About the study Vaccine For A Cure

 The vaccine is ONT-10 and it is given in combination with varlilumab. Varlilumab (does that sound like a type of yoga pants) is an antibody. The goal is that combination of the two drugs will activate my immune system to fight the cancer. The combination of the two drugs is a new phase 1b study and so far the dose and side effects have not been established. It is an open label study (i.e., I get the drugs that they say I get). There are no placebos or experimental manipulations except for the dosage. We all get the same great deal.

Three days before the start of the study:

Again I reported to the infusion center and this time there was no problem. I had an infusion of a small dose of Cytoxan (cyclophosphamide) to jumpstart the immune system response. It was not like serious chemo at all. I had a bit of nausea but nothing my regular anti-nausea drugs could not take care of. I had no loss of hair or anything drastic. It was given with a premed of Kytril and I drove myself home without a problem.

Three days later I was back at the hospital for day 1 of the trial.

Day 1

I saw the nurse practioner who checked me over and made sure that I was still exercising and eating properly.

I had 4 subcutaneous (under the skin) injections of the vaccine ONT-10 in the abdomen and legs and then vitals checked to make sure I did not have a reaction. My drug reactions are legendary (not a good thing) so a clean bill of health was a huge relief. I then trotted off down to the infusion center to get my varlilumab. The nurse came to do the infusion and I noticed she was wearing chemo gear. She laughed and said that she was just checking to see if I was paying attention because of course I was not getting chemo.

Except for the three tries for a vein, everything went smoothly enough. I had the infusion over 90 minutes and then had to have blood drawn from a different vein (two more sticks) for a pk (pharmacokinetics; how much of the drug is in my body). I was fine and drove myself home.

Day 8 and 15

For the next two weeks, I went and got my ONT-10 injections and then home. Still no side effects at all.

Day 22

The ONT-10 injections happened as usual. After that it was a trip to the infusion center for another dose of varlilumab. This was the same as Day 1. The infusion over 90 minutes and then a pk. Again, there was no need of a premed and no reaction.

Day 29

This was a fun (not) visit. It started off with 18 tubes of blood being drawn. Fortunately, the phlebotomist knew a thing or two and it only took one stick. After that, it was plain sailing. I had the four injections and went home.

I’m half way through the dose loading phase. I really hope it is working. I'm living a normal life. I have no pain and no side effects. I work 40 or more hours a week, exercise two hours a day, bake bread four times a week, read and do all the things wives, mothers and friends do.

 

 

 

 

 

 

Starting a new trial

My clinical trial with MLNo128 finally ended on December 23 with the scans showing disease progression. It was one of those drugs that was too toxic for me at the full dose but not effective enough at a reduced dose. I still have residual side effects even though I have been off the drug for over two months. My nails are still dry and brittle, my tummy trouble is not fully resolved and I itch all over, all night. My back looks like I have a serious case of the kinkies the way I have scratched myself. However, I had a good run in the world of clinical trials and metastases. I was on the drug for 32 weeks before progression and I still exercised for two hours a day, ate my vegan diet, slept as poorly as usual, did chores, watched movies, worked full time, learned something new every day (I am addicted to MOOCs) and was a mother and wife and friend.

I spent a few days in Florida at Islands of Adventure and Universal in Orlando and staying with dear friends on the beach. I went for long walks and ate great food and put my illness in a little box in the back of my mind for a little while.

The problem with clinical trials is there is no wiggle room. A scan scheduled just before holidays means exactly that. There is no postponing to a less-stressful week later and this scan day was a day that one wishes did not exist. Although I hadn’t had any pain, I had some feeling of things weren’t quite normal. Normal of course is a moving target when you have cancer and half of you hopes that this is just a different normal, but the sensible half of you knows that the results of the scan are not going to go your way.

 I had a complete melt-down at the doctor but had pulled up my big girl pants by the time I got home and cheerfully celebrated the holidays with my family, reserving tears and fears for the loneliest small hours of the night. We ate good food and played games and I took my usual thousands of photos while the washout period of four weeks began. It’s very scary to be told that all treatment will stop for four weeks before you can join the next clinical trial.

First stop was a liver biopsy. That was relatively painless and I arranged to donate tissue for research at the same time. Then came the blood work. They had to take so much blood that it had to be done on two different days. The first visit was 12 tubes of blood and a few days later I went back for another 16 tubes, an EKG and urinalysis. I was finally ready to have the infusion.

I got to the infusion center on the appointed day, exactly four weeks after my scan and the research coordinator caught me before I went in. I could not start the trial because my white blood cell count was too low. This has been an endless problem since I had my first round of chemo a decade ago. I was devastated. Not only did it mean I missed the start of the trial but now I had to have the scans repeated because I had missed the four week cut-off since my last scans. So I duly went and had more scans and breathed through the associated anxiety. As you can imagine, four weeks without treatment meant that my scans were not pretty. However, I swallowed hard and prepared myself for the new trial.

