Zalutumumab in Head and Neck Cancer

Study Overview
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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.

Official Title
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An Open, Single Dose Escalation Study Followed by a Multiple Dose Extension of Anti-EGF Receptor Human Monoclonal Antibody (Zalutumumab) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Drug: Zalutumumab


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zalutumumab 0.15 mg/kg<br> | Drug: Zalutumumab<br>* Weekly infusion<br>* Other names: HuMax-EGFr;|
| Experimental: Zalutumumab 0.5 mg/kg<br> | Drug: Zalutumumab<br>* Weekly infusion<br>* Other names: HuMax-EGFr;|
| Experimental: Zalutumumab 1 mg/kg<br> | Drug: Zalutumumab<br>* Weekly infusion<br>* Other names: HuMax-EGFr;|
| Experimental: Zalutumumab 2 mg/kg<br> | Drug: Zalutumumab<br>* Weekly infusion<br>* Other names: HuMax-EGFr;|
| Experimental: Zalutumumab 4 mg/kg<br> | Drug: Zalutumumab<br>* Weekly infusion<br>* Other names: HuMax-EGFr;|
| Experimental: Zalutumumab 8 mg/kg<br> | Drug: Zalutumumab<br>* Weekly infusion<br>* Other names: HuMax-EGFr;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of participants reporting at least one adverse event. | From study start (Day 0) until follow-up period (up to Day 77) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response (OR), Classification | Best Overall Response is defined as the best response from the start of treatment until disease progression (PD) /recurrence and was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). As per RECIST, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck cancer, squamous cell carcinoma of the head and neck