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
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 April 14, 2014