Cure Alveolar Soft Part Sarcoma International (iCureASPS)

Dear everyone:

As of February 22nd, I am now part ofthe Cediranib phase 2 trial at the NIH/NCI in Bethesda, Maryland.

I started my first cycle on the 22nd, and have now taken the drug for only three days.

I do have some bad news to share, It seems like there is a abnormal growth by my liver. After doing all the testing needed to get in the trial, Dr. Kummar said that they had found a spot that lighted up on the pet scan and my CT show something too. She told me that they will follow this new "spot or thing", but in reality they did not know if it was ASPS or something else.

I asked for a copy of all the tests done and also for the radiologist report on the test; I should get those in about two weeks.

Once I get them I will go over them in a more detail matter and will probably schedule a appointment with Dr. Spunt at St. Judes also for a second opinion on what this "spot or thing" is......

Now back to the trial, so far everything is okay with the drug but then its only been three days. My blood pressure was too high today. Because of that I had to start my high blood pressure medicine.

Yesterday, I did experience some stomach problems and I was in the airplane coming home, let me tell you it was not a good thing

After that episode, I have pretty much been okay. I will try to update every now and then and will let everyone know about the progress. Also, in 8 weeks we will be doing all the tests again to see how this treatment is working.

I am really optimistic about this and hope-pray that this drug will help me with the Lung tumors and the new "Spot or Thing".

Sincerely;
Mario Ernesto Arevalo Melendez

P.S.
I now have multiple lung tumors in each lung, they are no longer in the single digit scenerio. This was bad news but I was expecting this.

Mario, thank you so much for opening this topic for your specific experience with cediranib. Good luck with the drug. Be very vigilant re. this new liver growth, if it turns to be a liver met, then ask the clinical trial doctor if you are allowed to have it ablated being on this trial, if this thing is not an index lesion, they may allow it and you will not risk missing the chance to ablate (RFA) it while still very small, in an optimal size to perform this procedure with the high rate of success. RFA is successfully used at St.Jude so they are more then qualified to do that if the trial allows.

Dear Mario,
Thank you for your very informative update and for sharing the good news that you have been accepted into the NIH Cediranib Clinical Trial. I am very Hopeful that you will tolerate the Cediranib with minimum side effects and that you will have a very successful response to the treatment. I am so sorry about the "abnormal growth" near your liver and also the increased number of lung mets. Since Brittany also experienced rapid increased metastatic spread and growth following her ARQ-197 treatment, I continue to wonder if the ARQ-197 actually accelerated the progression of the disease. At the very least, it heartbreakingly did not seem to prevent disease progression for either Brittany or you. I strongly agree with Olga's advice regarding the need to be very vigilant about obtaining a more definitive diagnosis for the spot near your liver, and if it is an ASPS met, pursuing RFA treatment as soon as possible if the NIH Clinical Trial will allow you to do so. If it is an ASPS met, and if it is treatable with RFA, I don't think that you should wait to see if the Cediranib will shrink it since, as Olga said, RFA has a high rate of success for liver mets if they are small. This is definitely something which you will need to discuss with the Clinical Trial oncologist once a definitive diagnosis of the growth is made. In the meantime, please take care, know that my very best wishes and greatest Hope for treatment success and healing are with you, and keep the Board updated as you are able.
With special caring thoughts and continued Hope,
Bonni

Dear Mario,

We were also there at the NIH on the 22nd for screening, hope to meet you sometime in the coming weeks.
I hope the protocol will allow taking a break if required for the RFA procedure. You might want to check that already.

All the best.

Arch

Matt was also there on Feb 22nd. You guys should all get together to chat on March 8th.....

Sure Wendik. I am sending you a private message with Sree's contact phone numbers, he will be very happy to meet Matt and Mario on March 8th. His appointment is at 9:00am.

Dear Everyone:

It's now been officially a full month since I started taking Cediranib. I have had ups and downs but for the most part I been able to tolerate the drug pretty good so far.
I have had many of the side effects that pretty much everyone has experience and maybe some that no one has experience kind of weird. So here is a list of the side effects.

