I know some of you have been waiting for the information on the trial and I guess I have just been avoiding it. I'm kind of sick of talking it! But, because I love you all so much I will tell you:)
When we were at Vanderbilt last week I signed the informed consent and had some blood drawn. The week prior my tissue block from my very first surgery was sent to them. They will take the tissue block and check it to make sure that I do, in fact, have the B-raf gene mutation. MDA did this, however, the drug company must perform their own test. The blood draw was to see if I have have a certain genome in my blood that the medication needs to follow. These tests will take about 2 weeks to get back.
If both tests come back like we want them to, I will head back down to Vanderbilt for more testing. Not sure what they are looking for on this one, but the results for those will come back in 2 weeks also.
If THOSE tests come back like we want them to, I will start a very strict diet. No caffeine, no vitamins, no kale, no broccili, no apple juice no alcohol, blah, blah, blah. I have to be on this week for one week prior to beginning the trial. Honestly, I will probably start the diet the week before we find out the results so that I can start the trial as soon as possible.
We will head to Nashville the day before the trial starts and I will be hospitalized. Since this trial is taken in conjunction with a cocktail drug I have to be in the hospital for the cocktails to be given to me.
The cocktail drugs are:
*warfarin (blood thinner)
*omeprazole (used to treat stomach ulcers)
*dextromethorphan (in cough meds)
*midazolam (general anesthetic drug)
The first cycle, evening before day 1 to day 5, I will be given single oral doses of each of the interaction drugs. I will be hospitalized and blood will be drawn about every 15 minutes on day -1 to day 3. After that I will be released from the hospital and will return every 24 hours for labs.
The second cycle, day 6 to day 19, oral does of RO5 will be given. I can be home for this!! YIPPEE!!:) I will take 4 pills in the morning and 4 pills in the evening. These have to be taken at the same time every day and I will have to keep a journal.
(I am SO happy that I can be home in the middle of all this)
The third cycle, day 20 to day 25, I will return to Vanderbilt and will be hospitalizezd, I will be given oral doses of RO5 and the cocktail drugs. (the first cycle all over again)
Following the third cycle my diet can return to normal. In other words, hello Diet Pepsi:)
The remaining cycles, day 26 until I stop taking the study drug, I will be given oral does of RO5 and will return to the clinic on day 1 of each cycle (every 28 days) for scans and checks.
I can remain on RO5185426 until I decide to withdraw or it quits working.
Statistics are showing this drug works, on average, 6 months to a year. However, some people have been on it longer with success. One of the down sides to the drug is I will have about a 20% chance of developing Basal Cell Carcinoma. So, in other words, I am one a drug to kill my cancer, but in the mean time I have the possibility of developing another! Nice!
The side effects appear to be pretty mild. But, compared to biochemotherapy, ALL side effects are mild! Nothing and I mean nothing, is as bad as that. If you saw me during that time then you know what I mean! The most common side effect is fatigue. Big surprise! But, I'm a mom. I'm always tired!
Hope that answers some questions. If you are curious about anything, just ask. I will do my best to answer them.
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