A study looking at dexanabinol for advanced cancer

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

Cancer type:

All cancer types

Status:

Closed

Phase:

Phase 1

This study is looking at dexanabinol for solid tumours. A solid tumour Open a glossary item is any type of cancer apart from leukaemia or lymphoma .

Doctors use treatments such as surgery, radiotherapy and chemotherapy to treat cancer. But sometimes cancers continue to grow or spread to another part of the body despite having all the standard treatments Open a glossary item . Researchers are looking for new drugs to help people in this situation. In this study, they are looking at a drug called dexanabinol.

Dexanabinol is a man made (synthetic) form of a chemical similar to that found in the cannabis plant. Dexanabinol does not have any cannabis like effects, but we know from laboratory research that it may affect cancer cells. This is the first time it has been tested in people with cancer. The aims of the study are to

Find the highest safe dose of dexanabinol
See what affect it has on your cancer
Learn more about the side effects and what happens to the drug in your body

Who can enter

You may be able to enter this trial if you

Have a solid tumour and there are no standard treatments available for you
Have cancer that can be measured on a scan or by looking at substances called tumour markers
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have satisfactory blood test results
Are at least 18 years old
Are willing to use reliable contraception during the trial and for a month afterwards if there is any chance you or your partner could become pregnant

If you’ve had treatment for cancer that has spread to your brain, you may be able to take part as long as this has not got any worse for at least 4 weeks before joining the trial.

You cannot enter this trial if you

Have not recovered from the side effects of other cancer treatment (apart from hair loss) unless they are very mild
Have had radiotherapy in the last 4 weeks unless it was radiotherapy to control symptoms
Have had chemotherapy in the last 4 weeks (6 weeks if you had mitomycin C or drugs called nitrosoureas )
Have had major surgery in the last 6 weeks
Have had another experimental drug in the last 4 weeks
Have hepatitis B, hepatitis C or another disease affecting your liver (apart from cancer)
Have certain heart problems
Have had a bad infection in the last 4 weeks or have any other medical condition that the study team think could affect you taking part
Are known to be HIV positive
Are pregnant or breastfeeding

Trial design

This phase 1 trial will recruit about 45 people in the UK. Everybody taking part has dexanabinol. The first few patients taking part will have a low dose of dexanabinol. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.

You have dexanabinol through a drip into a vein once a week. It takes about 3 hours each time.

Each 3 week period is called a cycle of treatment. You have up to 6 cycles of treatment. As long as you don’t have bad side effects and dexanabinol seems to be helping, the study doctor may talk to you about taking it for longer.

The study team will ask your permission to get a sample of your tumour that was removed in the past when you had surgery or a biopsy Open a glossary item . Depending on where your cancer is, they may also ask you to have a biopsy when you join the study and once more during treatment.

They will use these samples to look at how dexanabinol affects cancer cells. But this is optional. If you don’t want to give these samples for research you don’t have to.

Hospital visits

You see the study team and have some tests before you start treatment. The tests include

Physical examination
Heart trace (ECG )
Blood tests
Urine tests
CT scan or MRI scan

You go to hospital at least once a week during treatment. Each visit will last a few hours and in the 1st cycle of treatment, you may need to stay in hospital overnight on 2 occasions. This is because you have a number of blood tests at different times after having dexanabinol. Researchers will use these blood samples to learn more about what happens to the drug in your body (pharmacokinetics Open a glossary item ) and how it affects your body (pharmacodynamics ).

You have regular blood tests throughout your treatment. You have an ECG every 3 weeks and a CT or MRI scan every 6 weeks.

After you finish treatment, you go back to see the study team about a month later. You have a physical examination and more blood tests. You may have another scan.

Side effects

As this is the first time dexanabinol is being tested in people with cancer, there may be side effects we don’t know about yet. It has been looked at in trials with healthy volunteers, people having heart surgery and people with brain injuries. In these trials, the most common side effects were