brisbane asps cederanib trial .. nearly 2 years in.

[RachyB1615]

Hi all
I'm writing for my husband Luke He is nearly 2 years into his cederinab trial in Brisbane Australia. The trial is now closed and he has been forced to take a "holiday/break" from his drug.
He has stage 4 brain mets, lung mets, abdomen and pancreas and adrenal mets, disease is deemed stable. He is 30 and his diagnosis was may 2015.

He has had SRS radiation to brain and brain surgery resection upon his diagnosis and later discovered his primary was in his right hand.

My concerns are many... firstly, the oncologist has forced him to take a two week break (initially) because the drug has caused him to have an inflamed small intestine and also extreme weight loss.
While on this two week break he has gained 8kg and looks well, he had a follow up appointment today where they now want him to take another two weeks off treatment and introduce the drug back to him but at 20mg which is lower than his original 30mg.
We feel like the oncologist is trying to stretch this break out as long as possible but im concerned.

they keep changing the direction of treatment/length of break every time we see them there is a curve ball and it all feels like it is un known territory for the oncologist let alone us. .
They can't give us a plan on when his next scans will be or exact dates he will return to this drug ..

My question is, do any of you have any experience with these breaks from the trial or learnings that may help give me something to prepare for or to work on to support him? We just have no idea what to expect and it would be nice to know or have a heads up on anything we can be pro Active about.
We can't find any of the Cederanib trial guide lines for ourselves to know the rules surrounding these breaks or what terms a patient to be pushed off the trial.
Also they told us the trial is now closed and if he has over a month off trial he will no longer have access to cederanib?
Can anyone shed some light on this for me please? Any information on the way this trial works and its regulations would be much appreciated or any experience personally had with going on and off the trial also?
Kindest
Rachel

[D.ap]

Hello Rachel
My name is Debbie and my husband and I have a son Josh that was diagnosed at the age of 30 years old He is currently 36 1/2 years old.
We've not been a part of clinical trial but we looked at the possibity of going on one multiple times .
I so sorry to hear of what must be such a scary twist in a long journey , but short 2 years of your husbands diagnose of Alveolar soft part sarcoma .

It looks like you are part of a double blind / 2 arm,phase 2 trial ? Or could you link us to the trial?

https://anzctr.org.au/Trial/Registratio ... 2000020886

Which , if I understand it , patients are given a placebo in
1 arm and cedirinib in the other arm. The patient initial med until progression, then changes to second med . If and when the second med appears to stop working, with most trials the targeted tumor needs to show 20% growth?

With it being labeled double blind , neither the trial doctors or the patient are made aware of which drug or placebo they are taking .

It sounds like your husbands hand tumor was not
removed ?

If they are talking about dose reduction , I would venture to say that you will remain on the trial . And especially if there hasn't been a significant progression of tumors , more than 20% is a standard receist .

Regardless , it sounds as though they are feeling a break is is needed to help him regain his strength and regain health of the colitis like issue ?
Was that mentioned to of become a issue with staying in the trial because this issue?
If you have a primary oncologist, he or she should help you get answers.

Bonni and Jim Hess , here on the forum, have a daughter Brittany , whose been on cedirinib for several years ,and I sure will respond when our morning comes.
Until then , please be assured that we are all here to help or be a good listening ear .
Love Debbie

[D.ap]

Bonni's and Jim Hess's daughters progress

http://www.cureasps.org/forum/viewtopic.php?f=45&t=400
If you go to link , you can personnel messsge (PM)
Bonni questions

[D.ap]

How big are the adrenal tumor and pancreas tumor?
When was last lower pelvic scan performed?

If the trial has closed then the doctors will be prescribing your husband cedirinib it sounds like?

I'd request a last scan copy and hook up with a sarcoma doctor just as a backup, if you haven't already done that?

Damian and Kat are from Australia, and maybe could suggest someone in the Brisbane area, if you don't have a doctor to talk to about your husbands current status.
They have a daughter who is doing well.

http://cureasps.org/forum/viewtopic.php ... lit=annika

[Olga]

