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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Emergent Product Development Seattle LLC

ClinicalTrials.gov Identifier:

NCT00071084

First received: October 10, 2003

Last updated: December 5, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 10, 2003
Last Updated Date	December 5, 2012
Start Date ^ICMJE	May 2003
Primary Completion Date	June 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 5, 2012)	Composite assessment of index lesion activity (CA Score) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00071084 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 5, 2012)	Safety [ Time Frame: over 20 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Trial of HuMax-CD4, a New Drug to Treat Advanced Stage T-Cell Lymphoma in the Skin.
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cutaneous T-Cell Lymphoma
Intervention ^ICMJE	Drug: HuMax-CD4
Study Arm (s)	Experimental: 280 mg and 980 mg Intervention: Drug: HuMax-CD4
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	22
Completion Date	Not Provided
Primary Completion Date	June 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Germany, Sweden, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00071084
Other Study ID Numbers ^ICMJE	Hx-CD4-008
Has Data Monitoring Committee	Not Provided
Responsible Party	Emergent Product Development Seattle LLC
Study Sponsor ^ICMJE	Emergent Product Development Seattle LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Emergent Product Development Seattle LLC
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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