A trial looking at chemotherapy for people with advanced T cell lymphoma of the skin (EORTC 21012)

Please note this trial is no longer recruiting patients.

This trial is looking at liposomal doxorubicin chemotherapy for people with an advanced T cell lymphoma of the skin called mycosis fungoides.

Cutaneous T cell lymphomas (CTCL) are types of non Hodgkin’s lymphoma that affect the skin. Mycosis fungoides is the most common of these, although it is still rare. Doctors usually treat CTCL with chemotherapy applied to the skin (topical chemotherapy), light treatment (PUVA), radiotherapy or immunotherapy. If the treatment stops working or your cancer becomes more advanced, then doctors can use chemotherapy injected into the bloodstream to treat your CTCL.

Doctors usually use a combination of chemotherapy drugs for advanced CTCL. But these treatments can have severe side effects. Doctors think that liposomal doxorubicin (Caelyx, Myocet or Doxil) may work as well on its own and have fewer side effects. But they are not sure yet.

The aims of this trial are to find out

How well liposomal doxorubicin works for mycosis fungoides CTCL
More about the side effects

Recruitment

Start 22/10/2003

End 03/07/2009

Phase

Phase 2

Who can enter

You can enter this trial if

You have stage 2b, 4a or 4b mycosis fungoides
Your lymphoma has come back or stopped responding after at least 2 or more different treatments
You have satisfactory blood test results
You are well enough for treatment (Karnofsy performance status of 60 or more)
You are at least 18 years old
You are willing to use reliable contraception if there is any chance that you or your partner could become pregnant

You cannot enter this trial if you

Have any other stage of mycosis fungoides or another type of cutaneous T cell lymphoma
Have lymphoma in your brain or spinal cord (central nervous system)
Are having steroid treatment unless it is applied directly to the skin (topical)
Are allergic to anthracycline chemotherapy such as doxorubicin
Have had chemotherapy, immunotherapy or radiotherapy in the last 2 weeks
Have had high doses of anthracycline chemotherapy in the past - your doctor can tell you more about this
Have had high dose methotrexate chemotherapy in the past - you can check this with your doctor
Are still having side effects from cancer treatment you had in the past, apart from hair loss
Have a serious heart problem
Are having treatment for an infection
Have had another cancer in the past apart from non melanoma skin cancer or carcinoma in situ of the cervix that was successfully treated
Are known to have HIV

Trial design

This is a phase 2 trial and will recruit 48 people.

Everyone will have liposomal doxorubicin as a drip into a vein and this takes about an hour. You have this every 2 weeks for up to 6 cycles of treatment. Each 4 week period is a cycle of treatment.

Every 8 weeks you have some tests to see how well the treatment is working. If the tests show the treatment is not helping you, the doctor will probably stop treatment. They will then discuss other treatment options with you. If the treatment is working, you will continue with treatment.

The researchers will ask permission to have a sample of your cancer that was taken when you had your skin biopsy. They will use this for future research to help doctors understand which treatments are best for which patients. You don’t have to give this sample if you don’t want to. You can still take part in the trial.

Hospital visits

Before you can start treatment, your doctor will examine you and you will have some tests. The tests include

Blood tests
Chest X-ray
Ultrasound of your stomach and lymph nodes
Skin biopsy
Heart trace (ECG)
Echocardiogram

You go to the hospital outpatient department for treatment. For the first treatment, you need to stay overnight in the hospital. But you won’t need to stay overnight for further treatments.

You have a chest X-ray, an ultrasound and your skin lesions measured every 2 months to see how well the treatment is working.

When you finish treatment, you go to the hospital to see the trial doctor every 3 months for a check up.