A study looking at a new way to give melphalan chemotherapy for prostate cancer that can no longer be treated with hormone therapy (PR-2006-03)

Please note this trial is no longer recruiting patients.

This study is using stem cells to boost the immune system, allowing doctors to give melphalan (Alkeran) chemotherapy twice as often for prostate cancer.

Doctors often use hormone therapy to treat prostate cancer. This treatment usually works well for a few years. But the cancers often become resistant to hormone therapy at some stage. Doctors may then use other treatments, such as chemotherapy.

Doctors have used melphalan to treat prostate cancer, but it causes a drop in blood cells, limiting the dose you can have. In this study you will have your own stem cells through a drip after chemotherapy. This should help your blood cell counts to recover more quickly. So doctors should be able to safely give the melphalan twice as often as before. They also want to see if hormone therapy will start to work again after having melphalan. The aims of this study are to

See how well intensive melphalan followed by stem cells works for hormone resistant prostate cancer
Understand more about any side effects
Study prostate cancer cells from blood samples to understand what makes them become sensitive to hormone therapy again

Recruitment

Start 01/09/2006

End 04/11/2011

Phase

Phase 2

Who can enter

You can enter this study if you

Have prostate cancer
Have been taking hormone therapy to treat your prostate cancer, but this is no longer working (your cancer is ‘hormone resistant’)
Have satisfactory blood tests
Are well enough to take part (performance status 0, 1 or 2)
Are at least 18 years of age

You cannot enter this study if you

Have had any other cancer apart from basal cell carcinoma
Have a condition where your heart can’t pump blood quickly enough (heart failure)
Have severe uncontrolled chest pain (unstable angina)
Have high blood pressure that can’t be controlled with medication
Are having treatment in another clinical trial

Trial design

This study will recruit 18 people. Everyone will have a course of treatment with melphalan followed by an infusion of their own stem cells in a pint of their blood.

To make sure you have enough stem cells, you start a course of 3 injections under your skin 3 days before your chemotherapy. These injections are called growth factors, and help your body to produce more stem cells. The day after the 3rd injection, you have a blood test. If this sample contains enough stem cells, you then give about a pint of blood (in the same way as a blood donor would). This blood will be stored in a fridge for 24 hours. At the same time you will give 3 more small samples of blood for the study.

You then have your melphalan chemotherapy. You have melphalan through a drip into a vein, over about 15 minutes. The first few men taking part will have the lowest dose of melphalan. If they don’t have any serious side effects, the next few will have a higher dose. And so on, until they find the best dose to give. This is called ‘dose escalation’.

The following day you have a blood transfusion through a drip into a vein, using the pint of blood you gave the day before.

You repeat this every 2 weeks, but will now have growth factor injections for 5 days before your treatment instead of 3. The research team will teach you or a carer how to do these injections. You have 4 cycles of treatment altogether.

After this, you have a PSA blood test. If your PSA reading is falling, you will not have any more treatment, but will visit the outpatient clinic every 4 weeks. If your reading starts to rise you will start taking hormone therapy again. If this does not work, the doctor will give you the steroid dexamethasone, with the hormone diethylstilbestrol. You stay on these drugs until your cancer is no longer responding to them. You then finish the study, and continue to see your specialist cancer doctors in the same way as you did before.

Hospital visits

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

Bone scan (within 3 months of starting the study)
CT scan of your tummy area (abdomen) and the area between your hips (your pelvis)
Chest X-ray
Heart trace (ECG)
Blood tests

You complete a questionnaire before the study, before each cycle of treatment and then within a month of finishing your treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

Before each cycle of treatment, you collect your next course of growth factor injections, to give yourself at home.

Everyone will have to come to the hospital to have melphalan chemotherapy and blood transfusion the following day. If you are one of the first 3 patients in this study, you stay in hospital for 24 hours after each melphalan treatment. Everyone after this will have the study treatment as an outpatient. So they will have to come to the hospital 2 days running, first for chemotherapy and the following day for their blood transfusion.

Within a month of finishing your treatment, you see the doctor and may repeat some of the tests you had before the study.

After this you see the doctor monthly, have a blood test and any scan you may need. The study visits finish when you are no longer having active treatment as part of this trial. You then see your specialist in the same way as you did before.

Side effects

Common side effects of the growth factor (lenograstim) include aches and pains. Taking paracetamol may help.

Common side effects of melphalan include

A drop in blood cells causing an increased risk of infection, bruising or bleeding problems, tiredness and breathlessness
Tiredness (fatigue)
Feeling or being sick
Diarrhoea
A sore mouth