Hi Rachel,
First of all welcome here. We have people participating in the cediranib trial, and we have a patient participating after the trial is closed.
I am not sure what are the rules in Australia re. clinical trials, but here in North Am (US and Canada), if the trial is closed but the patient is stable or responding to the drug, it has to be provided to that patient. There might be a problem with the drug availability but it is not your problem, just something to keep in mind and not let them to stop based on that.
Our fellow ASPS patient Brittany Hess, the longer participating person in the world on this trial, had numerous occasions of the toxicity build up and they had the dose lowered and temporarily suspended but she did not have any long periods off drug more than few days if I remember correctly. IV fluids would be given for few days when the toxicity build up occurred and it helped.
My so is 31 now and his pattern of metastasis is close to the one of your husband, he had numerous lung mets first, brain met next, then 3 adrenal mets then the pancreatic met. All were resected or cryoablated except some number of the small lung mets that we are watching and cryoablating as they get bigger. But he had these mets diagnosed during the course of the years with ASPS so we had an advantage of the time between the surgeries/cryoablation, like 1-2 episodes per a year.
There is some advantage of getting the drug off trial after it closed as the rules might be not that strict anymore and if there are some mets that not responding (as they keep mutating and can develop the clone that would not respond to cediranib anymore), then being off trial he can have these resected or cryo/RFA ablated without being kicked off the trial.
Can you please find his clinical trial number or rules online.

[D.ap]

My question is, do any of you have any experience with these breaks from the trial or learnings that may help give me something to prepare for or to work on to support him? We just have no idea what to expect and it would be nice to know or have a heads up on anything we can be pro Active about.

Each trial is run alittle differently
1. Make an appointment with the trial doctor if possible. Anyone that can give you answers to your questions. ask the question, is my husband going to be eligible to go back on cedirinib with the trial?..
Can we get it through compassionate use?

The trial folks need to make time to answer your questions-having you both worrying is not good medicine for either of you.

2. When youv'e gotten your appointment setup,
you both need to take time and enjoy the time off and do some funs things for yourselves.

Hope this helps

[Bonni Hess]

Dear Rachel,
I am so sorry for your husband Luke's ASPS diagnosis and his disseminated disease with widespread mets. I am grateful though that you found your way to this Web site and that you have reached out for information and support. I am grateful too that Luke's almost two years of Cediranib treatment seems to have stabilized the progression of his disease, but am perplexed about his doctors forcing him to take a "holiday/ break" from his Cediranib treatment since abruptly discontinuing the drug for an extended amount of time can possibly cause rebound and aggressive disease progression. Our daughter Brittany, who has now been on her Cediranib Clinical Trial for 8 years and two months with long term sustained disease stability and macroscopically complete disappearance of her innumerous and widely disseminated mets, has never been required to take a "holiday/break" from the drug. Within the first couple of months of her beginning the Trial in 2009, because of the risk of dangerous hemorrhage with Cediranib, Brittany did discontinue the drug for several days before and following outpatient resection of a superficial abdominal met which her very knowledgeable Clinical Trial oncologist felt was interfering with the effectiveness of the Cediranib. Also, when Brittany had severe vomiting episodes from the side effects of the Cediranib, she would periodically discontinue the Cediranib during her couple of days of emergency hospitalization and re-hydration/anti nausea meds IV treatment, but now that she receives preventative bi-monthly outpatient IV re-hydration the severe vomiting episodes and emergency hospitalization have thankfully been resolved and alleviated. It is very important and appropriate that you discuss your concerns and questions about the forced "holiday/break" with Luke's doctors, and that you find out the status of Luke's participation in the Trial and if he is currently on a Trial or receiving the drug Off Trial. The action of Luke's doctors does not seem to follow any Clinical Trial protocol that I am personally aware of as there are usually very strict rules regarding discontinuation of the drug. I echo Debbie's question about whether or not Luke's primary tumor in his hand has been removed. If not, I think that it is critically important for him to have the primary tumor removed if possible because experience has shown that the presence of the primary tumor can interfere with the effectiveness of systemic treatments such as Cediranib. Have any of Luke's multiple lung, abdominal, pancreas, and adrenal mets shown any shrinkage/disappearance during the past two years of his Cediranib treatment? Luke and you definitely have a right to receive more information from the doctors regarding Luke's Cediranib treatment status, scan schedule, etc. and I strongly encourage you to take a very pro-active approach in demanding answers to your many legitimate questions. Please keep in touch with the Board and update us on the outcome of your discussion with the doctors regarding these critically important questions.
Sharing your concern with special caring thoughts, healing wishes, and continued Hope,
Bonni Hess, mother of now 35 year old Brittany diagnosed almost 16 years ago at age 19 in July 2001

[jcs2007]

Welcome to the board, I was wondering if the primary tumor was removed from the hand? While my son was on a clinical trial we were never asked to take a break either so hope you get some answers regarding that decision. Best wishes!