VanSel1 biological drug trial Cycle 1, Days 15-16: Bloods, drugs and tests

It feels like we have spent the last two days in hospital.

We knew that Monday would be a long day in Bay 34.

Bay 34, our "home" for the day on Monday

It was the day when Steve gave "research" bloods for testing over a 24 hour period to see what effect the trial drugs were having on his body and what effect his body was having on the trial drugs. These are called PK samples, short for pharma kinetic (the disposition of a drug in the body over time, used to guide adjustments in the dosage and interval of drugs for maximum therapeutic results and minimum toxic effects).

It was also the day Steve would have all the usual observations (physical examination, blood pressure, temperature, pulse, urine, normal blood tests and an ECG) to make sure he's still OK before starting the second trial drug, selumetanib, in addition to the vandetanib which he has now been taking for two weeks.

Because of all the tests, we were in hospital well before 9 am to make sure that the blood test results were back to get the all clear in time for Steve to take both trial drugs at 11.30 am. This is the dose time that fits in best with our pattern of eating, as he must not eat or drink anything except water for two hours before and one hour after taking the drugs.

The first set of bloods went missing somewhere in the hospital's pneumatic internal postal system, so a second set of bloods were taken and carried to haematology by hand. However, because of the delay, Steve wasn't allowed to take his drugs until 11.47, pushing the subsequent research blood samples back 17 minutes. Not a long time in the scheme of things, but psychologically it felt a lot longer being closer to the hour than the half hour! It also meant that Steve would not be able to take his second selumatenib capsule until approaching midnight (as it should be taken at 12 hour intervals).

The rest of the day in hospital was routine if long, with PK research bloods being taken at 30 minutes after the drug dose, then at two, four, six and ten hours after the dose. We passed the time reading, watching a movie on the laptop, doing sudokus and crosswords (Steve) and taking photos on the iPhone (me) until the battery ran out.

The Clinical Trials Unit ward was nearly empty when we left the hospital, but by the time we arrived home, Steve had started to feel unwell, visiting the loo and downing imodium tablets with increasing frequency. When he started feeling nauseous, clammy and dizzy it was clearly time to contact the hospital for advice.

The body is a strange thing. In the five minutes or so between phoning the oncology ward and the doctor returning our call, it was like a switch had flipped. The nausea and dizziness stopped, and Steve suddenly back to "normal". Having talked to the doctor on the phone, it was agreed that there was no need to go back to the hospital that night, although a bed would be available for him should he take a turn for the worse.

Steve took his second dose of selumetanib approaching midnight, and not long afterwards we went to bed, bucket at the bedside just in case (although I'm pleased to say it was not needed!)

Yesterday morning, we were back in hospital again to give the last PK research blood sample 24 hours after the drug dose and talk through what had happened the evening before with Dr Ioannis. Only then did we realise that Steve had been told NOT to take the selumetanib the night before when talking to the doctor on the phone, in case he had another bad reaction. In the event no harm had been done as he was, and is, still feeling fine.

Room 18, our "home" for much of Tuesday

There was the usual fun and games trying to find a vein where the cannula could be inserted. It took several attempts by two nurses in both arms, but eventually it was sorted out and blood samples taken both for research (the PK bloods) and to check that Steve's liver function had not been affected by the episode the previous evening, before he would be allowed to take the next dose of selumetanib.

Bruises on earlier cannula sites and dressings over Tuesday's failed attempts to insert a new cannula

As "dose time" approached with no sign of the blood results, there was another discussion with the Dr Ioannis about whether or not to take the second trial drug. In the end, it was agreed that Steve would take the selumetanib just before the hour "window" of dose time closed so that he could continue with the trial, but would stay in hospital until the blood test results had come back and the doctor was happy that no harm had been done. So we settled in again, reading newspapers while waiting for the all clear which eventually came mid-afternoon with the news that his bloods were A-OK.

We have been speculating about what might have caused the episode on Monday night. It could have been a reaction to the first dose of selumetanib, but in that case, why has he not had a similar reaction with subsequent doses? It could have been a reaction to something he ate, unrelated to the drug trial, and once it was out of his system, all was well. It could have been a reaction to the imodium taken several times in a short space of time. The bottom line is we don't know. But we did the right thing contacting the hospital and that's what we should do if anything like that happens again.

So here we are, well into the first cycle of the VanSel trial with Steve now taking both trial drugs. Other than the mini-crisis on Monday evening, which was over within three hours and has not recurred, everything seems to be going well.

We are hospital-free for the rest of this week, so once we have caught up on things that were set aside over the last two days, we can think about giving ourselves a treat. Steve has been looking the the National Trust handbook, so who knows where we will end up? As long as he remembers to take his tablets with him.....

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Selumetanib, Vandetanib, VanSel1

Wednesday, February 19, 2014

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VanSel1 biological drug trial Cycle 1, Days 15-16: Bloods, drugs and tests

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