During a routine scan in June 2013 Alan was found to have non Hodgkin lymphoma. “I enrolled onto a clinical trial. I like the idea so that my experience could help others.”
A trial looking at high dose chemotherapy, radiotherapy and stem cell transplant for people recently diagnosed with primary lymphoma of the brain or spinal cord (IELSG32)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at giving
Doctors often treat CNS lymphoma with chemotherapy followed by radiotherapy to the whole brain. The chemotherapy doctors often use is methotrexate and cytarabine. But they are always looking at new ways to improve treatment.
We know from research that thiotepa and rituximab may also help people with lymphoma. Thiotepa is a chemotherapy drug. The researchers think that combining thiotepa with methotrexate and cytarabine may be better than methotrexate and cytarabine alone.
Rituximab is a biological therapy called a monoclonal antibody. We know from research that rituximab can help people with lymphoma in other parts of the body. The researchers think that adding rituximab to methotrexate and cytarabine may be better for people with CNS lymphoma than methotrexate and cytarabine alone.
After chemotherapy people with CNS lymphoma usually have radiotherapy to the whole brain. The researchers think that chemotherapy followed by a stem cell transplant may be better than radiotherapy. They want to compare them to find out if this is so.
The aim of this trial is to compare
- Methotrexate and cytarabine
- Methotrexate, cytarabine and thiotepa
- Methotrexate, cytarabine, thiotepa and rituximab
To find out which combination is better to treat CNS lymphoma before radiotherapy, and what the side effects of these combinations are.
After chemotherapy, they also want to compare whole brain radiotherapy with chemotherapy and stem cell transplant to find out which is best.
Who can enter
You may be able to enter this trial if you
- Have recently being diagnosed with primary
central nervous system (CNS) lymphomaand you haven’t started treatment apart from steroids
- Have at least 1 area of lymphoma that can be seen on a scan
- Have satisfactory blood test results
- Are willing to use reliable contraception if there is any chance you or your partner could become pregnant
- Are well enough to be out of bed or in a chair for more than half the day (performance status 0, 1, 2 or 3) and are between 18 and 65 years old, OR are well enough to be up and about for at least half the day (performance status 0, 1 or 2) and are between 66 and 70 years old
You cannot enter this trial if you
- Have lymphoma in any other part of your body outside the brain and spinal cord
- Have previously been diagnosed with non Hodgkin lymphoma
- Have heart disease that is not controlled or have had a heart attack in the last 6 months
- Have had another cancer in the last 5 years apart from carcinoma in situ of the cervix that has been removed with surgery, skin cancer (non melanoma) or melanoma skin cancer that is only in the outer layer of the skin
- Are taking experimental drugs as part of another clinical trial
- Are HIV, hepatitis B or hepatitis C positive
- Have had an organ transplant or another treatment that could affect how well your
- Have any other condition that could affect you taking part in this trial
- Are pregnant or breastfeeding
This is a phase 2 trial. It will recruit 200 people from Europe . There are 2 parts to this trial and it is randomised. In both parts you will be put into a group randomly. Neither you nor your doctor can choose which group you are in.
For the first part of the trial, there are 3 treatment groups.
People in group 1 have methotrexate and cytarabine. You have methotrexate and cytarabine through a drip into a vein. You have methotrexate on the first day. It takes just over 3 hours. You have 4 doses of cytarabine, 12 hours apart, on the second and third day. Each dose takes about an hour. You have this treatment repeated every 3 weeks.
People in group 2 have methotrexate, cytarabine and rituximab. You have methotrexate and cytarabine the same as in group 1. You have rituximab through a drip into a vein. You have it 5 days before starting chemotherapy and on the day you start chemotherapy. You have all this treatment repeated every 3 weeks.
People in group 3 have methotrexate, cytarabine, rituximab and thiotepa. You have methotrexate, cytarabine and rituximab the same as in group 2. You also have thiotepa through a drip into a vein on the 4th day of chemotherapy. It takes 30 minutes. You have all this treatment repeated every 3 weeks.
Each 3 week period is called a cycle of treatment. Everyone has 4 cycles of treatment.
About 10 days after the 2nd treatment cycle the doctor will check your
For the second part of the trial, your doctor will see how well your 4 cycles of treatment have worked. As long as your lymphoma has not continued to grow, you will be put into one of these groups at random
If your lymphoma has not responded to treatment and has continued to grow, you will have the standard treatment of whole brain radiotherapy.
You have radiotherapy for 4 to 6 weeks (Monday to Friday). During treatment you wear a mask that covers your whole face. This is sometimes also called a radiotherapy mould. The mask is made to measure and fits exactly over your face. This is to keep your head as still as possible during treatment. Some people may feel claustrophobic. But you only have it on for a few minutes at a time and most people get used to it.
You see the doctor and have some tests before taking part in this trial.
These tests include
- A physical examination
- Blood tests
- MRI scan of the brain
- Bone marrow test
- CT scan
- Eye examination
- Lumbar puncture
- PET scan
During treatment you see the doctor at the beginning of each cycle and have the following tests
- A physical examination
- Blood tests
- MRI scan of the brain
After treatment you see the doctor every 3 months and have the same test with a CT scan every year for 10 years.
If your lymphoma comes back you see the doctor and have some further tests.
The most common side effects of methotrexate, cytarabine, and thiotepa include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick
- Sore mouth
- Red, sore or itchy eyes
- Changes to the way your liver works
- Changes to the way your heart works
- Changes to the way your kidneys work
The most common side effects of rituximab include
- Aching muscles and joints
- Red, itchy skin
- Feeling sick
- Low blood pressure
The most common side effects of radiotherapy include
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 Kate Cwynarski
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
International Extranodal Lymphoma Study Group (IELSG)
NIHR Clinical Research Network: Cancer
University Hospital Southampton NHS Foundation Trust
University of Southampton Clinical Trials Unit
This is Cancer Research UK trial number CRUK/10/023.