Trial record 4 of 7 for:
Zanolimumab
Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.
This study has been completed.
Sponsor:
Emergent Product Development Seattle LLC
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
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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 May 23, 2013