Clinical Trial Risks & Side Effects

Okay, part of this is so T.M.I., but we need prayer people. So you have been warned.

Roger received a sixteen page document last Friday from MD Anderson regarding the clinical trial. It consisted of the informed consent and authorization to be a participant in research, a description of the research, a description of the study, potential benefits, alternative procedures or treatment and all the signature pages. Seven of the sixteen pages just covered the risks, side effects and discomforts to the participant of the clinical trial. Roger told me about one particular risk when he got home Friday which threw me for a loop for a bit. Then I sat down and actually read through the whole document. As I was reading through the pages and pages of risks and side effects and stating them out loud as I came across really “interesting” ones, I actually said to Roger, “Have you read this? And how do you feel about all of these?” There were definitely some scary ones.

But one threw us off the most. It was the risk Roger told me about when he got home from work. I kind of went off the deep end for a little bit. You see Roger and I have been praying since last year, okay, me more than Roger, about me getting on board with having a baby. Roger has been more ready than me since he had his first craniotomy in 2006. After he went through paralysis, living in a rehabilitation hospital to learn to walk and function normally again then 30 days of radiation, he told me he thought he wanted to have a kid and did not want to miss out on that experience. We had always felt like God had used us for many things and when it came to having children if God wanted to use us that way he would make it happen and we were fine with that. We both had not felt the passion yet to have children so we both agreed if we had kids we did and if we didn’t have kids we didn’t. No biggie until he shared this with me. So I told him at the time, “When you are really ready, let me know.” A few years pass and we are both finally back in Texas and decide to build a house. One month after moving in, Roger looks over at me and says he thinks he’s really ready now. And the praying began for me to get on board with that. Obviously more praying by me of course. I read a couple pregnancy/childbirth books last summer. And this past February we met with a midwife. That’s when I felt a tiny bit excited about the process. And since then have been praying for God’s direction on timing, etc. We thought we had a plan of me getting off birth control in June, watching for signs of ovulation for a month to make sure my body was all ready to go and begin the trying in August. Then at the end of February we found out about the questionable MRI results. We began to pray about and deal with that and also asked God to direct our plans for pregnancy. We didn’t know what we should do: go with our plan, start right away or put it all on hold. There were so many factors of Roger’s yet unknown treatment affecting what we should do. Was it tumor growing back and would he have surgery and be paralyzed permanently or worse coma or death? Would he have to have radiation or chemotherapy after surgery or in place of surgery that could affect his fertility? Or was it radiation necrosis and what the heck do you do with that? These are the wonderful things you get to think about and discuss with your spouse when you have cancer. Twice.

We knew we couldn’t make any decisions until after we went to MD Anderson. After we met with the neurosurgeon at MD Anderson in May, we thought our only option was surgery and we still couldn’t make a decision until we met with the neuro-oncologist. The Thursday before we were scheduled to meet him, we were hosting our weekly neighborhood dinner at our house. Roger and I were standing in the kitchen prepping for grilling pizzas with 10-12 of our favorite people, talking about anything and everything. And Roger says to me, “Why are we waiting? Why don’t we just start trying now?” So I said okay. I was already at the end of my birth control packet and would just not start the next one. The following Tuesday we meet with his neuro-oncologist who gives us three more possible options before surgery. So we think great, we have time. Thank goodness we started now. I specifically asked him will the drugs in the clinical trials affect Roger’s fertility and he says basically it could and we should look into banking some sperm. We had already discussed this option but were thinking we had plenty of time and could even keep trying while he was doing the clinical trial. Roger took the blood tests required for it the week before we went to see the neuro-oncologist just so that part of it was done.

Then Friday we get this sixteen page document and it clearly states at the end of the risks, side effects and discomforts paragraphs in its own little section that not only should he not father a child while on the study but he should not father a child for six months after the last dose of the study drugs and must use birth control. If his tumor responds to the study drugs he could be on the study for up to two years. What? I just got on board with having a baby and this happens?! The acceptable forms of birth control are birth control pills and/or condoms. Great, I just got off birth control pills. And if your partner becomes pregnant you must tell the doctors right away. Nice. There goes our chance of trying while he’s on the study and gives us about a month and a half at the most to try to get pregnant naturally. If we don’t conceive before he starts the study, he’s got to bank some sperm and then we can start the process of conceiving via artificial insemination or invitro fertilization. Two things I never thought I would have to do. Neither fun nor cheap. At this point I’m thinking I have to get pregnant before he starts the study because I don’t want to take the chance of getting pregnant while he’s on it for fear of what it would do to the baby. So for Roger’s sake, we better get pregnant before because I don’t think I want to have sex while he’s on the study if I’m not already pregnant. Poor Roger. So we are asking for prayer for us to conceive before he starts the study, for protection from all the risks, side effects and discomforts, for peace and strength to continue to make it through this, and that we seek God and glorify Him in everything.

Thank you, Holly.

Possible Clinical Trial

If you have not read our last blog, take a look at it now before you read any further or you might be a bit lost. You can find it here. Holly and I went over our options again yesterday and think we know what we’d like to do as long as Dr. Lang is in agreement. So after that, we set out to Minute Maid Park to watch the Houston Astros take on the Washington Nationals. The beginning of the game was a little boring, but the end was fantastic. Bottom of the 9th, 2 outs, 2 men on base and Astros are down with a score of 6-7. We thought all hope was lost, but then Lance Berkman singles to left and two runs come in to win the game. It was pretty cool… literally too! They closed the roof and turned on the A/C, so it was actually pleasant to be there. We thought we were going to sweat like crazy in the humid evening air, but it turned out to be a great evening after all.