First step was I had to get my WBC count up. I did the right things and did what I was told. As insurance, I ran up 48 flights of stairs before my blood was drawn for a WBC count. Ha. The count was higher than it has been in a decade. Now it was way up and I could begin.

 

It's been a while

Clinical trial MLN0128

This update was really difficult to write but it turned out for the best because I ended this trial at exactly the right time to start the immunotherapy one. More on that later. This update is from the last blog to early December when things started to go wrong for me and MLN0128. To tell the truth, things had been going wrong for some time but this was an escalation of disaster.

When people talk about the roller coaster of stage IV, I don’t see it like that. I get the metaphor of the highs and lows but there is no thrill in the rapid decline that precedes the low. I think of it as more like a tsunami that has endless waves that keep pulling you deeper and deeper into destruction and with it are the homes and lives of loved ones destroyed by the pain of losing a mother or daughter or sister. I think this is hardest for the mothers who lose their daughters and are helpless to protect them from the onslaught.

The clinical trial required monthly visits to see the doctor or nurse practitioner and these events were always ones I would really rather miss. Every time I see the appointment reminder on my phone there is a big red “Cancel Appointment” button that I long to click. But I never clicked it and I went every four weeks as required by the clinical trial and would hand back the four pills (carefully counted by the pharmacist) and collect another 30-day supply of 60 pills. I also had a sheet with the exact times I took the pills every day and the glucometer with the readings of the twice-weekly finger prick results.

At my November visit, my drugs were delayed. Apparently, my liver enzymes were elevated. There were a bad few moments. My immediate thought was that liver metastases had progressed to a dangerous level, but the NP reassured me that it was probably “just” a side effect of the drug. An abnormal blood result is a huge palaver. Everything has to be checked against the protocol. It turned out the results were only a level 2 elevation so I was good to go with another month of drugs but needed to have blood drawn in two weeks to check. I am not sure but I think the fact that I had been trying to put some weight back on and consuming about 3000 calories a day might have had something to do with it. I decided to cut down on the 85% dark chocolate.

The doctor visits consume a huge chunk of the day. I had to fast (water only) before the blood draws and that is tough as only a caffeine addict would know.  I always think I should have a flashing light on my car to warn people when I haven’t had my caffeine. I have to leave an hour before the appointments to get there in time and have started to make a flask of green tea for these long days while I wait for the results of blood tests. On this cold November day, I felt like a construction worker sitting in the waiting room and drinking from a thermos cup, huddled in my polar bear hat.

While I was waiting, I talked to another patient who had to come back to get her prescription changed for her opioids because the prescription was for one month and it had only been four weeks since she had picked up her last prescription. She has Stage IV and is in constant pain. I just don’t understand the need for all this bureaucracy. Doctors constantly offer me Ativan and I decline. I never refill my prescription. I just ask for a new one about every 9 months or so, but ¼ of .5mg really works well for mild nausea.

While we were waiting, she told me her very sad story. Her husband was killed in a car crash seven years ago and she still felt her life was bereft of meaning. She and her husband were stopped at a stop street and the oncoming car with bald tires skidded on the icy road right into them. Her husband was killed instantly and she required hospitalization and surgeries. The driver of the car was in the country illegally and had no driver’s license or insurance. He was unhurt.

I went home exhausted and emotionally spent that day but ready to enjoy Thanksgiving break with two of my children who managed to make it home.

I watched one play video games. He has a wonderful way with words and amuses us immensely. He is also very sociable and goes out most evenings.

The other son is more serious. He has a wide general knowledge and it’s fun to ask him about things as you think of them. His ambition is to read the whole of Wikipedia but of course he can’t. He has still made huge inroads and read more than most with a deep understanding. He has an undergraduate science degree and a graduate computer science degree and is rapidly rising in the ranks at Google.

Whenever we have children home we like to go out and eat. I have a few favorites. I don’t make a big deal of whatever is available but some restaurants have nothing that I can eat. A clue is if you see the words deep fried at the top of the menu.

 We love to sit in the hot tub in the evenings and just talk. It’s a communal time where everyone shares what they did and what they hope for. The boys have a beer and conversation is animated.  

The days go so quickly now.

On Thanksgiving Day we went for a 5k run. There were over 8000 people there and it was chaotic. I don’t understand why it is so popular when it is so badly organized. It was thoroughly miserable and definitely tops my worse run experience ever and I have been on some pretty bad ones. It took 45 minutes to actually get to the start because they had no system. The sponsors were United Way which makes me think that if they can’t organize a simple 5k run then what can they organize? They are not on my current list of charities anyway but now they never will be. The highlight was getting home to soak in the hot tub for 20 minutes before I started cooking.

I did go back to have blood checked again two weeks later and everything was back to normal. And so the tide turns and takes a short break before the next wave hits.