Zalutumumab in Head and Neck Cancer

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genmab
• Treatments: Antibodies, Monoclonal; Zalutumumab

Criteria

Inclusion Criteria:

The study population eligible for this study is adult male or female patients of good performance status having a histologically confirmed recurrent or metastatic SCCHN, not amenable to standard curative or palliative therapies.

• Diagnosis of squamous cell carcinoma of the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx or larynx.

• Primary or recurrent disease for which no curative or established palliative treatments are amenable

• WHO performance status of 1 or 2.

Exclusion Criteria:

• Received certain other treatments within 4 weeks prior to administration of study drug

• Previous severe allergic reactions (e.g. angio-edema, severe asthma, or anaphylaxis).

• Skin disease requiring systemic or local corticosteroid therapy.

• Known brain metastasis or leptomeningeal disease.

• Signs or symptoms of acute illness.

• Bacterial, fungal or viral infection.

• Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, myocardial infarction within one year 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.

• Simultaneous participation in any other trial involving investigational drugs or having participated in a trial within 4 weeks prior to start of trial treatment.