Trial 1 Day 1 & 2

What a long couple of days!
We left the house at 6a on Thursday, dropped Bruski off at his nanna and papa's house for a sleepover, then made our way into Boston.  My first 2 vile blood draw was at 8a, another at 10a, another at 12p, then I took the oral meds, the IV treatment was administered over a one hour period, blood was drawn again at 1p, 2p, 4p, and 8p.  Unrelated to the medication, I had a fever beginning around 2:30p on Thursday, and I'm still monitoring it today (Sunday), although it seems to be tapering off.  Friday was shorter and less of a hassle, we arrived at 11:30a, my first blood draw was at noon, then I took the oral meds, and had blood drawn again at 2p before we were free to go at 2:30p.  The docs have me tracking the fevers and every medication that I take, including Tylenol.  Out of all of this, including the failed attempts at trying to find a vein and new nurses that have never seen a femoral port, the most annoying part of all might have been the old guy sharing a room with me yelling out prices on The Price is Right; how am I supposed to calculate my guess if you keep yelling your guess over and over again?!  I might have been secretly satisfied every time he was way off!  :o)

I did get the results of the ct scan that I most recently had.  The findings of the ct scan are based on a scan that was done exactly one month prior to this one.  The scan showed that there was significant growth in many of the liver tumors, some a little over 1cm, and there is a tumor in my lung that has appeared.  Let's hope that this is a fast acting drug!

Monday should be a short day with just one blood draw prior to taking the oral treatment. The nurses did warn us that "there is no normal day", which we know from years of experience, but we can always hope that things go smoothly. 

UPCOMING APPT:
10/29: Blood draw & Dose

Approved

I just got word that after the extensive screening process, I have been approved for the clinical trial using SAR245408 in combination with SAR256212. I will begin treatment this Thursday, October 25, 2012.


The trial schedule requires me to arrive at BI at 8am and spend 8-10 hours at there on Thursday for IV dosage, oral dosage, labs, EKG, physical exam, and research blood samples; 3-4 hours at BI on Friday for oral dosage, labs and research blood samples; and 2-3 hours at BI on Monday for oral dosage, labs and research blood samples. This schedule gets repeated next week as well, and then drops down to just the 8-10 hour Thursdays for the following two weeks, before the cycle starts over again. Thursdays require me to fast starting at midnight until my first labs are drawn, then I can eat something quick, and then resume fasting for 2 hours before taking the oral dose, and then I have to fast again for one hour before being able to eat – or more importantly drink coffee! Labs are drawn constantly throughout the day, including at the same time as the IV dose is being administered, I’ll give you a tally after Thursday - it should be an interesting day.

As my nurse, Linda, told me “every approved treatment started off as a phase one clinical trial”; let’s hope this is the next best up and coming treatment.

UPCOMING APPTS:
10/25, 10/26, 10/29
11/1, 11/2, 11/5
11/8
11/15

Short Game

Well the waiting game ended up being shorter than we’d thought it would be, not for the results of the tumor snapshot, which of course is taking longer than expected. I received a call Monday night from the Phase 1 clinical trial RN, Sue, asking me to come into the office on Tuesday to talk about, and potentially sign the consent form for, a trial that has come about. Sue stated that both Dr. H and Dr. Cho agreed that it would be a worthwhile attempt, even though we do not yet have the results of the snapshot.

As with our first appointment with Dr. Cho and Sue, the meeting proved to be overwhelming. Even though Sue emailed me the 26 page consent form which I read through thoroughly, there was still an abundance of information and changes to take in.

This trial uses two drugs (SAR245408 and SAR256212) that have been used before, but are being used in combination for the first time; one is an oral drug taken daily and the other is administered through an IV weekly. This trial is at tier 4, which means that this is the fourth increase of the dosage for this combination of drugs; which is very good for me because it means that the dosage is at a level where it could actually help, instead of the under-dosing where a phase 1 trial must begin. I have been told that these two drugs seem to be tolerated well, and that other chemotherapy drugs that I have been on are harder to handle than these are. It all seems fine and dandy right? Well, there’s always a catch.

