Clinical trial NCT00071071: Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.
Official title: An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Refractory or Persistent Early Stage (IA-IIA) Cutaneous T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous T-Cell Lymphoma
Keywords: Skin cancer
Lymphoma
Mycosis fungoides
Sezary syndrome
Lead sponsor: Genmab
Sponsor class: INDUSTRY
First posted: 2003-10-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 participants 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 participants 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.


Eligibility 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.
* Histopathological evidence of large cell transformation or poorly differentiated tumors or prior treatment with anti-CD4 monoclonal antibodies excluded participants from inclusion in the study.

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.
* 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.

Note: Other protocol defined Inclusion and Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: From Baseline (Day 0) up to end of study (Week 20)
measure: Percentage of Participants With Physician's Global Assessment of Clinical Condition (PGA) Response at Weeks 2, 4 and 12
timeFrame: At Weeks 2, 4 and 12
measure: Percentage of Participants With Change from Baseline in Participant's Assessment of Pruritus Scale
timeFrame: Baseline, up to Week 20
measure: Time to Response
timeFrame: From first dose to achieving a response (up to approximately 11 weeks)
measure: Response Duration
timeFrame: From achieving first response to last response/until relapse (up to approximately 92 weeks)
measure: Time to Disease Progression
timeFrame: From first dose until disease progressed (Up to 20 weeks)
measure: Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA)
timeFrame: Baseline up to Week 20
measure: Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
timeFrame: Up to Week 20
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Med. Ctr., Dept. of Dermatology
state: California
city: Houston
country: United States
facility: University of Texas, M.D. Anderson Cancer Center
state: Texas
Study officials:
References: