Clinical trial or not... that is the question up next.

The protocol for Tim’s chemo lasts until June, 2007. The standard protocol has 16 rounds of the triple whammy with other weeks just having vincristine. Around week 13, radiation will also start and last for five weeks. He’ll have to go to the radiation oncology lab each weekday during those five weeks.

Tim was offered entry into a phase three clinical trial for low risk patients. He is actually on the high end of the low risk category. This trial would modify the protocol to eliminate the last 12 triple whammies and replace them with just the administration of dactinomycin. There are also some breaks in administering the dactinomycin. Both protocols have some breaks on the vincristine.

A phase three clinical trial means that they have already decided that the new protocol is likely to become the recommended one for the future. This trial is to build up patient data to compare survival rates with or without the full 16 rounds. Since the cancer Tim has is rare enough, they are only looking for 650 patients in this trial. A normal phase 3 trial would have several thousand patients. However, rhabdomyosarcoma survival rates have been going up over the last 20 years due in large part to the aggressive treatment protocol. Backing down on that protocol is risky business.

Tim has been weighing the risks of staying in the clinical trial or going with the initially recommended protocol. The third of the chemo drugs, cyclophosphamide if given over the full course of treatment will continue to weaken Tim, has the high potential for causing sterility, and has the late term (after treatment is finished) potential for causing leukemia. Seems strange but also makes sense that these chemo drugs could themselves cause a cancer. Of course, the risk of a recurrence of the original rhabdomyosarcoma is the risk that gets reduced by getting the full 16 cycles of triple whammies which include the cyclophosphamide.

Tim had to decide right at the beginning to enter the trial because he could always leave the trial but could not enter after treatment had started. So we did sign up to enter the trial. The experiment to run would be to see how the triple whammies would affect Tim. Would they pound his blood counts to the ground, make him super tired or keep him out of school? It seems now, that we have gotten better at preparing for the triple whammies and for the follow up care at home over the next few days. So, Tim is really leaning towards exiting the trial and going back to the recommended protocol of all 16 rounds of cyclophosphamide. We have one more round to go before that decision needs to be made final.

It is incredibly difficult of course to make such a decision. If the triple whammies were causing long hospital stays and/or extended recovery times, it would be easier to decide to stay in the trial. Tim is improving each time he goes through the major cycles. So that makes me think he will decide to leave the trial and take on the full set of major cycles.

I hope that his body continues to adjust for the better with the continued administration of the chemo drugs. It seems to be going that way. I think exiting the trial will be the choice Tim makes and of course that is a decision that we will fully support.

--bob

What about high school?

About two weeks ago, we all met with Tim’s teaching staff, counselor and school nurse. This was to recognize Tim as participating as a Section 504 student. This federal law allows some accommodation of his “disability” but doesn’t require the school to provide an individual teaching plan for him. Basically it is to allow some leeway in assignments, class attendance, and test taking so that he can complete his year in high school. I have to say that the teaching staff in this regard is exceptional. The staff took time to meet before school started and worked through a number of ideas. We outlined the kinds of things Tim will face over the next year such as missing every third Friday while being in the hospital. Tim will still have to do the work but perhaps not all the busy work. He may also be allowed to take tests outside of the classroom or at a different time to accommodate the hospital admissions.

So far though, Tim hasn’t had to miss much school. He was already at round 2 of the triple whammy over Labor Day weekend and it just so happens that the Friday he would miss was an in-service day for the staff at school. And Monday of course was a holiday, so he didn’t miss any school. On whammy round 3, he did miss a Friday but had pledged and did in fact get ahead of assignments he knew about so he did not fall behind. Other than, that he hasn’t missed any school due to reduced immune system effects.

He has had to reduce his physical output in marching band. The band practices evenings on Tuesday and Thursday and he has had to miss a Thursday evening because of a hospital admission. He’s also been very tired of course and that means he can’t participate to the physical level he would like. This week he was able to be at both Tuesday and Thursday evening band sessions and at least help out the marching members (he won’t be marching) and play the music from his position in the pit.

