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

Mycosis Fungoides Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00127881
• Other study ID #: Hx-CD4-110
• Status: Terminated
• Phase: Phase 3
• First received: August 8, 2005
• Last updated: July 24, 2012
• Start date: July 2005

Study information

• Verified date: July 2012
• Source: Emergent Product Development Seattle LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 76
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mycoses
• Mycosis Fungoides
• Sezary Syndrome
• Syndrome

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Emergent Product Development Seattle LLC

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PGA Score		Duration of Study	No