Trial record 22 of 541 for:    cutaneous [CONDITION] AND "lymphoma "[CONDITION]

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

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. Identifier: NCT00071084
Recruitment Status : Completed
First Posted : October 15, 2003
Last Update Posted : December 7, 2012
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC

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
Cutaneous T-Cell Lymphoma Drug: HuMax-CD4 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2003
Actual Primary Completion Date : June 2004

Arm Intervention/treatment
Experimental: 280 mg and 980 mg Drug: HuMax-CD4

Primary Outcome Measures :
  1. Composite assessment of index lesion activity (CA Score) [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: over 20 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00071084

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
Münster, Germany
Stockholm, Sweden
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Emergent Product Development Seattle LLC

Responsible Party: Emergent Product Development Seattle LLC Identifier: NCT00071084     History of Changes
Other Study ID Numbers: Hx-CD4-008
First Posted: October 15, 2003    Key Record Dates
Last Update Posted: December 7, 2012
Last Verified: November 2012

Keywords provided by Emergent Product Development Seattle LLC:
Skin cancer
Mycosis fungoides
Sezary syndrome

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