Even so, it does take a toll on him to be up what is now late (9:30) for him. He does very well when he can get 10 hours of sleep in a night. The struggle is that he’s at that teenage time when staying up late is the norm and then trying to make it up on the weekend. He really needs to get consistent sleep each day. So we’ll work though the short term marching band schedule and hopefully when that is over this semester, he can get back to a more normal sleep schedule.

Another high school event is homecoming and that is coming up in a few weeks. It is a series of events with the football game on Friday and a dance on Saturday. It would have been the Thursday just prior for the triple whammy but the oncologist was able to slide the time to the following Monday. So Tim will be able to fit in a senior year memory. And he has a date!

So the Monday after homecoming will be the first time Tim will have an extended absence from school of at least two days. We’ll see how it plays out and if he can get ahead of the curve on schoolwork so those two days won’t be a big problem. If he works it like the last triple whammy, he may feel good enough to go in Thursday but we’ll have to see.

--bob

Triple whammies getting better, can it be?

Oh my gosh! Things have really been moving along and I have not updated much here. I'm going to separate things a little to keep the entries manageable.

Triple whammy round 3 went really well. This time, Tim was able to get appropriately hydrated before going to the clinic and even though it took a long time to get admitted, he was "ready to go" for the chemo administration by 9 PM. Quite an improvement over the last time where he had to wait until 11 PM. We also discussed the concept of checking vitals all night long with the nursing staff and that really helped a lot. The only "interruptions" through the night were related to having to go to the bathroom. As a result, Tim was able to get a lot of rest over night and was discharged around 3 PM the next day.

We also asked Tim to try and limit visitors to the hospital and so we didn't have any. A couple of phone calls from friends which was no effort at all. While in the hospital limiting the need to stay alert really does help and we appreciate everyone considering alternate ways of showing their support. It really really helped Tim make a quick recovery.

Staying overnight in the hospital for me is getting easier as well. It's like camping in the living room. Sleeping bag and a pad on the floor works really well. The cots they have in the hospital are actually quite noisy and so they wake Tim up when I move. We just skip them. This time, Tim even slept through the infusion pump alarm. I cheat a little and silence the alarm, then go find the nurse. The oncology floor was completely filled so that made it a little difficult finding someone, but we got it all sorted out.

We're still trying to figure out just how long to stay on the anti-nausea meds. This time, we skipped one more dose than last time. These meds make Tim's stomach feel funny (as he describes it) but they also mask the need to vomit. So it's a trade-off just like a lot of things. We cut off the anti-nausea on Saturday evening and Tim did real well with that.

However, Tim also gets allergies from time to time and right now, sage is very high. So his nose has been running and come Monday he did have to throw up in the morning but felt OK afterwards. And then Thursday morning again.

So, now we've gained some more experience with the triple whammy (vincristine, cyclophosphamide, and dactinomycin) and perhaps it is getting better. I wouldn't recommend it of course but at least we have a better handle on it and our experience is starting to pay off. It is actually getting better.

Keep the prayers coming, they are clearly working!

--bob

Normal week??

Well, it's been about a week since the last post where I reported that Tim was really tired. He's recovered a lot since then and has been in for another round of vincristine this last Thursday. Remarkably, his blood counts are looking pretty good. He has also been feeling a lot better this week and has been able to participate in band events in the evenings.

The Boise area has been experiencing poor air quality with several red alerts issued and stage 1 alerts as well. This has impacted after school events and several day's worth were cancelled. However, we were able to go see Tim and the marching band perform their opening at last Friday's football game halftime. It was well done. Tim doesn't march on the field but plays a tuba sitting in the pit. From where we were in the stands, it sounded really sweet and between Tim and the two marching tubas, that part of the score had an expanded presence. It was really nice to see how the school, and in particular the band instructor have been able to accommodate Tim. He continues to remain enthusiastic and positively focused on school activities.