-Diarrhea, now this happens almost everyday and I do not think that it matters whether you eat take out or food made at home. I have try to pinpoint what helps or what doesn't, but have not been successful.
-The first 2 weeks, I had Chronic pain in my whole chest area. Now, you are probably thinking my heart was giving some kind of signal or something like that. But no, It wasn't a heart related problem, it was more like my whole chest area hurt really bad. On the usual scale of 1 to 10, I would say that the pain was somewhere around a 7.
-Joint pain has been pretty bad always, from the start of the trial till now. My knees, wrist, ankles, and elbows hurt pretty bad oh and my feet too. I would rate that pain at 5.
-Vomiting, has not really been a problem at all, I have had only one episode. That day, I had a bad case of going to the bathroom and then chills all over my body and then i threw up twice pretty bad.
-I have pretty much been tired all the time. I am now officially waking up at noon, WHOA pretty bad for work. I am now trying to establish whether I could work from home.
-Now, this is pretty weird I have had a kind of rash on my back and my legs and chest area for about 3 days now. It kind of resembles Acne. They gave me some medicine for now, but the doctors say that they never seen this kind of reaction on anyone. INTERESTING
-My hands and feet get all tingling a lot, sometimes my hands feel really hot too. They say is foot and hand syndrome.
-I have hypertension too, I do not think is that bad because the highest my blood pressure has been is 150/110, for what I have heard there is people on the trial that have hit well over that. So, they got me on medication. I am now a 130/80 usually.
-Liver Enzymes being too high, but its pretty interesting that the only time that the liver enzymes get too high, are when I travel. The only idea that I have is that when I travel I do not take enough fluids. So, I get to the Children's Inn late and just go to sleep without taking any fluids. Then I wake up for my appointment the next day, and I do not drink anything yet. They take the blood labs and next thing I know my liver enzymes are high needles to say next appointment I am drinking plenty of water and I will see if the fluids are the cause of the Liver Enzymes.

Okay, hufff that was a lot, sorry to throw so much at you all; but I am trying to put as much info as possible so that it can help anyone trying this drug.

Now, I have been able to do everything I did before beginning the drug. The only thing that is has kind of hindered is my working schedule.

I also want to apologize to Sree, Arch, Paul and Wendy. I wasn't able to meet them on my 2 weeks appointment due to me having the vomiting episode the night before my appointment. I will try to see if we can all get together next time, I think it would be pretty cool.

I will try to update in a month with my re staging scans. I hope to have really good news. Also yesterday was my birthday, pretty sweet I had some burger with the family and just had a good time. It's now been 3 years since my diagnosis and I am starting year #4 with good hope and blessings.

Well, guys and girls take care and I hope that this info helps.

Sincerely;

Mario E. Arevalo

Mario - this is an amazingly detailed description of your first month experience on cediranib, you'll newer know how many people will read it and prepare themselves to do their best on cediranib, not only people with ASPS but tons of other that will find this board by searching "cediranib" as the drug goes into more clinical trials across other diseases. Thank you for taking your time to contribute to the forum, this is what we all can do to help each other to deal in a most rational way with ASPS.

Dear Mario,
Thank you so much for your very conscientious and detailed update on your Cediranib treatment experience and side effects thus far. This information is very important to all of us who are closely following the Cediranib Clinical Trial and the treatment experiences and results of those ASPS patient who are participating in it. I am sorry for all of the adverse side effects which you have been experiencing, but am grateful that they have not prevented you from doing all of your normal activities with the exception of the fatigue which is negatively impacting your work schedule. Regarding the unusual rash which you have been experiencing on your chest, back, and legs, a couple of months ago Brittany developed a type of rash with raised bumps similar to hives at her previous abdominal Radiofrequency ablation and surgery sites and on her upper arm/shoulder area at the GVAX Vaccine biopsy site. She has been experiencing this type of random rash ever since participating in the failed GVAX Vaccine Clinical Trial at Dana Farber in 2006. She treated her recent rash with topical hydrocortisone cream and it resolved in a few days, so hopefully your rash will do the same. My continued great Hope and best wishes are with you for a very successful response to your Cediranib treatment, and I will be anxiously awaiting your update on the results of your two month status scans in a month. In the meantime, please take care, know how deeply appreciated your faithful sharing of information is, and keep in touch with the Board as you are able.
With special caring thoughts, healing wishes, and continued Hope,
Bonni

