Clinical Trial of HuMax-CD4, a New Drug to Treat Advanced Stage T-Cell Lymphoma in the Skin. - Full Text View

Purpose

The purpose of this trial is to determine the effect of HuMax-CD4, as a treatment for advanced stage (late stage) cutaneous T-cell lymphoma (CTCL). Almost all patients who are affected by late stage CTCL have many cancerous cells which bear a receptor called CD4. HuMax-CD4 is an investigational drug directed against this receptor. There is no placebo in this trial; all patients will be treated with HuMax-CD4. The response rates, duration of responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated during this trial.

Condition	Intervention	Phase
Cutaneous T-Cell Lymphoma	Drug: HuMax-CD4	Phase II

MedlinePlus related topics:

Cancer Lymphoma

Drug Information available for:

Zanolimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

Medical diagnosis of CTCL, and positivity for the CD4 receptor.
Late stage CTCL.
Have received at least one prior anti-cancer therapy with inadequate effect.
WHO performance status 0,1 or 2
Male or female, age 18 or older.
Signed informed consent.

Exclusion Criteria

Certain rare types of CTCL.
Previous treatment with other anti-CD4 medications.
More than two previous treatments with systemic chemotherapy.
Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial.
Some types of steroid treatments less than two weeks before entering the trial.
Prolonged exposure to sunlight or UV light during the trial.
Other cancer diseases, except certain skin cancers or cervix cancer.
Chronic infectious disease requiring medication.
Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases.
Certain laboratory values which are too high or too low.
HIV positivity.
Pregnant or breast-feeding women.
Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial.
If you are participating in another trial with a different new drug 4 weeks before you enter this trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071084

Locations


United States, California
	Stanford University Med Ctr., Dept of Dermatology
	Stanford, California, United States, 94305-5152

United States, Texas
	University of Texas, M.D. Anderson Cancer Center
	Houston, Texas, United States, 77030-4009

Germany

	MÜNSTER, Germany

Sweden

	Stockholm, Sweden

United Kingdom

	London, United Kingdom

Sponsors and Collaborators

Genmab

More Information

Study ID Numbers:	Hx-CD4-008
First Received:	October 10, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00071084
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genmab:

Skin cancer

Lymphoma

Mycosis fungoides

Sezary syndrome

Study placed in the following topic categories:

Sezary syndrome

Immunoproliferative Disorders

Cutaneous T-cell lymphoma

Sezary Syndrome

Mycosis Fungoides

Skin Neoplasms

Mycoses

Lymphatic Diseases

Lymphoma, T-Cell

Lymphoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphoma

Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Genmab
Information provided by:	Genmab
ClinicalTrials.gov Identifier:	NCT00071084