Day 65: Decisions Decisions – Clinical Trials

Since D day the topic of clinical trials was broached by our consultant. At the time I remember feeling numb to pretty much everything they told us. However the clinical trials was always something that I felt mildly uncomfortable about.

For me personally the trials come with a huge morale dilemma, as well as a very personal dilemma.

This post is pretty heavy on the treatment path and “cancer speak” as with all our posts we hope that it will help those not in our club understand a little bit about our world. I’ve added headers so you can skim through.

What do I know about cancer?

When we started on this journey not very much. My grandad died of bone cancer, he was old. My other grandad also died of cancer, he wasn’t so old but I wasn’t involved in his care. I’ve had family members with breast cancer.

And through the grapevine of life I know a few people who have grown angel wings before their time thanks to bastard cancer.

I certainly didn’t know much about childhood cancer. Here are a few facts for you from childrenwithcancer.org.uk

  • Childhood cancer is rare – around 1,600 new cases are diagnosed every year in the UK (in children aged 0-14 years)
  • This means that around one child in 500 will develop some form of cancer by the age of 14 years
  • Childhood cancers account for 0.5% of all cancers in the UK
  • Cancer occurs more commonly in boys than girls, by a ratio of around 6:5. This varies by tumour type; the most striking excess is in lymphomas, which boys are more than twice as likely to develop
  • In Britain, childhood cancer incidence rates increased by 38% between 1966-2000. Some of this increase is thought to be due to improvements in diagnosis and registration
  • The childhood cancer rate in the UK is the lowest in Europe, and one of the lowest of all Western industrialised countries. Australia and the US have some of the highest rates. The reasons for this variation are not clear.

Reading this pre-cancer diagnosis would have been comforting. I would have assumed it wouldn’t ever happen to us. But it did and here we are.

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The Lego gift to MK hospital was a life saver. When Bilbo is in hospital he has to go in a side room and is not allowed to go to the playroom or play area. The hospital is full of very sick little people and Bilbo needs to avoid getting bugs whilst on the ward. Visiting MK is very different to the Kamran ward in Oxford where he can wander about and even have his treatments and meds in the playroom.

And what is terrifying to me is the following:

Since 1980, fewer than 10 drugs have been developed for use in children with cancer. Only three drugs (Teniposide and Clofarabine, and Unituxin for use in high-risk neuroblastoma) have been approved for use in children. Only four additional new drugs have been approved for use by both adults and children.

Source: National Pediatric Cancer Foundation

Moral Dilemma

SO this leads me to our moral dilemma. Over the last 50 years, if children suffering from Leukaemia and their families, hadn’t put themselves forward for trials. Then the type of treatment that is available for Bilbo today might not exist. His 90% survival rate could be much much lower.

We signed the trial and research paperwork on D day on the basis we could change our mind at anytime. And in the first few weeks it was pretty straightforward. I filled out a questionnaire about Bilbo and his reaction to steroids. Bilbo was asked to complete a couple of computer tests. It was all very easy.

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We’ve agreed to be part of some research and trials. This is a computer test, Bilbo was brilliant.

BUT now we coming to the crossroads where our decision to be in the current UK trial is more than just a survey and a computer test. The implication of the trial is huge and will have massive impacts on the rest of Bilbo’s treatment.

Personal Dilemma

And that is why it is a huge personal dilemma. Up to this point Bilbo’s treatment plan has been dictated by our cancer team. We’ve done our own research, we’ve joined support groups in order to be the very best parents we can be to help Bilbo. BUT now shit gets very very real. Rich and I need to think through all the scenarios and make the decision to opt in or out.

What is a trial?

I won’t try to re-write the experts so here is bloodwise’s explanation:

Clinical trials for childhood acute lymphoblastic leukaemia (ALL)


If a clinical trial (study) becomes available while your child is being treated, your consultant may recommend you consider enrolling them in it.


Clinical trials are done for several reasons, including to look for new treatment options and to improve existing treatments. Taking part in a clinical trial has many advantages, such as the opportunity to have the newest available treatment which may not be offered outside the trial. Your child will also be very closely monitored and have detailed follow-up.


In a clinical trial, the best treatment available is compared with one that could be better – so your child will either have the current best available treatment, or the new one which could be better. Your child will still receive all the normal care that the NHS provides whilst they’re taking part in the trial.


Taking part in a clinical trial does come with uncertainties, so you may prefer that your child doesn’t take part. If you don’t want your child to be in a trial, or there isn’t a suitable trial available, they’ll be offered the best treatment available that’s suitable for their condition.