This week we will meet with the school counselor to discuss classifying Tim as a 504 student. This will recognize his reduced capacity for this year and allow the school to make reasonable accommodations for him. He'll still take the full course load but may not have to complete all the busy work assigned. Perhaps just demonstrate that he knows the material to move on. We'll get more details this Wednesday.

More and different side effects showed up this past week. He has some acne developing (a recognized side effect) but this seems to already be under control with topical over the counter treatment. His voice continues to sound hoarse, the finger tips and toes are tingly and numb, and from time to time balance seems to be an issue.

This coming weekend, Tim and I will take a trip to see his brother at U of I in Moscow, ID. Tim should be on the recovery by then. Blood counts and in particular his white cell counts are supposed to rebound this week. In fact they are supposed to be at their low point right around now. But he got a good report last Thursday and no indication that more tests needed to be done early this week.

Maybe we have some silver lining showing through and his bone marrow is pretty good at taking the hit each time from the chemo.

Could this have been a (new) normal week?

Warp drive off-line... impulse power only

Here we are at the end of the long weekend and it's been a balance of being really tired but wanting to do lots of things. Tim is feeling the effect of the chemo now more deeply than before. He has been very very tired all weekend. Luckily it was a four day weekend so he's had an extra day to recover somewhat before school starts up again on Tuesday.

We were able to take in the women's soccer match on Sunday morning after church. A friend of ours with many connections through school, soccer and music was in town for a tournament. It was fun to watch her and her team play and to do really well even if it was against the Idaho Vandals. She is an extraordinary player and started and played all 90 minutes as a freshman. Tim did OK being able to sit in some umbrella shade. It was a lot of fun to be there.

The stomach came back to normal very quickly and by Sunday morning, Tim decided not to take the last dose of Zofran (anti-nausea). He did fine with that and has been eating well although in smaller portions. He also states that his taste is different now and another curious effect is that he has an enhanced sense of smell for iodine of all things. His voice has also changed, he has what sounds like a sore throat but claims it does not hurt. Perhaps some other side effect. And the tingling that was in his toes is now also in his finger tips.

So now, tired is the name of the game. This is likely the last weekend where the energy can be used for non productive things like "hanging out" and playing xbox. When some effort can be applied it will have to be applied to school work to make sure Tim doesn't fall too far behind. As parents know, this is tricky business even without the added issues around chemo treatment. The discipline will have to built up to get the schoolwork done first and then be able to move on from there.

Some things have already been eliminated well before the energy level dropped. Tim was supposed to be the tuba section leader in marching band but is now not going to carry a tuba around on the field. He'll likely play sitting in a chair to lend the musical part without the march. There aren't many tubas in this marching band anyway - now there are only two who will march. He had a pretty busy school schedule that would have required "zero" hour. Come in one period before everyone else for an additional course. We were able to get that dropped, it wasn't needed to graduate.

Also, soccer in the spring just won't be possible. With the port-a-cath device in his chest, he would not be able to take a direct hit to the spot either by the ball or a player without causing injury. He'll see how else he can support the team by being at games. This team he was going to be on was with a number of players he has played with for many years. At U17, many players drop out and this would have been his last year anyway. So he'll just have to move on to playing soccer for fun in college.

So it'll likely be a long time before we can get back into warp drive, for the moment it'll be impulse power only.

--bob

Triple whammy round two

In a nutshell this visit to the hospital went really well. Tim was quickly back on his feet and without the nausea that accompanied the week one chemo. So perhaps that really was due to the spinal tap and his reaction to that.

The learning from this time was to make sure to drink lots of fluids before being admitted. Tim had to wait until about 9:30 PM for the chemo dose to be delivered because he was not hydrated enough. And then as a result of a low blood pressure reading, he was on the list to have vitals checked every hour throughout the night. That made for not a whole lot of sleep for either me or Tim.

Blood counts were all pretty good. Platelets really rebounded, red cells were on the low end and the white cell mix was not normal but there were enough. The thought is that red cells will continue to be depressed as time goes on so there will likely be a gradual decline in energy level. Two days later for instance, Tim is really feeling the effect and is very tired and it is getting more difficult to simply walk a distance without his cardio system acting like he just ran a mile. We'll have to see how that continues to change over time.

