A trial looking at MTL-005 for head and neck cancers (MOREX)

Cancer type:

Head and neck cancers
Laryngeal cancer
Mouth (oral) cancer
Nasal and paranasal sinus cancer
Pharyngeal cancer
Salivary gland cancer

Status:

Open

Phase:

Phase 1

This trial is looking at a drug called MTL-005 alongside a combination of chemotherapy and radiotherapy (chemoradiation) for head and neck cancers. This trial has 2 parts. In the 1st part people were having radiotherapy to control their symptoms (palliative radiotherapy). Part 1 has now closed. Part 2 is for people with head and neck cancer whose cancer has spread to surrounding tissue (locally advanced disease).

More about this trial

Doctors may use a combination of chemotherapy and radiotherapy (chemoradiation Open a glossary item) to treat people in this situation.

MTL-005 belongs to a group of drugs called radiosensitising Open a glossary item agents. You have MTL-005 through a small tube into your vein. When it enters the blood stream, it collects mainly at the site of the cancer, as well as the liver and spleen.

MTL-005 is only activated in the areas that are treated with radiotherapy. It increases the effects of radiotherapy in this area. It is not a treatment on its own for cancer. But researchers think that it may help to improve the cancer treatments we already have.

This is the first time that MTL-005 has been used in people.

The aims of this trial are to

  • Find the best and safest dose of MTL-005
  • Learn more about the side effects of MTL-005 when used alongside chemoradiation
  • See what happens to MTL-005 in your body
  • Find out if it improves treatment with chemoradiotherapy

Who can enter

The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you.

You may be able to join the 2nd part of this trial if you are due to have chemoradiotherapy (including cisplatin chemotherapy) and all of the following apply. You

  • Have head and neck cancer that has spread to surrounding tissue (locally advanced) but has not spread to another part of the body
  • Are not able to have surgery to remove your cancer
  • Have a type of cancer called squamous cell cancer Open a glossary item
  • Have satisfactory blood test results
  • Are able to care for yourself, but you may not be able to carry on with your normal activities or do active work (a Karnofsky performance status of more than 70%)
  • Are willing to use reliable contraception during treatment until the last day of radiotherapy, if there is any chance that you or your partner could become pregnant
  • Are at least 18 years of age

You cannot join this trial if any of these apply. You

  • Have already had radiotherapy treatment to your head and neck cancer
  • Have had chemotherapy in the last 4 weeks
  • Have had major surgery in the last 2 weeks
  • Are due to have treatment with a biological therapy called cetuximab
  • Have had any other cancer, unless it has been successfully treated and there has been no recurrence of this cancer in the last 10 years
  • Already have hearing problems that could become worse following treatment with cisplatin
  • Already have problems with numbness and tingling in your hands and feet (peripheral neuropathy) that could become worse following treatment with cisplatin
  • Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
  • Are pregnant or breast feeding

Trial design

This is a phase 1 trial.

This trial has 2 parts. Part 1 has now closed to recruitment.

The researchers need 18 people to join the 2nd part of the trial. In the 2nd part, the first few patients joining will have the lowest dose of MTL-005. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until the doctors find the best dose. This is called a dose escalation study.

You have MTL-005 through a thin tube into a vein using a small machine (called an infusion pump). This may take between 40 minutes to 1 ½ hours, depending on the dose you have. If you have 1 of the higher doses, you have half the dose 1 day and the other half the next day. The dose you have depends on when you join the trial.

You have a blood test and urine test before each dose and at 3 different points during the 4 hours following your treatment. You return to hospital every day for the next 4 days to have further blood and urine tests. You may stay in hospital for these 4 days if your doctor thinks this is a better option for you.

The blood and urine samples are used for routine tests and to find out what happens to MTL-005in the body (pharmacokinetics Open a glossary item).

You start radiotherapy between 3 days and 1 week after your infusion of MTL-005. You have radiotherapy every day, Monday to Friday, for a total of 7 weeks. You have further blood and urine tests on your 1st day of radiotherapy and then 3 weeks and possibly 6 weeks later.

You have cisplatin chemotherapy through a drip into a vein on the first day of radiotherapy and 3 weeks later. You may have another dose of cisplatin after a further 3 weeks if your doctor thinks this is appropriate in your situation.

The trial team will ask you to fill out a questionnaire on 2 separate occasions before you start treatment, then 2 months and 5 months after the end of your radiotherapy. The questionnaire will ask about side effects and how you’ve been feeling.  This is called a quality of life study.

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include

  • Blood tests
  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • Urine test
  • MRI scan or CT scan of your cancer (if you haven’t had one done recently)

Before you start treatment in this trial the doctors need to find out whether your cancer tests positive for HPV (human papilloma virus). If this test has not been done already, you will have a blood test or sample taken of your cancer (biopsy Open a glossary item). The researchers will find it useful to know how many people have HPV and how many don’t. The result of the test won’t affect your taking part.

After your radiotherapy has finished, someone in the trial team will telephone you once a week for 12 weeks. They will ask you how you are and if you are having any side effects.

You go to hospital to see the trial team

  • 3 months
  • 6 months
  • 1 year

after your radiotherapy. The doctor will examine you, ask about any side effects and you have further blood and urine tests. You also have a CT scan or MRI scan. These appointments may be in addition to your routine follow up appointments, but where possible they will be arranged for the same day.

Side effects

As MTL-005 is a new drug, there may be side effects we don’t know about yet. Possible side effects include

  • Weight loss
  • Loss of appetite
  • Red and sore skin at the site where you had MTL-005 into your vein

You will be closely monitored by the trial team and have treatment to reduce your side effects if possible.

MTL-005 may increase the side effects of chemoradiotherapy.

The most common side effects of radiotherapy to the head and neck area include

  • Sore skin in treatment area
  • Sore, painful mouth and throat
  • Dry mouth
  • Loss of taste and appetite
  • Difficulty swallowing
  • Hair loss
  • Feeling or being sick
  • Stiff jaw
  • Bad breath

The most common side effects of cisplatin chemotherapy include

  • Tiredness (fatigue)
  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Feeling or being sick
  • Hearing loss, particularly with high pitched sounds
  • A change to the way your kidneys work. You will have blood tests before and during your treatment to check your kidneys

We have more information about

Location

Glasgow
London
Sheffield

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Stefano Schipani

Supported by

Experimental Cancer Medicine Centre (ECMC)
MorEx Development Partners

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12711

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

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