Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome - Full Text View

Sponsor:	TenX BioPharma
Information provided by:	TenX BioPharma
ClinicalTrials.gov Identifier:	NCT00127881

Purpose

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	Intervention	Phase
Mycosis Fungoides Sezary Syndrome	Drug: HuMax-CD4 (zanolimumab)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open Label, Dose Escalation, Followed by Open Label,Single Arm, Multi-center Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, 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

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Lymphoma

U.S. FDA Resources

Further study details as provided by TenX BioPharma:

Primary Outcome Measures:

PGA Score [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]

Estimated Enrollment:	92
Study Start Date:	July 2005
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Monoclonal Antibody, 12 weekly infusions.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881

Contacts

Contact: Maurice Briggs

(267) 479-0538

info@tenxbiopharma.com

Show 38 Study Locations

Sponsors and Collaborators

TenX BioPharma

More Information

No publications provided

Responsible Party:	Project Manager, TenX Biopharma
ClinicalTrials.gov Identifier:	NCT00127881 History of Changes
Other Study ID Numbers:	Hx-CD4-110
Study First Received:	August 8, 2005
Last Updated:	June 17, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by TenX BioPharma:

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
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
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012