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

Sponsor

Emergent Product Development Seattle LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00071071

Collaborator

(none)

Enrollment

Locations

Arm

12.5

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cutaneous T-Cell Lymphoma	Drug: HuMax-CD4	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

May 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 280 mg and 560 mg	Drug: HuMax-CD4

Arm

Intervention/Treatment

Experimental: 280 mg and 560 mg

Drug: HuMax-CD4

Outcome Measures

Primary Outcome Measures

Composite Assessment of Index Lesion Disease Activity (CA Score) [20 weeks]

Secondary Outcome Measures

Safety [over 20 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Med. Ctr., Dept. of Dermatology	Stanford	California	United States	94305-5152
2	University of Texas, M.D. Anderson Cancer Center	Houston	Texas	United States	77030-4009