19. What Trial & Why

Malignant Melamona is in many ways a rare cancer. It is on the increase –a  rapid increase unfortunately. But when I refer to it as “rare” I simply mean that in comparison to something like Breast Cancer or Prostate Cancer it isn’t as common.
Skin cancer is common – but there are many, many different types of skin cancer & MM only makes up 4% of Skin Cancers. In the UK more than 11,500 cases of Malignant Melanoma are diagnosed every year, and in 2013 over 2,500 people in England will lose their battle.
With many other cancers there are a far greater variety of drugs available – to treat and even cure the Cancer. Don’t get me wrong – cancer is cancer & is scary and horrible no matter what form you get diagnosed with. But when you get MM you face a scary prospect – no cure.
There are various drugs that are currently used to extend life & delay the inevitable – some with more success than others – many with serious side effects. There are some positive vibes and signs of progress coming out of various drug trials – these drug trials are not for new drugs (there haven’t been any new Melanoma Drugs available to my knowledge in over 5 years), but the trials are for existing drugs at different time points or for combinations of drugs.
A bit like guinea pigs – clinical trials offer the patient a hope – a chance that this might be the one thing that helps us – but also provides the medical profession with potential results, data and information that in turn can help future Melanoma sufferers even if that one particular drug doesn’t do the trick for them.
My Melanoma was bad – bad enough to make me a potential candidate for one such clinical trial. The trial that I am in the process of starting is for a drug called Vemurafenib which is a drug that is already on the market & given to Melanoma patients where the Melanoma has metastasised or spread further into the body.
The title of the trial is “ A Phase III, randomized, double blind, placebo controlled study of Vemurafenib (R05185426) Adjuvant therapy in patients with surgically resected, cutaneous Braf-Mutant melanoma at high risk of recurrence”
All that sounds like oble-di-goble-di-goop…I know……
So the idea of the trial is this: this drug is currently given (not always on the NHS and not to everyone) at a later stage, it has been shown to work, as have many other drugs – it stops / delays the effects of Melanoma & it’s spread for an indeterminate amount of time (generally 2-3 years) after which the delayed cancer returns with a vengeance.
If however they give the drug at a point before the cancer has spread, will it stop it ever spreading…??
Hence the trial.
Who knows – they hope it to be the case – the trial is a massive trial across 30 locations all over the world.
But it is a double blind, placebo controlled study – so at this point nobody knows if I will get the drug or the placebo…..we will soon know (when it starts) because of the various side effects.
There are quite a few of these & I will go through the side effects in more detail some other time.
The good thing for someone with Melanoma about a trial is the tests.
I have explained this before, but at the risk of repeating myself I will say it again….If I don’t go on a trial then the only option available on the NHS is routine monitoring which consists of a 3 monthly visual check up with a Dermatological nurse who will also feel my lymph nodes for changes. I would also get a CT scan every 2 years.
But you see Melanoma moves – it hides dormant & suddenly decides to come back somewhere else…like a child playing a game of hide & seek…..but it has nasty mean teeth & bites – the little shitbag!!
I personally do not think that a 3 monthly check up is enough when you are told that you are “high risk”. So the trial is my best bet – because on the trial I would get a thorough, vigilant, scrutinous & in many ways invasive examination every 28 days or more frequently.
They do the usual lymph node checks, the visual examinations, & they do scans, blood tests, cameras up & down every hole in my body. Sounds invasive & it will be.
This sounds like a leap of faith & in many ways it is…..if I get the drug it might not work – I get that – I totally understand the nature of this cancer.
I just hope that I can show you – explain to you – and that you can explain it, through me, to someone else & so on…so that when they have a mole on their back or wherever, that annoys them because it catches on clothes or looks “different” they don’t just leave it or ignore it, or accept a brush off from a consultant – they demand that it gets checked out…because until there is a cure…if there ever is one….all we have is trials…..vigillance…..time……. & hope.