A study looking at high dose chemotherapy and stem cell transplant for prostate cancer that is not responding to hormone therapy (MEL-CAP)

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

Cancer type:

Prostate cancer

Status:

Closed

Phase:

Phase 2

This study is looking to see how well high dose melphalan chemotherapy and stem cell transplants treat prostate cancer that is not responding to hormone therapy.

More about this trial

If you have prostate cancer, you are likely to have hormone therapy. This treatment usually works well for a few years. But at some stage, prostate cancer often stops responding to this. Doctors call this hormone resistance.

Researchers in this study are looking at using a chemotherapy drug called melphalan to treat men in this situation. We know that melphalan can kill prostate cancer cells. But because it causes a severe drop in blood cells, doctors have not been able to give as big a dose as they would like.

They will get around this problem by boosting the body’s production of stem cells. Stem cells Open a glossary item are cells in the bone marrow that develop into red and white blood cells and platelets. Men taking part will have injections of a growth factor to stimulate their bone marrow and release more stem cells into their blood. The researchers will take and store a pint of this stem cell rich blood from each man before their chemotherapy and then give it back through a drip the following day. They call this a whole blood stem cell transplant. The stem cells should help to replace the blood cells killed off by the melphalan, reducing the risk of severe side effects. So, doctors can give higher doses of melphalan.

The aim of this study is to see how well melphalan and stem cell transplants work in men with hormone resistant prostate cancer.

Who can enter

You may be able to enter this study if

You have prostate cancer
Your cancer is not responding to hormone therapy
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You have satisfactory blood tests
You would be willing to use a reliable form of contraception if there is any chance that your partner could become pregnant
You are at least 18 years old

You cannot enter this study if you have

Had a reaction to the chemotherapy drug melphalan or to a growth factor injection called lenograstim
Had a condition called myelodysplastic syndrome, or a cancer affecting a type of cell in your bone marrow called a myeloid cell, such as chronic myelomonocytic leukaemia (CMML), or acute myeloid leukaemia
Had any other invasive cancer in the last 3 years
A heart condition that would make it unsafe for the team to remove a pint of blood from one of your veins
Taken a trial drug in the last 30 days, or are due to start taking one as part of another clinical trial

Trial design

This study will recruit 39 men. Everyone will have a course of melphalan chemotherapy, the growth factor lenograstim, and a series of whole blood stem cell transplants.

For 3 days before your first cycle of treatment, you have lenograstim as an injection under your skin. Your study nurse will teach you how to do this.

On the first day of your treatment, you have a number of blood tests to

Check your PSA
Look at any prostate cancer cells in your blood
See if the injections have helped you make more stem cells

If the test shows you don’t have enough stem cells, you have another injection of lenograstim and a repeat blood test the next day. If you still haven’t got enough stem cells, you will finish the study at this point. If you do have enough, the team will put a needle into your lower arm and take about a pint of blood.

You then have melphalan chemotherapy, through a drip into a vein, over about 15 minutes. The next day you have your pint of blood back through your drip.

A week later you have lenograstim, once a day for 5 days. This makes up one cycle of treatment. The day after the last dose of lenograstim, you start your second cycle of treatment by giving another pint of blood and having melphalan again.

You have 3 cycles of treatment altogether. In the last cycle, you start lenograstim the day after your stem cell transplant. You may have it for up to 10 days, depending on how quickly your body makes new white blood cells.

You have other blood tests during the treatment to check your blood counts.

When you have finished your course of chemotherapy, you have another PSA blood test. If your PSA is falling you will not have any further medication.

If your PSA starts to rise you will start having your original hormone therapy again. Your own specialist will then decide what to do about any further treatment.

Hospital visits

Before you start the study, you will see the doctor and have some tests. These tests include

Physical examination
Blood tests
Bone scan (this is routine)
CT scan of your chest, tummy and the area between your hips (your pelvis) (this is routine)
Heart trace (ECG )

The study team will ask you to fill out a questionnaire before you start treatment and then about every 2 weeks during the study. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

You come to hospital each day for 3 days before you start your treatment, to have your lenograstim injection. If you learn to do this yourself, you will be able to do them at home.

During each treatment cycle you will come to hospital to

Have your blood tests, give a pint of blood and have melphalan
Have your blood transfusion the next day
Have lenograstim injections (unless you can do these yourself at home)
Have blood tests to check your blood counts

If your blood counts are abnormal in any way you will need to make extra visits so the team can monitor this.

After you finish treatment, if your PSA is falling you see the doctor every month for a year, then every 2 months for a year. If it starts to rise you restart hormone therapy and go back to seeing your own cancer specialist.

Side effects

Lenograstim can cause general aches and pains. Paracetamol usually helps to control this.

Side effects of melphalan include

Tingling where melphalan was injected
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Mouth ulcers
Hair loss
Feeling or being sick
Diarrhoea
Loss of fertility

You can find out more about melphalan in our cancer drugs section.