He's also starting to feel more of the mid term effects fo the chemo drugs. His toes are now tingly from the vincristine and he has some balance problems also from the vincristine. Some good news also came last week in that the second opinion of the tumor pathology confirms the embyonal form rather than the alveolar form of the tumor. That would allow him to stay in the clinical trail that would end the triple whammy visits after four rounds. However, Tim is thinking that he's doing pretty good after this round and so is inclined to stay on the agressive chemo for the duration. He'll have to make that decision in the next 6 weeks so he'll have another triple whammy round to go through before that comes up.

He was able to go to a local soccer tournament to watch a game and met up with a bunch of people, distribute some more wrist bands and generally have a good time. It was exhausting but a good time to be outdoors. We'll see if the college women's game tomorrow can be attended or if it's just too much to deal with.

Zofran seems to be doing the trick for the nausea this time, but curiously he has some pretty whicked hiccups going on. This could be another side effect. They seem to last about an hour but then come back an hour or so later. We'll have to monitor any of these curious effects and see if they are just coincidence or if they really are caused by the treatment.

So, all in all a much better hospital admission.

--bob

Support for lost hair

As was somewhat expected, Tim began to lose his hair about 2 weeks after the first round of chemo. All three meds indicate hair loss as a potentail side effect but I think it's pretty much 100% certain with the three drug combo. Anyway, Tim was losing it not in clumps but many many strands when running fingers through his hair. So it was time to shave it off.

New territory of course so we decided to buzz it really short so as not to get the remaining hair stuck under the scalp. Over the next few days most of those little stubbies fell out. But the surprise was that some new hair grew in its place. Not a lot though and the new hair is very light in color. This probably won't stay very long since the week 4 treatment will likely cause those new hairs to fall out.

Tim's cousin felt the need as did myself to get the close buzz cut. The picture on the right is Tim and myself after my haircut. The picture on the left is Tim's cousin John with his new "do". He also sports the wrist band he had made in support of Tim. It's really cool and a number of them have made it out to friends.

Chemo meds are nasty stuff

The protocol Tim is on includes three chemo meds, vincristine, dactinomycin, and cyclophosphamide. These drugs have been around for many years and been used to treat various cancers. By far the nastiest is cyclophosphamide however, he only gets this every three weeks. This is why he has to be admitted to the hospital for at least 24 hours. This drug has the short term effects of causing nausea and bladder lining erosion so lots of IV fluids are administered both before and after administration of the drug. They also administer some counter-agents for nausea and mesna to counter the bladder issues. Cyclophosphamide is an alkylating agent and gets converted into a pair of chemicals by the liver that interfere with the division of cancer cells. Of course it also does the same for normal cells.

Dactinomycin is an anti-tumor antibiotic that Tim also gets once every three weeks. This one also interferes with cancer cell DNA in a different way. Tim hasn't had this one without the other two yet (later stages of the protocol do this), so we're not quite sure of it's individual side effects.

The last one, vincristine Tim gets every week. It is such a small amount and doesn't have short term effects so it is administered in the office. It still requires an access in the port-a-cath but only takes a short "push" of the med (only 2.5cc). This one has some medium term side effects that Tim has experienced. Jaw pain and tingling toes are the ones he has had. And this one also affects the small intestine lining so one has to be on the lookout for changes in regularity.

There is also a med administered to enhance the body's uptake of the drugs. Dexamethasone is used for this. It is a steroid similar to that produced by adrenal glands. Tim gets this every 12 hours along with the anti-nausea med while he's in the hospital.

Since the body gets beat up each time chemo is administered, there is also a regimen of antibiotics to counter the potential for pneumonia, pepcid to keep the stomach happier, senecot for regularity, and salt and baking soda mix for potential mouth sores. Fast growing cells of course are being attacked by the chemo meds and these counter measures are to head some of that off.

--bob