Mario,
Keep the faith, it must be really hard to experience all of these side effects without seeing the good results of your scans yet. Jordanne was greatly encouraged once she was able to see the results of her scans and know that the Cediranib seems to be working.
One thing you might try for the diarhea, lactaid. Jordanne's oncologist mentioned that some vegfs cause you to become lactose intollerant. Jordanne is currently off of the Cediranib while she heals from surgery, but prior to that she tried watching her dairy intake and using lactaid. It seemed to improve the diarhea situation. We shall see if that remains true once she starts back in a couple of weeks. With that miserable side effect along with the stomache cramps, it's probably worth a shot.
Stay strong,
Dotty (Jordanne's mom)

Hello again Mario
I just wanted to wish you a Happy belated Birthday with best wishes for a coming year blessed with the gift of healing and renewed good health.
With happy wishes, special caring thoughts, and continued Hope,
Bonni

Dear Everyone:

It's time for the 2 month update news from my Cediranib trial, and let me tell you they are pretty good news. On the 19th of April, I went back to the NIH/NCI and they did all the good tests to see what kind of response I have had so far. The conclusion is that both of the biggest tumors that I have in my lungs and which are being follow by the study, have decrease by a 28% margin. Dr. Kummar was really happy about the results, she said that they cannot call it a PARTIAL RESPONSE YET, because to have a PARTIAL RESPONSE, you must have a 30% decrease. Nevertheless, Dr. Kummar is impressed, as my whole family is too. Also, the smaller tumors in the lungs have all decrease in size.

It is awesome to know that the treatment is actually working. My side effects have kind of change with some going away and some new ones.

SIDE EFFECTS:

- Diarrhea- I get it almost everyday, but the last week I have been taking a fiber powder compound and it has make a remarkable change. You are supposed to take this powder with 8oz of water but I only use 4oz and take it 3 times a day. It helps a lot, now it doesn't mean the Diarrhea goes away, but it helps a lot. I now get Diarrhea less frequently.
-Acid Reflux- This is a new side effect for me, and its not as bad but it has the potential to be. I usually get it at least 2 times a week and they gave me Pepcid AC and it helps.
-Weird Rash in the back- The rash is not going away any time soon, As far as I know I am the only one to have this kind of effect in the NIH/NCI clinical trial. It kind of reflects acne in my back, feels like I am going through puberty again
-Foot and Hand Syndrome- My hand and feet are getting really weird, the skin gets really dry super easy and in my feet, I am starting to get kind of small sores only when I walk too much though. my hands just seems like they are really sensitive. Its not really that bad, but something tells me that it will get worse.
-Fatigue- The fatigue is just getting worse, I am now even afraid to drive sometimes as I just go to sleep without even knowing it. kind of scary, but I have two sister and usually one of them gives me rides to all the places I need to go to.
-Body feeling weak- For some reason, I feel like my whole body is just getting quite weak, I will start doing some sit ups and I might try to do some more exercise see if this helps, but with fatigues and all of the above is really hard to exercise.
-Joint Pain- This has pretty much gone away, just some times I have some pain but on the usual scale is only a 2. So, I think the joint pain has pretty much resolve itself.
-Weight Lose- I have now officially lost about 7 kilos, and its more then likely just going to keep going. I have notice that my appetite is just gone, I mean it just went out the window. I really like food, but now I just don't care much for food.
-Mouth sensitivity- No spicy food period. I also got some sores in my mouth but they come and go away fast, they gave me a mouthwash and that helps.
-Liver enzymes being to High and Protein in urine- I have high liver enzymes almost all the time, but they are not so high that I have to take a break on Cediranib. I also had protein in my urine, but its not too high. Needless to say Dr. Kummar is keeping a watch on both.

