • Hopital Saint-Louis Service de Dermatologie
      • Pierre Benite Cedex, France, 69495
        • Centre Hospitalier Lyon Sud Bat. 1F 1er etage service Hematologie
  • Germany
      • Berlin, Germany, 10117
        • Skin Cancer Center Charite Mitte Dermatologie Fran Ramona Kursawa
      • Essen, Germany, 45122
        • University of Essen - Universitatsklinikum Essen z. Hd. Frau Desire Zieling
      • Kiel, Germany, D-24105
        • University of kiel, Klinik Fur Dermotologie, Christian-Albrechts-Universitat Zu
      • Minden, Germany, 32427
        • Klinikum Minden / Hautklinik Minden
      • Wurzburg, Germany, 97080
        • University of Wurzburg - Universitatsklinikum Wurzburg dermato-onkologische studien
  • Italy
      • Bologna, Italy, 40138
        • Instituto di Ematologia e Oncologia Medica "L. & A. Seragnoli"
      • Florence, Italy, 50121
        • Day Hospital Oncologico-Presidio Ospedaliero Firenze Centro Ospedale Santa Maria Nuova Azienda Sanitaria di Firenze, University of Florence
      • Milan, Italy, 20122
        • University of Milan-Fondazione IRCCS di Natura Pubblica Ospedale Maggiore Policlinico Mangiagalli e Regina Elena di Milano via Francesco Sforza
      • Roma, Italy, 00167
        • Instituto Dermopatico dell'Immacolata IRCCS via Monti di Creta
      • Turin, Italy, 10126
        • University of Turin SCDU Dermosifilopatia 2 A.S.O. Molinette S.Giovanni Battista
  • Spain
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28041
        • Maternidad Planta Baja, Hospital 12 de Octubre
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • University of Alabama at Birmingham
    • California
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Science Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center
    • New York
      • New York, New York, United States, 10016
        • New York Medical Center
      • New York City, New York, United States, 10021
        • Memorial Sloan Kettering
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospital of Cleveland
      • Columbus, Ohio, United States, 43201
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
    • Tennessee
      • Nashville, Tennessee, United States, 37212-2637
        • Middle Tennessee Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zanolimumab
Drug: HuMax-CD4 (zanolimumab)
Monoclonal Antibody, 12 weekly infusions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PGA Score
Time Frame: Duration of Study
Duration of Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emergent Product Development Seattle LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

August 8, 2005

First Submitted That Met QC Criteria

August 8, 2005

First Posted (Estimate)

August 9, 2005

Study Record Updates

Last Update Posted (Estimate)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hx-CD4-110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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