Bloodwise research trials: https://bloodwise.org.uk/info-support/childhood-acute-lymphoblastic-leukaemia/research-trials

UKALL 2011

UKALL 2011 is the current trial and is the one we need to decide to opt in or out of. More details are here.

What does it mean for Bilbo?

If you recall we moved to regimen C after induction. And this means the following for Phase 3: interim maintenance:

Children on regimen C will have a more intensive course of chemotherapy involving methotrexate. Your child’s doctor will explain to you exactly how this treatment is given because this will depend on whether your child is taking part in the UKALL 2011 clinical trial or not.

Bloodwise.org

If we opt into the trial, we will be randomised and this will mean a computer will churn out whether we get:

Standard (Capizzi) interim maintenance

OR

High-dose methotrexate (MA)

It is significant because the protocol for each option varies quite substantially. Both options have their pros and cons. After talking to our consultant on Wednesday, it is clear that this phase isn’t going to be an easy ride for Bilbo whatever the outcome is from the randomisation.

Capizzi (standard)

Means Bilbo having IV (intravenous) methotrexate once every 10 days as an outpatient. The dose starts low and is gradually increased each time until we achieve the maximum that your child’s body can manage.

WTF!!! This sentence makes me feel physically sick. “your child’s body can manage”

High-dose methotrexate

Is a higher dose of methotrexate. Bilbo would get four courses once every two weeks and involves him being in hospital for 4-5 days attached to drip. He will also get the methotrexate intrathecally which is through a lumbar puncture under general anesthetic.

MA will also mean he won’t get further intrathecal treatment in the 5th (maintenance) phase. No lumbar punctures during the 3 years of chemo Bilbo has to endure.

The trial randomisation will also determine if Bilbo will have to have pulses (a combination of steroids and vincristine (chemo drug)) during maintenance.

Have I lost you yet?

I appreciate this is an incredibly heavy post with a lot of information. Perhaps more information than someone might expect us to share. But this isn’t a super personal journey just for Bilbo.

This is the path that all patients with ALL take. The treatment path is relatively standard UNLESS there are complications, Bilbo has a reaction or he gets unwell (other than bastard cancer)

And this decision is one other parents also have to take.

We don’t have to decide right now, we have a few more weeks but this is weighing heavy on our mind.

In short if we opt in to the trial the computer decides one of the following routes for us:

  1. Std Capizzi with pulses in maintenance
  2. Std Capizzi without pulses in maintenance
  3. High dose mehtotrexate with pulses
  4. High dose methotrexate without pulses

How is Bilbo doing right now?

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Bilbo’s energy is insatiable (not complaining) so we’ve been enjoying lots of fresh air and pulling his school friends along in a wagon.

We stayed out of hospital over Christmas and New Year – HURRAH! But the combination of chemo medication has taken its toll. He lost his appetite and taste. But not his energy – he has that by the barrel load.

On Wednesday we were back to Oxford for a lumbar puncture and bone marrow test. This is the half way test to see how the lastest treatment is doing. We should get the results in just over a week. And we had more chemo today in Milton Keynes.

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On Wednesday we took H to hospital with us. He had a blast.

We were given the news on Wednesday that Bilbo gets a rest. This means he has some time to recover, get his tastebuds back to normal and enjoy food.

Our plan is to have Bilbo return to school with his friends on Monday and try and have a week of relative normality. Giving Bilbo’s bloods some time to recover.

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We’ve also been trying our hand at pottery painting. We can’t wait to share the finished article.
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Bilbo has begged us for weeks to go to Build a Bear. He had some Christmas money (thanks Grandad) and used it to buy a very special dinosaur.
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Of course we can never get anything for one without the other. So here’s our pair of dinosaurs – Adventurer and Dinosaur

The next round for this phase will resume once we have his results and get the green light. We now know that the combination of chemo in this phase makes Bilbo very sick, so we will try and manage it a little better with the anti-sickness medicine.

Keep us in your thoughts and send us positive vibes for Bilbo heading to school on Monday.

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3 Responses

  1. Irina Barratt says:

    I hope Bilbo will enjoy food once his taste buds are back to normal. Do you think he might like some homemade lasagne?

  2. Kath says:

    Sending hugs and positive vibes to you all Kath xx 😘💖😘

  3. Darren Allford says:

    Thinking of you all and sending love and strength – you’re doing absolutely brilliantly and Bilbo is a little star. xxx

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