We returned to hospital today after an interval of week without medication to see if Steve's heart rhythm had improved enough to allow him to continue taking part in the VanSel early phase drug trial.
As you can imagine, we felt rather apprehensive as we waited for the results of this morning's ECG and blood tests. Would the heart's "QT" interval (which measures electrical activity in the ventricles) have dropped below 180, the maximum allowed under the drug trial protocol?
After what seemed like an agonising wait, Juliana the clinical trial nurse appeared and told us the news. Steve's ECG was "better" - good enough to carry on with the trial but on a reduced dose of vandetanib, one of the two biological therapies being tested in this dose escalation study.
Steve was the first person in the current drug trial cohort to have the higher dose of vandetanib. Based on his experience alone, increasing the dose runs the risk of patients having heart problems. It remains to be seen whether the other five patients in the cohort can tolerate the higher dose or, like Steve (whose natural "QT" interval is longer than average), experience problems which pose an unacceptable risk.
There was another interval while we waited for the blood tests results to come back - all good, I'm pleased to say - and to find out from the drug company how the reduction in vandetanib would be administered.
The word came back eventually that Steve would take a reduced dose of the drug on a daily basis, rather than the higher dose every other day. We heaved a sigh of relief...that will make life a lot easier, not having to remember whether he is on a vandetanib dose day or not! He will continue to take the other trial drug, selumetanib, at the same dose twice a day at 11.30 am and 11.30 pm.
So....after an interval of week, we are back on the VanSel track, with regulated feasting and fasting times.
The drug trial clock has re-started. Today is Day 36 of Cycle 1, which lasts 42 days. Assuming all goes well on the reduced dose of vandetanib, by the time of his next hospital visit, he will be starting cycle 2 of the drug trial which is only 28 days long. That cycle will be followed by a scan. Then we will know what effect these therapies are having on the meso.
In the meantime, the close monitoring continues with another eye test tomorrow and an echocardiogram, both of which take place outside the hospital complex so a slightly different routine for a change.
We will of course be doing our own monitoring and hoping that Steve's skin does not flare up again as badly as last time, now that he's back on the drugs. His face is still not back to normal, but at least the rash just looks like ordinary teenage acne now rather than the weeping sores, scabs, flaking skin and numerous inflamed pimples on a red background that he's had to put up with until recently (sorry if that's too much information....)
Good luck and a big hug to Tess, who is re-challenging her meso with her fourth line chemo since diagnosis xx.
As you can imagine, we felt rather apprehensive as we waited for the results of this morning's ECG and blood tests. Would the heart's "QT" interval (which measures electrical activity in the ventricles) have dropped below 180, the maximum allowed under the drug trial protocol?
After what seemed like an agonising wait, Juliana the clinical trial nurse appeared and told us the news. Steve's ECG was "better" - good enough to carry on with the trial but on a reduced dose of vandetanib, one of the two biological therapies being tested in this dose escalation study.
Steve was the first person in the current drug trial cohort to have the higher dose of vandetanib. Based on his experience alone, increasing the dose runs the risk of patients having heart problems. It remains to be seen whether the other five patients in the cohort can tolerate the higher dose or, like Steve (whose natural "QT" interval is longer than average), experience problems which pose an unacceptable risk.
There was another interval while we waited for the blood tests results to come back - all good, I'm pleased to say - and to find out from the drug company how the reduction in vandetanib would be administered.
The word came back eventually that Steve would take a reduced dose of the drug on a daily basis, rather than the higher dose every other day. We heaved a sigh of relief...that will make life a lot easier, not having to remember whether he is on a vandetanib dose day or not! He will continue to take the other trial drug, selumetanib, at the same dose twice a day at 11.30 am and 11.30 pm.
So....after an interval of week, we are back on the VanSel track, with regulated feasting and fasting times.
The drug trial clock has re-started. Today is Day 36 of Cycle 1, which lasts 42 days. Assuming all goes well on the reduced dose of vandetanib, by the time of his next hospital visit, he will be starting cycle 2 of the drug trial which is only 28 days long. That cycle will be followed by a scan. Then we will know what effect these therapies are having on the meso.
In the meantime, the close monitoring continues with another eye test tomorrow and an echocardiogram, both of which take place outside the hospital complex so a slightly different routine for a change.
We will of course be doing our own monitoring and hoping that Steve's skin does not flare up again as badly as last time, now that he's back on the drugs. His face is still not back to normal, but at least the rash just looks like ordinary teenage acne now rather than the weeping sores, scabs, flaking skin and numerous inflamed pimples on a red background that he's had to put up with until recently (sorry if that's too much information....)
Good luck and a big hug to Tess, who is re-challenging her meso with her fourth line chemo since diagnosis xx.
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