A trial looking at RAD001, interferon and bevacizumab for kidney cancer that has spread

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Kidney cancer

Renal cell cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at having either bevacizumab (Avastin) and RAD001 or bevacizumab and interferon as the first treatment for clear cell kidney cancer that has spread. (Bevacizumab is pronounced bev-a-siz-oo-mab.)

The most common type of kidney cancer in adults is renal cell cancer. And the most common type of renal cell caner is called clear cell cancer. If the cancer has spread outside the kidney, it is called metastatic clear cell kidney cancer.

If possible, doctors use surgery to treat kidney cancer. But if the cancer is advanced when you are diagnosed or comes back after surgery, you may have biological therapy.

Biological therapies are treatments that use natural substances from the body, or drugs made from these substances. Interferon and bevacizumab are 2 types of biological therapy that doctors may use to treat advanced kidney cancer.

RAD001 is also known as everolimus and Afinitor. It is a drug that was first developed for people who’ve had a heart or kidney transplant. It helps to damp down the immune system to stop the body rejecting the new organ. We know from research that RAD001 may also help to stop cancer cells growing.

In this trial, researchers will compare a combination of bevacizumab and RAD001 with a combination of bevacizumab and interferon. The aims of the trial are to

See which of these 2 drug combinations is best for people with metastatic clear cell kidney cancer
Learn more about the side effects of both drug combinations

Who can enter

You can enter this trial if you

Have renal cell cancer that is at least partly clear cell type, and has spread
Are well enough to take part in the trial
Have satisfactory blood and urine test results
Are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have cancer that has spread to your brain or spinal cord
Have had part of your kidney removed (partial nephrectomy) and your surgeon was not able to remove all the cancer with a border of cancer free tissue round it (clear margins )
Have had major surgery in the last 4 weeks or minor surgery in the last week
Have had radiotherapy in the last 4 weeks (you may have had radiotherapy to relieve symptoms caused by cancer spreading to the bones in the last 2 weeks)
Have already had drug treatment for kidney cancer that has spread (you may have had vaccine treatment after surgery to remove the cancer as long as it finished at least 3 months ago)
Have already had treatment with drugs that target VEGF such as sunitinib, sorafenib or bevacizumab
Have had another experimental drug in the last 4 weeks
Have already had RAD001 or similar drugs such as sirolimus or temsirolimus
Are known to be sensitive to interferon, RAD001 or similar drugs
Have had treatment for any other type of cancer apart from non melanoma skin cancer or carcinoma in situ of the cervix in the last 3 years
Are likely to need to have surgery during the trial (your doctors can advise you about this)
Have had a wound or infection in your tummy (abdomen ) that has caused an abnormal opening (an abdominal fistula ), a hole in the stomach caused by a wound, or a collection of puss in the abdomen (an abscess) in the last 6 months
Have a broken bone or a wound that isn’t healing
Have ever had fits (seizures) that couldn’t be controlled with medication
Have high blood pressure that cannot be controlled with medication
Have had a heart attack or stroke in the last 6 months
Have any medical condition that causes abnormal bleeding or blood clotting
Have any other medical condition that cannot be controlled with medication, including (but not limited to) angina, heart failure, lung disease, liver disease, poorly controlled diabetes or an infection
Are taking blood thinning drugs or steroid tablets (you must not stop this type of medication without talking to your doctor)
Are known to be HIV positive
Are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit about 360 people. The people taking part will be put into one of 2 treatment groups by a computer. Neither you nor your doctor can decide which group you are in.

If you are in group 1, you have bevacizumab through a drip into a vein every 2 weeks. And you have interferon injections under the skin 3 times a week. You can give yourself these injections at home.

If you are in group 2, you have bevacizumab every 2 weeks and you take RAD001 tablets every day at home.

You can carry on having the treatment for as long as it helps you.

You will be asked to fill out some questionnaires before you start treatment, every 2 weeks during treatment, at the end of treatment and then a month later. The questionnaires will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

If possible, the trial doctors will get samples of the tumour tissue that you had removed during surgery or when having a biopsy Open a glossary item . And they will take blood samples during your treatment. This is so that they can try to find substances they can measure in the body to help them tell how treatment is working. They call these substances biomarkers .

The researchers will also ask your permission to take extra blood and tumour samples to study your genes. This is to learn more about how genes can affect who gets clear cell cancer of the kidney and the way people respond to treatment. If you don’t want to give these samples for genetic research, you don’t have to. You can still take part in the trial.

If you are in group 2, you will have extra blood tests during treatment. These will help the trial team to learn more about the way RAD001 works in the body. This is called pharmacokinetics Open a glossary item .

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
Heart trace (ECG )
CT scan or MRI scan
Bone scan
Blood and urine tests

If you have cancer that has spread to your skin, the trial doctors will take photographs and they may take a sample of the cells (a skin biopsy).

During treatment, you go to hospital every 2 weeks. You see the doctors and have blood tests at each visit. And you have a scan every 3 months.

When you finish treatment, you will see the trial doctors again within a week and then 4 weeks, 3 months and 6 months later. After 6 months, a member of the trial team will phone you every 2 months to see how you are. They will continue to do this until at least 2 years have passed since the last person entered the trial.

Side effects

The most common side effects of RAD001 include

Skin rash
Sore mouth
Tiredness (fatigue)
Sickness or loss of appetite
Headaches
Diarrhoea or constipation
A drop in the number of blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
High levels of cholesterol or glucose in the blood
Lung problems such as cough or shortness of breath