I stated in my last post that phase 1 trials were extremely time consuming, and I heard them say this, and I took in this information; but, I did not fully comprehend how much time and money being in a trial would entail, until this last appointment. Prior to being accepted in the trial I must go through a screening process: ct scan, echocardiogram, blood work, physical exam, and an EKG. Assuming that I am eligible following the screening process, I will begin the trial Thursday, October 25th. Being on a trial not only means that I had to change doctors, but it also means that I will be treated in a different building with different nurses and staff – it’s like starting all over again. I will go into more detail about the trial schedule after Monday’s appointment. I’m going to take this new venture one step at a time.

UPCOMING APPTS:
10/20: CT Scan
10/22: Echocardiogram, blood work, physical exam, EKG

The Waiting Game

Our first meeting with Dr. Cho was a basic introduction.  He explained to us what phase one clinical trials are and how they work, the following is what I took from the meeting.  Phase one means that it is a brand new drug or the first time that two already existing drugs are being combined and used for treatment.  The trials currently being performed are using targeted drugs, meaning that the drug blocks a certain pathway of the cell to block growth and production of the cancerous cell.  In order to find out which pathway my cancer is using they must study the mutation of the cancerous cells.  The tumor that was extracted from my thymus a couple years ago will be sent to Mass General to be studied and the results given to Dr. Cho so that an appropriate trial, if any, can be chosen.  If the exact mutation cannot be identified I will either have my name submitted to enter a trial that blocks two of the most common pathways, or I will possibly be put on an already FDA approved chemotherapy drug that has shown some success in one thymic carcinoma case study.  It will take three or so weeks to receive the results of the mutation study from Mass General, so for now it's back to the waiting game. 

Other general trial information: 1. side effects can be unpredictable 2. trials vary but can be extremely time consuming  3. three people are assigned to each designated dosage of the drug, if the dose is too strong for a person at their assigned dosage they can lower the dosage but are no longer useful to the trial study. 4. if a person is taking a drug that is working for them, but the drug is being removed from trial, that person can remain on the drug that is working for them. 5. there is no limit to the number of trials that you can participate in.

There is a lot of information to take in and I'm sure I didn't get it all, but as with everything, we will take it one step at time.

UPCOMING APPTS:
TBD

One of those Days

Thursday, September 27, 2012 gets filed under the category of "one of those days".  We arrived for my appointment at BI hopeful and anxious to receive the results of my most recent ct scan and head MRI; but first thing is first, having my blood drawn and port flushed.  What is normally a smooth and tedious process becomes more of a procedure when someone new is taking care of it.  I love my normal nurse, and yes she deserves vacations, but I don't have to like when she's not there.

Following the blood draw/port flush we headed back into the waiting room to do just that, wait.  Fifteen minutes after my appointment time we were taken back to a freezing exam room, and waited some more.  After waiting, and freezing, for an hour and a half Dr. H finally came into the room and apologized for the delay.  He then proceeded to tell us that the head MRI was fine; but, the ct scan showed that the Sutent wasn't working.  Although one of the larger tumors in my liver was a bit smaller, several new tumors had appeared; there are currently about a dozen tumors spread throughout my liver.

We have exhausted all of the current treatment options that are available for thymic carcinoma, therefore our next step will be to meet with a BI Phase One Clinical Trial doctor.  From the brief description that I have, a phase one trial is the starting point for a new drug, the purpose is to experiment with the dosage, the effectiveness of the drug is a secondary concern to the physicians.  Clinical trials have limited openings, and can take place at various hospitals.  We were lucky enough to get an appointment with Dr. Cho, a BI clinical trial doctor, today (Mon. 10/1) where we will receive more information about the process and wait time to be accepted into a trial. 

After being in the frigid exam room for so long I couldn't warm up, my entire body was shivering for over an hour, my muscles hurt from the tightening and shaking, which I imagine is what led to the 3 day migraine that I had all weekend.  Now it is Monday, I am back to work and awaiting our afternoon appointment to learn about the next step in this battle.  I can only hope that Dr. Cho will have some uplifting information to share with us.

UPCOMING APPTS:
Monday, October 1st - first meeting with Dr. Cho, intro to phase 1 clincial trials