Okay, I think thats it. It looks like a lot of side effects and to tell you the truth Cediranib is quite toxic. but so far, I am able to go about my life with just some minor changes. I think that the Diarrhea is the one thing that bugs me the most. Other then that, I am doing good and now I only have to go back to the NIH/NCI once a month, yeap.

In regards to the " we really do not know what it is liver mass", In this last scan; the mass did not grow nor did it shrink any but the radiologist who read the scan says that it looks more like a fatty mass in the liver, yet he did not wanted to make this decision yet as to whether it is a fatty mass or actual disease......... The only thing I can do is wait and see what happens. And about surgery to remove this, I was told no, I could not have surgery and come back to the trial because of the risk of bleeding to death in surgery and the time I would have to be off the treatment to do surgery.

For now I am just feeling good because of the news and hope that in a month, I will be able to give you all even better news. You all take care.

Sincerely;

Mario E. Arevalo

PS thanks Dotty for the info on the lactoid milk, I am going to try it. I have altogether avoid milk or any product with it. but I do miss my everyday glass of milk, I will let you know if it helps. thanks

Dear Mario,
Thank you for your very thoughtful and detailed update with the WONDERFUL!! news of your tumor shrinkage and very encouraging response to the Cediranib treatment. Please know how very happy I and my family are for you and your family, and how deeply grateful we are for your anxiously awaited update on your two month status scan results and your very informative sharing of your treatment side effects thus far. Brittany has experienced most of the side effects that you have with the exception of the increased liver enzymes. She did temporarily have an unexplained rash on her arms and legs at one point during the past year of her Cediranib treatment, but it went away fairly quickly. She also experienced concerning weight loss in the first few months of her treatment, but that has now thankfully stabilized, although she still has very little appetite so she drinks nutritional supplements like Ensure. I am glad that you are trying to exercise despite your fatigue because Dr. Sawyer, Brittany's very knowledgeable Clinical Trial oncologist, has stressed that it is extremely important to try to do weight bearing exercises due to the muscle deterioration and muscle loss caused by Tyrosine Kinase Inhibitors like Cediranib. I Hope that your side effects remain tolerable and manageable, and my very best wishes are with you for continued stabilization of your disease and tumor shrinkage. Please take care Mario, travel safe on your now monthly trips to Maryland, know that I and my family are sharing the great joy and strengthened Hope of your very encouraging scan results, and keep in touch with this Board as you are able.
Reaching out to embrace you with happy hugs, healing wishes, special caring thoughts, and continued Hope,
Bonni

Hi Mario,

We are happy to hear about the 28% shrinkage . I totally understand that the side effects are not easy at all, take care. As Bonni has suggested maybe you should try Ensure, I'm getting it for Sree too. If your thyroid activity is ok, your fatigue might get better with good nutrition.

Take care and keep us updated whenever you find the time.

Arch

Mario,
sure seems like you have more than your share of side affects. Hopefully, some of them will gradually abate. As for the lack of appetite, we have been very concerned about Jordanne's weight loss, she was thin to start with. She saw a nutritionist who gave her a couple of tips that seem to work well. First, never put a full plate in front of you, it's too much pressure. Eat small meals and try to eat something every 2 hours, this helps to relieve some of the nauseau. She seems to be better with this regimen. Also, for diarhea the normal good things to eat go out the window. Try white bread, white rice and no dried fruits which take too much fluid from your body to digest. I'm sure she has more, but these tips are good starters. Jordanne likes chocolate boost as a supplement. Sometimes the supplement becomes your whole meal, but at least it's nutrition and they have some with extra protein.
Good luck and God bless you on the journey!
Dotty