A trial looking at ABR-217620 in combination with interferon for advanced renal cell cancer

Please note this trial is no longer recruiting patients.

This trial is looking at a new biological therapy called ABR-217620 in combination with interferon to treat advanced renal cell cancer.

Renal cell cancer is the most common type of kidney cancer. Advanced kidney cancer may be treated with biological therapy, chemotherapy, radiotherapy or surgery, or a combination of these.

Interferon is a type of biological therapy and is often used to treat advanced kidney cancer.

ABR-217620 is a new and experimental treatment. It is made of 2 proteins. The first one recognises renal cancer cells. The second one stimulates the immune system to attack the cancer cells. It does this by activating some of the white blood cells called T cells.

The aim of this trial is to see if a combination of ABR-217620 and interferon works better than interferon alone.

Recruitment

Start 11/04/2007

End 19/05/2009

Phase

Phase 3

Who can enter

You can enter this trial if

You have been diagnosed with advanced renal cell cancer
Your doctor thinks that treatment with interferon may help you
You have satisfactory blood test results
You are well enough to take part in the trial
You are prepared to use reliable contraception while you are taking part in the trial if there is any chance you or your partner could become pregnant
You are at least 18 years old

You cannot enter this trial if you

Have cancer that has spread to your brain
Have had radiotherapy or surgery in the last 4 weeks
Have already had immunotherapy or chemotherapy for your renal cell cancer
Have had other types of biological therapy in the last 3 weeks
Have had an experimental treatment in the last 6 weeks as part of another clinical trial
Are having kidney dialysis treatment
Have other medical problems such as an auto immune disease, certain heart conditions, uncontrolled high blood pressure or hepatitis
Have had a heart attack in the last 12 months
Have had a stroke in the last 5 years
Have had steroids in the last 2 weeks (please note, it is important that you do not stop taking steroids unless your doctor tells you to)
Have been having certain types of anti coagulation (blood thinning) treatment in the last 2 weeks
Have had drugs called beta blockers in the last 5 days (you can take part if you use beta blocker eye drops as treatment for glaucoma)
Have had any other cancer in the last five years, apart from non melanoma skin cancer, carcinoma in situ of the cervix, DCIS or LCIS that has been successfully treated
Have an infection or other serious medical condition
Are allergic or sensitive to a group of antibiotics called aminoglycosides
Are known to be HIV positive
Are pregnant or breastfeeding

Trial design

This is an international study. It will recruit 524 people. As this is a randomised trial, you will be put into one of 2 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 interferon and ABR-217620. In the first week of your treatment, you will have ABR-217620 every day for 4 days. Then no treatment for the next 3 days. You will have ABR-217620 as an injection into a vein (intravenous injection).

For the next 7 weeks, you will have interferon 3 times a week. You will have this as an injection, either under the skin (subcutaneous), or into a muscle (intramuscular). This 8 week treatment period is called a cycle. You will have 3 cycles of treatment, lasting about 6 months.

After you finish the 3 cycles you may carry on having just interferon treatment. You may have this for up to 18 months if your doctors think it is helping you.

The doctors will take a number of blood samples to see how the treatment is affecting your immune system. You will have 10 extra blood tests during your treatment and one more at the end of the trial.

If you are in group 2, you will have interferon alone. You will have this as an injection 3 times a week. You will have this as an injection, either under the skin (subcutaneous), or into a muscle (intramuscular). You will have the treatment for up to 18 months if your doctors think it is helping you.

Hospital visits

You will go to the hospital to see the doctors and have some tests before you take part in the trial. These include

Physical examination
ECG
Blood tests
CT scan

If you are in group 1, you will go to the hospital for 4 days at the beginning of each treatment cycle to have the ABR-217620 injections. You may have to stay in hospital for the 4 days that you have the injections. If it is possible for you to have the treatment in the outpatient department, you will have to stay there for at least 6 hours after the injection. This is so that the doctors can monitor you closely.

Before each injection of ABR-217620, you will have an infusion of fluid into your bloodstream (intravenous infusion). You will have paracetamol tablets to reduce the side effects of the drug. You may also have other medicine, for example medicine to stop you feeling sick.

You will have your interferon injections at home. The trial team will teach you how to give yourself the injections. Or they can arrange for a district nurse to visit you at home to give them. You will see the trial doctors at least 11 times and have regular blood tests during the first 6 months of treatment.

If you are in group 2, you will have your interferon injections at home. But you will have to go to the hospital at least 8 times during the first 6 months of treatment. You will have a blood test each time you go to the hospital.

Both groups will have a CT scan

After 3 months of treatment
After 6 months of treatment
Every 3 months for 5 years after that

When your treatment finishes, you will see the trial doctors every 3 months for follow up appointments.

Side effects

As ABR-217620 is a new and experimental treatment, there may be side effects that doctors don’t know about yet. In earlier trials, the most common side effects were