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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.
First Received: October 10, 2003   Last Updated: June 23, 2005   History of Changes
Sponsored by: Genmab
Information provided by: Genmab
ClinicalTrials.gov Identifier: NCT00071084
  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

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

Resource links provided by NLM:

  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

No publications provided

Study ID Numbers: Hx-CD4-008
Study First Received: October 10, 2003
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00071084     History of Changes
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:
Lymphatic Diseases
Mycoses
Immunoproliferative Disorders
Cutaneous T-cell Lymphoma
Lymphoma, T-Cell
Sezary Syndrome
Mycosis Fungoides
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Skin Neoplasms
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoma, T-Cell
Sezary Syndrome
Mycosis Fungoides
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on September 03, 2009