Clinical Trial of HuMax-CD4, a New Drug to Treat Advanced Stage T-Cell Lymphoma in the Skin.
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 280 mg and 980 mg
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Drug: HuMax-CD4
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Outcome Measures
Primary Outcome Measures
- Composite assessment of index lesion activity (CA Score) [20 weeks]
Secondary Outcome Measures
- Safety [over 20 weeks]
Eligibility Criteria
Criteria
Inclusion criteria
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Medical diagnosis of CTCL, and positivity for the CD4 receptor.
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Late stage CTCL.
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Have received at least one prior anti-cancer therapy with inadequate effect.
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WHO performance status 0,1 or 2
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Male or female, age 18 or older.
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Signed informed consent.
Exclusion Criteria
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Certain rare types of CTCL.
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Previous treatment with other anti-CD4 medications.
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More than two previous treatments with systemic chemotherapy.
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Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial.
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Some types of steroid treatments less than two weeks before entering the trial.
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Prolonged exposure to sunlight or UV light during the trial.
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Other cancer diseases, except certain skin cancers or cervix cancer.
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Chronic infectious disease requiring medication.
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Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases.
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Certain laboratory values which are too high or too low.
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HIV positivity.
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Pregnant or breast-feeding women.
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Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial.
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If you are participating in another trial with a different new drug 4 weeks before you enter this trial.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Stanford University Med Ctr., Dept of Dermatology | Stanford | California | United States | 94305-5152 |
2 | University of Texas, M.D. Anderson Cancer Center | Houston | Texas | United States | 77030-4009 |
3 | Münster | Germany | |||
4 | Stockholm | Sweden | |||
5 | London | United Kingdom |
Sponsors and Collaborators
- Emergent Product Development Seattle LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Hx-CD4-008