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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emergent Product Development Seattle LLC
• Treatments: Zanolimumab

Criteria

Inclusion criteria

• Medical diagnosis of CTCL, and positivity for the CD4 receptor.

• Late stage CTCL.

• Have received at least one prior anti-cancer therapy with inadequate effect.

• WHO performance status 0,1 or 2

• 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.