Zalutumumab in Head and Neck Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-01

Study Completion Date

2005-01-12

Brief Summary

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

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Detailed Description

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Conditions

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Head and Neck Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Weekly infusion

Intervention Type DRUG

Other Intervention Names

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HuMax-EGFr

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No