Archive for June, 2014

Clinical trial 101

June 28, 2014

I’m a phase 1 lab rat, guinea pig, hamster…specimen.

Most Phase 1 trial participants are either so sick that they have zero options or in some cases a phase 1 can be a new drug for those who have no evidence of disease. My situation is that the cancer continues to grow while I try to manage the growth along with the side effects from the new drugs. I always put on a good show and look nothing like the rest of the clinical trial groupies, but when every day functions of basic needs get out of balance then I tend to show my true colors of fear, even panic, sadness, anxiety, and much concern.

With the clinical trial process, there are two closets and strangely enough one has a view of the ocean and one faces another building. The first closet is what I call the DTD (door to death). The participants in this room cannot walk without assistance and have that appearance no patient wants to see. Of course, this closet faces the building as if the staff know it doesn’t matter although it should. The second closet faces the ocean and was the place I visited for my long day. Also, the first closet is used for short infusions or blood draws. The rows of seats and pods are just too close together and are too close for my visual imaging or imagining. When feeling as I did full of side effects and cancer growth, I speak the truth. I answer with, “I’m not fine” and see their fear and concern in their eyes. It is not the concern for me as a patient, but fear their trial will be impacted. I get it, but the sights that surrounded me are not motivating and facing the wall of another building brings those walls closer with magnification of all my issues.
Key things to remember and understand when you are in a clinical trial are especially dose escalation:
1. Ask questions, and don’t stop until you get your answer
2. Have someone with you at all times
3. You are a specimen so no one cares about the cancer unless phase 2, communicate if you know things are getting worse. Their focus is drug toxicity.
4. Ask what cell lines are they targeting (Ie: which cancer)
5. Ask what happened to the rats in the lab
6. Ask about the cohort, number of people in each and if drug works can you switch to different arm of trial, and know what your dose is
7. Dose escalation may not mean you will get a higher dose depending on what cohort you are part of.
8. Understand who is part of hierarchy:
Coordinator, project manager, doctor who sees patient, data cruncher, lab “rats”
9. find out if study pays for anything:
parking, meds etc…your insurance may have to pay for drugs, procedures, labs etc…
10. add to your job list a new job of clinical trial true real coordinator: ie pre meds, bandages for port, schedule, meds outside of trial drug since the one who you are introduced to
just makes appointments, your oncologist is the one who knows your history, clinical trial peeps don’t know and really don’t care
11. if trial needs you to get a drug which is offered for cancer, make sure it is covered for yours (ie: if it is not, as I was told at 4pm on a Friday, you pay for it or you don’t get into the study)
KEEP IN MIND:
Understand that you are a guinea pig or hamster or lab rat and NO WHEEL will be provided, forget the sippy bottle of water too. You are on your own. You must do the work. You must ask the questions. You must work with the numerous people to make an appointment, get the drugs plus all the other people you normally make appointments.
Now, since I am a new clinical trial coordinator, I must follow up on my medication confirming dosage and other important information. Also, since the many staff who do their individual jobs on the clinical trial train and who don’t communicate with each other even though I learned they are a very short walk down the hallway, I must now take the answers from what happened with the meds to the real coordinator, communicate the info from the scheduler, and add any info from the riddler who may be the only person who knows what is going on. The riddler continues to pose question after question without any concern for answers which I must find, ask others, and pass this info to the next person. Sound confusing? It is, but don’t let the game get you down as you have access to new exciting drugs which may work!
So, if anyone is wondering why I haven’t done much on any real life activities, you see that the answer is that I’m on the clinical trial train. I am riding this ride with the numerous side effects of drugs along with side effects of cancer growth. I have also been on the nausea cycle. More nausea requires more meds which results in more constipation which is compounded by the existing constipation brought by cancer growth. The key is to keep the nutrition in the body while having the body react as normal as possible. When blinded by nausea, the focus is lost and the goal of every day things go astray.  In this situation, the priority is what most people take for granted, simply eating, drinking, and eliminating. Each step becomes a crisis and must be managed. The more common occurrence is a bowel obstruction, so focus has to remain consistent. All other day to day activities are put aside. This is when a spouse or significant other becomes critical for your every day survival. I’m lucky to have a great support team.
My clinical trial train is weekly visits to UCLA which anyone knows how painful that is, plus it is Santa Monica I need to visit now. My treatment schedule and windows of freedom have become smaller.I am told that this drug combo takes 3 weeks to work, so stay tuned.  Any available window of opportunity that I feel somewhat human, I exit immediately. This really puts into perspective free time and summer has a whole new focus. I will continue to find my sunshine today and every day. I hope you find your sunshine. It is important to find your sunshine!

