A study looking at how zalutumumab works in people with head and neck cancer (GEN211)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Head and neck cancers

Laryngeal cancer

Mouth (oral) cancer

Status:

Closed

Phase:

Phase 1/2

This study aims to find out more about how zalutumumab works in people with head and neck cancer. This study is for people with cancer of the mouth, voice box (larynx) and area that surrounds the voice box (hypopharynx).

Doctors often treat cancer of the mouth, voice box and hypopharynx Open a glossary item with surgery, chemotherapy, radiotherapy, biological therapy or a combination of these. But sadly, there are some people whose cancer may not be cured with these treatments. So doctors are always looking for new treatments that may be helpful.

Researchers think that a new type of biological therapy called zalutumumab may help. Zalutumumab is a type of biological therapy called a monoclonal antibody. We know from laboratory studies Open a glossary item that zalutumumab may stop or slow down the growth of cancer cells.

To find out if zalutumumab can help people with head and neck cancer, doctors need to know how it works in the body.

The aim of this study is to find out how zalutumumab works in the body when given as a single, and multiple doses.

Who can enter

You can enter this trial if you

Have squamous cell cancer of the mouth, oropharynx, voice box (larynx) or hypopharynx that your doctor thinks cannot be cured with standard treatment
Are going to have treatment to control your symptoms (palliative care )
Are well enough to take part in this trial
Have satisfactory blood test results
Are willing to use reliable contraception if there is a chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have had drugs that block cancer growth in the 6 months before starting treatment in this trial
Have had chemotherapy in the 4 weeks before starting treatment in this trial
Have had your cancer completely removed with surgery
Have had more than 50 Gray (Gy) of radiotherapy to your tumour within 4 weeks of starting treatment in this trial – your doctor can advise you about this
Are taking drugs as a part of another clinical trial or have done so within the past 4 weeks
Have any type of infection
Have had a serious heart condition in the last 6 months – your doctor can advise you about this
Are known to be HIV, hepatitis B or hepatitis C positive
Are obese (your body mass index (BMI) is 30 or more)
Have another serious medical condition that could affect you taking part in this trial
Are pregnant or breastfeeding

Trial design

This is a phase 1/2 study. It will recruit 26 people. All the people taking part will have zalutumumab. Depending on when you join the study, you will have 1 of 3 different doses.

You have 4 treatments of zalutumumab. After the first treatment, you have a 2 week break. Then you have it once a week for 3 weeks.

You can continue to have weekly zalutumumab if you and your doctor agree it is helping you or until your cancer starts to grow again.

You have zalutumumab through a drip into a vein (intravenous infusion) over about 1 hour.

Hospital visits

You see the doctor and have some tests before you take part in this trial. These tests include

Physical examination
Blood tests
Urine tests
Heart trace (ECG )

In the 1st week of treatment, you visit the hospital 4 times. The 1st visit is to see the doctor, have zalutumumab and the following tests

Physical examination
Blood tests
Urine test

At this visit you may need to stay overnight in hospital to have blood tests after having zalutumumab. You visit the hospital the next day, 3 days and 5 days after treatment to have blood tests.

In the 2nd week of treatment, you visit the hospital twice to have blood tests.

In the 3rd and 4th week you see the doctor, have zalutumumab and the following tests

Physical examination
Blood tests
Urine test

In the 5th week you visit the hospital 4 times. The 1st visit is to see the doctor, have zalutumumab and the following tests

Physical examination
Blood tests
Urine test

At this visit you may need to stay overnight in hospital to have blood tests after the zalutumumab. You visit the hospital the next day, 3 days and 5 days after treatment to have blood tests.

In the 6th week, you visit the hospital twice to have blood tests. In the 1st visit of this week you see the doctor to have a physical examination.

In the 7th week, you visit the hospital twice to have blood tests.

You see the doctor at week 8 to have the following tests

Physical examination
Blood tests
Urine test

Your doctor will discuss with you about continuing with zalutumumab. If you and your doctor agree it is still helping, you will continue to have zalutumumab and blood tests weekly.

You see the doctor, 4 and 8 weeks after you have finished having zalutumumab for blood tests.

Side effects

All treatments have side effects. Side effects of zalutumumab may include

Diarrhoea
Feeling sick
Tiredness
Fever
A rash, dry or itchy skin
Headache
Swelling around the nails
A change in the normal balance of salts in your blood (electrolytes)

You may have a reaction to zalutumumab with flu like symptoms such as fever, chills, shivering and sweating. It can also affect your blood pressure and cause flushing or shortness of breath.