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

Sponsor
Emergent Product Development Seattle LLC (Industry)
Overall Status
Terminated
CT.gov ID
NCT00127881
Collaborator
(none)
76
Enrollment
35
Locations
1
Arm
2.2
Patients Per Site

Study Details

Study Description

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
  • Drug: HuMax-CD4 (zanolimumab)
 Phase 3

Study Design

Study Type:
Interventional
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 :
Jul 1, 2005
Anticipated Primary Completion Date :
Feb 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Zanolimumab

Drug: HuMax-CD4 (zanolimumab)
Monoclonal Antibody, 12 weekly infusions.

Outcome Measures

Primary Outcome Measures

  1. PGA Score [Duration of Study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

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

Sponsors and Collaborators

  • Emergent Product Development Seattle LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier:
NCT00127881
Other Study ID Numbers:
  • Hx-CD4-110
First Posted:
Aug 9, 2005
Last Update Posted:
Jul 26, 2012
Last Verified:
Jul 1, 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:
Mycoses
Mycosis Fungoides
Sezary Syndrome
Syndrome
Zanolimumab

Study Results

No Results Posted as of Jul 26, 2012