A trial looking at PUVA with or without bexarotene for people with Mycosis Fungoides (EORTC 21011)

Please note this trial is no longer recruiting patients.

This trial is comparing PUVA alone with PUVA and bexarotene (Targretin) for Mycosis Fungoides T cell lymphoma of the skin.

Mycosis fungoides is a rare type of non Hodgkin’s lymphoma that affects the skin. It belongs to a group of conditions called cutaneous T cell lymphoma. Cutaneous T cell lymphomas are cancers of a type of white blood cell, called T lymphocytes.

If you have early stage mycosis fungoides, you may have a treatment called PUVA. Although this treatment works well at first, the cancer usually comes back (recurs) and then you need more treatments with PUVA. If you have repeated courses of PUVA, your risk of developing non melanoma skin cancer increases. Doctors would like to be able to reduce the dose of PUVA and so reduce this risk.

This trial will look at a drug called bexarotene. This is a new type of ‘retinoid’ drug. Retinoids contain chemicals that are similar to vitamin A. The researchers will compare PUVA with a combination of bexarotene and PUVA. They will try to find out

Whether PUVA with bexarotene is more effective than PUVA alone
Which treatment has the fewest side effects
Whether the combination of bexarotene and PUVA means that the dose of PUVA can be reduced

Recruitment

Start 20/01/2003

End 31/05/2010

Phase

Phase 3

Who can enter

You can enter this trial if you

Have mycosis fungoides that is stage 1B or 2A disease. Stage 1B and 2A means that you have patches or plaques of mycosis fungoides on your skin and your lymph nodes are enlarged but there is no sign of cancer inside them
Have satisfactory blood results
Are at least 18 years of age
Are willing to use reliable contraception if there is a chance that you or your partner could become pregnant
Are willing to limit your exposure to the sun on the day of your PUVA and are willing to keep out of the sun while taking part in this trial

You cannot enter this trial if you

Have any medical condition that means you cannot have the treatment in this trial
Have had a combination of chemotherapy drugs as tablets or injections - you may be able to take part if you are have used chemotherapy cream (topical chemotherapy) in the past
Have had cancer before (apart from non melanoma skin cancer or carcinoma in situ of the cervix which have been treated)
Have had Total Skin Electron Beam Therapy in the last 6 months
Have had topical chemotherapy, photopheresis or interferon in the last 3 months
Have had topical drugs (such as corticosteroids or tar baths), UVB phototherapy, PUVA or superficial radiotherapy in the last month
Have had treatment with other retinoid type or beta carotene drugs in the last month
Have had PUVA treatment in the past and either it didn’t work or you had severe side effects as a result
Have taken part in another clinical trial in the last 30 days

Trial design

This European trial aims to recruit about 134 patients. There are two treatment groups in this trial. The trial is randomised. The people taking part are put into the different treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have PUVA on its own. If you are in group 2, you will have PUVA and bexarotene.

Both groups will have PUVA 3 times a week for about 4 months. About 2 hours before each treatment, you will have a tablet called psoralen, which makes your skin very sensitive to ultraviolet light.

You will then stand in a cubicle (which is taller and wider than you) to have the ultraviolet light therapy. This is sometimes called a ‘light box’. You will be asked to remove your clothing and wear protective glasses. The doctor or nurse carrying out the treatment will tell you what you need to do. This treatment will take about 10 minutes.

If you are in group 2, you will also have bexarotene tablets every day for about 4 months. You will need to take these tablets with food or just after eating food.

Hospital visits

Before you start your treatment a doctor will examine you and you will have various tests. These tests may include

Blood tests
X-rays and ultrasound scans of your cancer

Some of these tests may be repeated during the 3 months of your treatment. When your treatment has finished you will see the doctor every 2 months to find out how you are getting on and whether your treatment has worked.

If the mycosis fungoides comes back, your doctor will discuss other treatment options with you.

Side effects

All treatments have side effects. The most common side effects of PUVA include

Feeling or being sick
Redness and itching of the skin
Dryness and blistering of the skin

PUVA makes you more sensitive to sunlight, so you will need to limit your exposure to the sun on the day of your treatment. You will have specific instructions about this to take home.

The most common side effects of bexarotene include

Dry, sensitive skin
Tiredness and lack of energy
Headaches
Feeling or being sick
Loss of appetite
Diarrhoea
Temporary hair loss
Sore cracked lips

Combining PUVA with bexarotene is a new treatment. So doctors are not sure whether this combination will cause extra side effects. Your doctor will see you 3 times a week during your treatment and they will ask you to report any side effects.

Whichever group you are in, your doctor will keep a close eye on you and try to prevent or treat any side effects.