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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00071084
First Posted: October 15, 2003
Last Update Posted: December 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC
October 10, 2003
October 15, 2003
December 7, 2012
May 2003
June 2004   (Final data collection date for primary outcome measure)
Composite assessment of index lesion activity (CA Score) [ Time Frame: 20 weeks ]
Not Provided
Complete list of historical versions of study NCT00071084 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: over 20 weeks ]
Not Provided
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Clinical Trial of HuMax-CD4, a New Drug to Treat Advanced Stage T-Cell Lymphoma in the Skin.
Not Provided
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cutaneous T-Cell Lymphoma
Drug: HuMax-CD4
Experimental: 280 mg and 980 mg
Intervention: Drug: HuMax-CD4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
Not Provided
June 2004   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Sweden,   United Kingdom,   United States
 
 
NCT00071084
Hx-CD4-008
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Emergent Product Development Seattle LLC
Emergent Product Development Seattle LLC
Not Provided
Not Provided
Emergent Product Development Seattle LLC
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP