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Clinical Trial of HuMax-CD4, a new drug to treat Advanced Stage T-Cell Lymphoma in the skin.



Clinical Trial of HuMax-CD4, a new drug to treat Advanced Stage T-Cell Lymphoma in the skin.

For Condition: Cutaneous T-Cell Lymphoma
Status: Recruiting
Sponsor(s): Genmab ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

University of Texas, M.D. Anderson Cancer Center *No longer recruiting*
Houston,  Texas,  77030-4009
United States
No longer recruiting  

Stanford University Med Ctr., Dept of Dermatology *No longer recruiting*
Stanford,  California,  94305-5152
United States
No longer recruiting  


Additional Information:
Study ID Numbers:
  Hx-CD4-008; 
Study Start Date: 
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071084

Other Cutaneous T-Cell Lymphoma Studies:
1. Pegfilgrastim Compared With Filgrastim To Increase Peripheral Stem Cells Before Autologous Stem Cell Transplantation in Treating Patients With Lymphoma

2. Characterizing Serum Protein Patterns in Selected Skin Diseases

3. FR901228 in Treating Patients With T-Cell Lymphoma

4. Gemcitabine, Carboplatin, and Dexamethasone With or Without Rituximab in Treating Patients With Relapsed or Primary Refractory Lymphoma

5. Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides

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Clinical Trial of HuMax-CD4, a new drug to treat Advanced Stage T-Cell Lymphoma in the skin.

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