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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier:
NCT00071071
First received: October 10, 2003
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

The purpose of this trial is to determine the effect of HuMax-CD4 as a treatment for early stage cutaneous T-cell lymphoma (CTCL). Almost all patients who are affected by CTCL have 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. During the trial, the response rates, duration of responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Emergent Product Development Seattle LLC:

Primary Outcome Measures:
  • Composite Assessment of Index Lesion Disease Activity (CA Score) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: over 20 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: April 2003
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 280 mg and 560 mg Drug: HuMax-CD4

  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.
  • Early stage CTCL
  • Have received at least two prior therapies with inadequate effect, including phototherapy and/or electron beam, and/or chemotherapy.
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071071

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
Sponsors and Collaborators
Emergent Product Development Seattle LLC
  More Information

No publications provided

Responsible Party: Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier: NCT00071071     History of Changes
Other Study ID Numbers: Hx-CD4-007
Study First Received: October 10, 2003
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 22, 2014