A trial looking at VEPEMB chemotherapy for patients over 60 years old with Hodgkin's lymphoma (SHIELD study)

Please note this trial is no longer recruiting patients.

This trial is to see if a combination of chemotherapy drugs called VEPEMB works as well as ABVD chemotherapy for Hodgkin’s lymphoma.

One of the most common treatments for Hodgkin's lymphoma is a combination of chemotherapy called ABVD. This is the drugs doxorubicin (Adriamycin), bleomycin, vinblastine and dacarbazine. Because the treatment is very intensive, the side effects are quite severe. Older patients often need to have lower doses of drugs, or sometimes aren’t well enough to have this treatment at all.

Doctors hope a new combination of drugs called VEPEMB will be as good as ABVD but cause fewer side effects. VEPEMB is a combination of the chemotherapy drugs vinblastine, cyclophosphamide, procarbazine, etoposide, mitoxantrone and bleomycin, and the steroid prednisolone. They hope it will be better than ABVD for patients over 60 years old.

The aims of this trial are to find out

More about the side effects of VEPEMB
How good VEPEMB is for patients over 60 years old with Hodgkin’s lymphoma.

Recruitment

Start 01/09/2004

End 30/08/2009

Phase

Phase 2

Who can enter

You can enter this trial if you

Have Hodgkin’s lymphoma
Are over 60 years old and
Have not had treatment for your Hodgkin’s lymphoma yet

You cannot enter this trial if you

Have nodular lymphocyte predominant Hodgkin’s lymphoma (NLPHL)
Have already had treatment for your Hodgkin’s lymphoma
Have any other cancer
Are under 60 years old

Trial design

This is a phase 2 trial. It will recruit 150 patients. All the people taking part will have VEPEMB chemotherapy.

You will have chemotherapy in blocks of 4 weeks. Each 4 week period is one cycle.

On the first day of each cycle you have vinblastine and cyclophosphamide through a drip into a vein. You take procarbazine and prednisolone tablets once a day for 5 days, starting on the same day. You don’t have any treatment in the second week.

On the first day of the third week of each cycle, you have mitoxantrone and bleomycin through a drip into a vein. You take etoposide tablets once a day for 5 days, starting the same day. You don’t have any treatment in the fourth week.

If you have stage 1a or 2a Hodgkin’s lymphoma, you will have 3 cycles of chemotherapy. If you have stage 1b, 2b, 3 or 4 Hodgkin’s lymphoma, you will have 6 cycles of chemotherapy. Some patients will have radiotherapy after chemotherapy. Which area of your body is treated with radiotherapy will depend on where your lymphoma is and what stage it is.

You will fill out a questionnaire before you start treatment, after you finish treatment, and 2 and 5 years later. It will ask you about how you have been feeling and about any side effects you have had. This is called a quality of life questionnaire.

Hospital visits

You will see the doctors and have some tests before you take part in this trial. The tests include

Chest X-ray
CT scan or MRI scan
Blood tests
Bone marrow biopsy
Heart ultrasound (echocardiogram or echo)
Physical examination and assessment
Lung function test (spirometry)

You will have blood tests before each cycle of chemotherapy.

You have blood tests and a CT scan after 3 cycles, 6 cycles (if you have 6) and after you finish radiotherapy.

After your treatment you will see the trial doctors

Every month for 3 months, then
Every 3 months for 6 months, then
Every year after that

Side effects

The most common side effects of the drugs in this trial are

A temporary drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
Hair loss
Feeling sick
Diarrhoea
Sore mouth (mucositis)
Numbness and tingling in hands and feet (peripheral neuropathy), but this is rare

There is more information about the side effects of vinblastine, cyclophosphamide, procarbazine, etoposide, and mitoxantrone, bleomycin on CancerHelp UK.

The side effects of radiotherapy depend on which part of the body is treated. There is more information about radiotherapy for Hodgkin’s lymphoma on CancerHelp UK.