A trial of mifamurtide for advanced osteosarcoma (MEMOS)

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

Cancer type:

Bone cancer

Sarcoma

Status:

Closed

Phase:

Phase 2

This trial is looking at a drug called mifamurtide for a type of bone cancer called osteosarcoma. It is for people who have osteosarcoma that has come back after treatment and cannot be completely removed with surgery (advanced osteosarcoma).

More about this trial

If you have advanced osteosarcoma, you may be able to have surgery to remove as much of the sarcoma as possible. You may also have chemotherapy. But researchers want to find other ways of helping people in this situation.

They are looking at a drug called mifamurtide which boosts the immune system and helps to kill cancer cells. Doctors can already use mifamurtide alongside chemotherapy for people who have had surgery to completely remove their osteosarcoma. It can lower the risk of the sarcoma coming back, but not everyone benefits from the drug.

In this trial, researchers want to see if mifamurtide can help people with advanced osteosarcoma. They want to understand why the drug works against some cancers, but doesn’t help everybody.

Who can enter

You may be able to join this trial if all of the following apply. You

Have osteosarcoma that has come back after treatment and a scan done in the last 6 months shows that it is getting worse
Have fully recovered from the side effects of any earlier treatment
Have had a CT scan in the last 3 weeks which shows at least one area of osteosarcoma that can be measured
Have an area of sarcoma that can be removed with surgery, or can be reached to take a biopsy from
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have satisfactory results of blood tests and tests to check how well your heart is working
Are at least 16, but no older than 65
Are willing to use reliable contraception during the trial and for at least 1 week after your last dose of the trial drug if there is any chance you or your partner could become pregnant

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

Have cancer that has spread to your brain
Have had mifamurtide (or a similar drug such as GCSF or interferon) as part of a clinical trial for advanced sarcoma in the last 6 months or outside of a clinical trial in the last 6 weeks
Have taken part in any other clinical trial in the last 3 weeks
Have major surgery in the 3 weeks before the first biopsy you have as part of this trial
Can’t have a biopsy taken from your lungs for any reason
Are known to be very sensitive to ifosfamide or mifamurtide or anything it contains
Have had a heart attack in the last 6 months or have certain other heart problems (the trial team can advise you about this)
Are currently taking steroids or painkillers called non steroidal anti inflammatory drugs (NSAIDs)
Take a drug called ciclosporin (or a similar drug)
Have any other cancer apart from carcinoma in situ of the cervix or non melanoma skin cancer
Have any other medical condition or mental health problem that the trial team think could affect your taking part
Are known to be HIV, hepatitis B or hepatitis C positive
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The researchers need 40 people to join. There are 3 different treatment groups.

Everybody taking part will have mifamurtide for 36 weeks (about 9 months). Depending on which group you are in, you also have either surgery or a chemotherapy drug called ifosfamide.

Whichever group you are in, you have mifamurtide through a drip into a vein. It takes about an hour each time.

If, when you join the trial, your doctors think you can have surgery, you join group A. You have a biopsy Open a glossary item or surgery to remove osteosarcoma that has spread (a metastasectomy), followed by 6 weeks of mifamurtide. You then have more surgery, either to remove osteosarcoma from where it started (a resection) or a metastasectomy. After recovering from the operation, you have another 30 weeks of mifamurtide.

MEMOS trial diagram 1

You have mifamurtide twice a week for the first 6 weeks of treatment. After the 2nd operation, you have it twice a week for 6 weeks, then once a week for the next 24 weeks.

If, when you join the trial, your doctors don’t think surgery would be possible, you have a biopsy and are then put into either group B or group C by computer. Neither you nor the trial team can decide which of these 2 groups you are in. This is called randomisation.

If you are in group B, you have ifosfamide for 6 weeks, followed by another biopsy or surgery (if this is possible after chemotherapy). You then have mifamurtide alongside ifosfamide for 6 weeks, followed by 30 weeks of mifamurtide alone.

If you join group C, you have mifamurtide alongside ifosfamide for 6 weeks, followed by another biopsy or surgery (if possible). You then have mifamurtide and ifosfamide for 6 weeks, followed by 24 weeks of mifamurtide alone.

MEMOS trial diagram 2

You have ifosfamide through a drip into a vein for 4 to 5 days, once every 3 weeks. Each 3 week period is called a cycle of treatment. You have 4 cycles of ifosfamide in total - 2 cycles before your 2nd biopsy (or surgery) and 2 cycles afterwards.

When you have mifamurtide alongside ifosfamide, you have it twice a week. After that, you have it once a week.

Whichever group you are in, the trial team will test samples of your sarcoma they take during biopsies or surgery before and after the first 6 weeks of mifamurtide treatment. They will measure substances called biomarkers Open a glossary item that show how mifamurtide has affected the osteosarcoma cells.

Hospital visits

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

Physical examination
Blood tests
CT scan or MRI scan
Heart scan (echocardiogram )
Heart trace (ECG )

If you are joining group B or group C, you will also have a test to see who well your kidneys are working (GFR test Open a glossary item ).

People in group A go to hospital twice a week during the first 12 weeks of mifamurtide. They then go once a week for the next 24 weeks.

People in group B go to hospital to have ifosfamide twice in the first 6 weeks. When they start having mifamurtide alongside ifosfamide after the 2nd biopsy (or surgery), they go to hospital twice a week for the first 12 weeks and then once a week for the next 24 weeks.

People in group C go to hospital twice a week in the first 6 weeks. When they start treatment again after the 2nd biopsy (or surgery), they go twice a week for 6 weeks and then once a week for the next 24 weeks.

Whichever group you are in, you see the trial team and have blood tests regularly throughout treatment. You have CT scans after having mifamurtide for 6, 12, 18, 24 weeks.

When you finish treatment, you see the trial team again and have another CT scan between 2 and 4 weeks later.

Side effects

As mifamurtide is still quite a new drug, there may be side effects we don’t know about yet. So far, the most common side effects include

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Tiredness (fatigue)
Feeling or being sick
Loss of appetite
Headache and dizziness
Sweating
A faster heart beat
An increase or decrease in your blood pressure
Cough
Flu like symptoms
Constipation
Diarrhoea
Loss of fertility

Many of the side effects of ifosfamide are similar to those of mifamurtide. Other common side effects include

Hair loss
Irritation of the bladder and kidneys

When you have ifosfamide, you also have a drug called mesna through a drip into a vein. It protects the lining of your bladder from irritation and bleeding that ifosfamide can cause.

The risks of having surgery or a biopsy vary depending on where in your body the sarcoma is. The trial team will explain this to you. The main side effects are pain and risk of bleeding.