Today we were scheduled to see Dr. Lang, my Neurologist, at 2:45pm; but we got a call yesterday asking if we’d be interesting in moving the appt earlier so that we could leave town earlier and we gladly said yes. We got there at 11:30am and finally saw him at 12:30pm. It would have been sooner, but their paging system was down and they had a tough time letting him know we were ready. It’s okay though… I had fun lounging on his recliner in his exam room and playing with the tools they use to show things to patients… my favorite was the brain I could take apart and put together and wouldn’t you know it, he walked in just as I got it apart. I put it together again though pretty fast. Seemed kinda easy; just saying.

Anyway, he said that he had spoken to Dr. Conrad, my oncologist, regarding the trials and explained each one to us. He agreed that the Lapatinib and Temozolomide trial is worth trying. The Delta-24 trial is really only for people that have a grade 3 ependymoma. They don’t know if my tumor is now a grade 3 and the only way to find out is to do a biopsy by cracking me open. But if they are already in there they might as well remove it, so it is a catch-22. There are some other factors for that trial that make it a not so great fit for me, so for now, that one is off the table. The last trial, 744, he didn’t know about, so that too is off the table for now. He feels that in the end, the tumor will have to be surgically resected (removed), but since it is so slow growing, the first trial is worth a shot.

So that was it. Decision made. They notified Dr. Conrad that we are interested in the Lapatinib and Temozolomide trial and we should be hearing back from them soon. Apparently we will have to go back to MDACC again to again meet with Dr. Conrad to talk about the trial and all the specifics behind it. I am hoping it is as soon as next week. If we start the trial in the next weeks, at the end of the two rounds of the trial, if no progress is seen and the tumor needs to be resected, it will most likely happen no earlier than August 2010. This will allow us to make all our trips we scheduled this summer! I might feel like crap, but we’ll get to be with friends and family, which will be a huge blessing.

A few last notes… To be sure that this tumor was an ependymoma, MDACC wanted some slices of the tumor sent to them from Washington, DC. I put in the requests to the DoD in DC and MDACC got them, examined the slides and agreed that the tumor was an ependymoma, grade 2. Also, the MRI from yesterday revealed that the tumor has grown a bit more, just 1-2mm in three months, which is slow.

I'll let you know when we have anymore news. Thanks for the prayers and support.

-Roger

Non-Surgical Options??

We had an interesting visit today at MD Anderson! We started early with an MRI, blood tests and then moved on to see my Neuro-Oncologist, Dr. Conrad. He already looked at my MRIs from this morning and told us that in his opinion, the growth was recurring tumor growth, not radiation necrosis. We went over the new images and it appears that the tumor has grown an additional 1-2mm since February 2010, which is very slow. With that in mind, he told us that we have the luxury of time, and with that, several options. First of all, surgery is always an option. But there are a few clinical trials I may be a candidate for.

We discussed the surgery again and Holly brought up the blood vessel that goes right through the tumor. Dr. Conrad said that Dr. Lang (my neurosurgeon) is very patient and again gave me a warm fuzzy that he is, in fact, a badass. Dr. Conrad said Dr. Lang is very patient and would do everything possible to avoid cutting the vessel out. But since the tumor is taking it sweet time and I’m healthy he suggested several clinical trials which are very interesting.

First, there is a trial being conducted by the Collaborative Ependymoma Research Network (CERN) Foundation specifically for my type of tumor, which is an ependymoma. Basically I’d be on a chemo drug and a new drug that is a signal inhibitor. It targets this type of tumor and I am a perfect candidate. I’ll have more details on this later, but you can read about it here. This would put any surgery off for several months until they see if this works. I could be on this treatment while in Austin, have blood tests there and only have to return to MDACC every two months for MRIs and would continue with the treatment as long as they see progress. Progress would be the tumor shrinking.

Another trial that I am eligible for is a very interesting one. There are two groups in this trial which has been researched by both of my doctors along with other doctors. In group A, they make a small incision to get to the tumor and inject a virus named Delta-24. It is a modified live virus. Sounds Sci-Fi, eh? They inject the virus directly into the tumor and it kills the tumor cells but leaves brain cells alone. In group B, they insert a catheter into the tumor and leave it there. They then inject the virus and in two weeks they suck the tumor out. Group B should be approved by the FDA for testing in the next few weeks. You can read about Delta-24 here and see both of my docs.

Lastly, there is another drug called 744 that will be out in trials in the near future. He didn’t talk a lot about it, but said it may also be a non-surgery option in another few months. There's a little about it here.

All of this is very interesting and does not mean this is my last hope, but rather because the tumor is so slow growing, is an opportunity to try an alternate treatment before another invasive surgery. Tomorrow morning we meet with Dr. Lang and discuss all these options again with him and maybe make a decision. I am excited to have the opportunity to participate in a trial and possibly make history with a new drug and maybe help save more lives in the future. We’ll have more info tomorrow after the appointment.

Again, thank you all for your prayers. Wow, what a road we have been traveling down. As for Holly and I, we are off to have some fun and are going to catch an Astros game tonight against the Washington Nationals, Can you believe I rooted for the Nats when I was in DC? I guess I felt sorry for them because they were new.

-Roger