Look down: the kitchen is a dangerous place even without the sharp objects

June 11, 2014
Note to self, when you are a cancer patient look down where you step because one wrong move you can end up wiping out in your own kitchen. If you decide to wipe out, don’t do it before you are going for an initial visit for a clinical trial. Somehow, I slipped on a piece of plastic, into the oven door, flat on the floor. Blood was dripping down my face and I screamed for Alex who was playing basketball. He came with his friend and both remained calm even though they really wanted an ambulance to come. Thanks to a call to his mom who ran to my house with her hubby, all was assessed and evaluated. We all decided that if I was “normal” maybe we would just use liquid bandaid. Since I have the ole’ special immune system plus all the other issues, it is best to go to the ER. It is nice to have friends in high places who can get you into a room away from the germs in the ER. Poor Jim was called by Alex who told him, “mom fell down, hit her head, blood is everywhere, come home now.” Luckily, we called Jim back after I was iced up, but his heart palpitations continued when he saw my purple swollen face. We all went to the ER where the doc said glue is better than stitches when the skin comes together perfectly. Another adventure outside of days of isolation.
My time of isolation ended to realize that I am in a strange place of time without chemo not by choice and cancer growth continuing. Both things, I cannot do anything about, so I have to enjoy my days as much as possible. With the continual rise of the tumor marker, comes increasing a symptoms from cancer growth. Some symptoms are more glaring than others. Without the ongoing toxicity of chemo, my head seems clearer (able to answer Alex’s questions with somewhat clear mind), but the constant reminder with increased symptoms is difficult to put in the back of my mind. Instead when I awake each morning, I tell myself I am as good as yesterday to do things I want to do and ignore as much of the symptoms as possible. The last reading of the tumor marker put things into a tailspin as a scan had to be scheduled. This was all in an effort to enter the phase 1 clinical trial land as opposed to the wheel of fortune chemo adventure land.   As much as we fake being a doctor, a clinical trial has it’s own language and it helps that my oncologist can speak that language as he has performed countless trials and recently presented results at ASCO in Chicago. So, his involvement was not only necessary but critical. From the moment my scan was done, he was involved so much that he even began to converse with me via text and email with a furious pace that the urgency was felt unlike ever before. He also had his usual sense of calm and reassurance that this opportunity was one that I couldn’t miss. We are again in a different phase that I could never have imagined. I cannot be worried or skeptical or even be upset because this is what I have to deal with. I have to accept what it is for the moment. Is it ideal? Nope.
So, the unfortunate thing of the trial is that it is in Santa Monica which is like Laguna Beach in the summer for parking. After driving 2 hours, then we have the lucky time of finding a spot with a meter for more than 1 hour as we all know that any doc visit can be 2 to 4 hours. We haven’t fully evaluated the entire facility. I have been going to UCLA Westwood for over 4 years, so it is my “home away from home”. Santa Monica is the land of clinical trials and many are phase 1 which does mean for many more than being  a guinea pig. I was one of the few walking into the office. Many had walkers and many had wheelchairs. These faces were beyond anything I have ever seen at chemo. There were some with their own oxygen and many bald women with sunken faces. I tried to ignore the images and ask about important things like where do you get food here. I guess it was a strange question given the audience in this closet. You see if you are on a phase 1 trial, then they need to measure your blood almost every hour for 9 hours. The positive is that this closet has full bright open windows and I heard you can see the ocean.  Another positive is that despite the weekly visits to Santa Monica (we think for only 5 weeks), the drugs are pills. I am queen of managing side effects, so I plan to do the same here to have the FREEDOM from the IV. All in all between my face injury and the day at Santa Monica I am wiped out. Last positive is that until these pills are started, my blood is in the somewhat safe zone. I referred to my blood counts as rock star counts to the clinical trial doc and I think (I know) he thought I was crazy. Hey, once you have hit the zero zone of having no ANC to fight infection, you learn to appreciate the upswing even if it isn’t in the normal range.
I am making the most of each day and always finding my sunshine. I am so thankful to be out of my isolation running into some smiling faces that I have missed seeing for too long! Make the most of your day…summer is almost here, enjoy the late nights full of light!