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A trial of siltuximab for multicentric Castleman's disease
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at siltuximab (also known as CNTO 328) for a condition called multicentric Castleman’s disease.
In Castleman’s disease, tumours grow in the
MCD is not cancer, but it can develop into non Hodgkin lymphoma. Treatment for MCD aims to control symptoms, but doctors are not sure of the best way to treat the disease and currently there is no
This trial is looking at a drug called siltuximab. Siltuximab is a type of biological therapy called a monoclonal antibody. It blocks a protein called interleukin 6 (IL-6) that is found naturally in the body. Researchers think that blocking the action of IL-6 may help to treat Castleman’s disease.
Everybody taking part in the trial will have treatment to help with any symptoms they have. This is called best supportive care. Some people will also have siltuximab.
The aims of the study are to
- See if siltuximab and best supportive care is better for people with multicentric Castleman’s disease than best supportive care alone
- Learn more about the side effects
Who can enter
You can enter this trial if you
- Have been diagnosed with multicentric Castleman’s disease and it is causing symptoms
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood test results
- Are willing to use reliable contraception during the trial if there is any chance you could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have multicentric Castleman’s disease, but the only areas that can be measured are on your skin
- Have other conditions associated with Castleman’s disease called paraneoplastic pemphigus or bronchiolitis obliterans which can affect your skin, mouth and lungs
- Are taking steroids (unless it is a low dose that has not been increased in the last 4 weeks)
- Are having other treatment to shrink your MCD tumours, including other types of biological therapy, chemotherapy or drugs that damp down your
- Have had another experimental drug for MCD in the last 4 weeks (8 weeks if you had a drug called rituximab)
- Have already had drugs that target IL-6
- Have had surgery in the last 4 weeks
- Have had lymphoma
- Have had any other type of cancer apart from non melanoma skin cancer or cervical cancer in situ that have been successfully treated, or another cancer if you have been completely free of the disease for at least 3 years
- Have had a heart attack or heart pain (angina) in the last year, or you have any other heart problem that is a cause for concern
- Have an infection, including hepatitis C, or any other medical condition that could affect you taking part in this trial
- Have tested positive for hepatitis B, HIV or a virus called HHV-8
- Have had a live vaccine in the last 4 weeks
- Are known to be sensitive to monoclonal antibodies or anything used to make them
- Are pregnant or breastfeeding
This trial will recruit about 78 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.
People in one group have best supportive care and siltuximab. People in the other group have best supportive care and a dummy drug (
You have siltuximab (or the dummy drug) through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment.
As long as it is helping and you don’t have any bad side effects, you can carry on having the trial treatment until 48 weeks after the last person joins the trial.
If your symptoms are getting worse and you want to continue in the study, your doctor may be able to find out which group you are in. If you are in the group having the dummy drug, you will be able to switch over to the other group and start having siltuximab. If you are in the siltuximab group, you will leave the trial and your doctor will talk to you about other possible treatments. But if you have already decided you don’t want to have any more treatment, your doctor will not find out which group you are in until everybody else taking part in the trial has finished treatment.
You will be asked to fill out some questionnaires before you start treatment and then a number of times during the trial. The questionnaires will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Blood and urine tests
- Heart trace (
- CT scan
- A photograph of your skin (if any of your skin is affected by MCD)
The researchers need a sample of tissue to confirm that you have MCD. They will try to get a sample that was taken when you were diagnosed. But if there is not a sample available, you will need to have a lymph node biopsy.
You go to hospital 3 times in the first cycle of treatment and once in each treatment cycle after that. You have an ECG in cycle 4 and then every 6 months for as long as you have treatment. You have a CT scan and skin photography (if appropriate) every 3 months for up to 2 years, then once every 6 months until you finish treatment.
When you do finish treatment, you go back to see the trial team and have blood tests 1, 2, 4, 8 and 12 weeks later. After about a month, you have some other tests including a CT scan, ECG and skin photography.
If there are no signs of your disease getting worse when you stop treatment, you will be asked to go back and have these tests every 3 months until the end of the study.
After finishing treatment, a member of the trial team will contact you every 6 months to see how you are.
As siltuximab is a new drug, there may be side effects we don’t know about yet. From earlier trials, the researchers know that side effects can include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- An increase in the amount of cholesterol in your blood
- Feeling or being sick
- Tiredness (fatigue)
- Weakness and dizziness
- Headache or pain in other parts of your body
- Diarrhoea or constipation
- Cough or shortness of breath
A few patients have had an allergic reaction to siltuximab. The study team will watch you very closely during the treatment. If you have a reaction, they can slow down or stop the drip and treat any symptoms straight away.
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.
Dr S Schey
Experimental Cancer Medicine Centre (ECMC)
Janssen Biologics B.V.