Cure Alveolar Soft Part Sarcoma International (iCureASPS)

Dear ASPS Community Friends,
As per information provided by Jordanne's mother Dotty in her last night's entry on Brittany's Cediranib thread, the NIH Cediranib Trial is apparently temporarily on hold pending an investigation of the adverse effects experienced by some of the Trial patients. Do any of you who are currently participating in the Trial, are planning to participate in the Trial, or anyone else on this Board have any information about this situation? This of course concerns us if the adverse side effects are anything dangerous or Life threatening which we should be aware of in regard to Brittany's ongoing Cediranib treatment. Thank you for any information or input that you can provide about this. Take care everyone and keep in touch with the Board as you are able.
With concern, special caring thoughts and continued Hope,
Bonni

Hello Bonnie,
Have they contacted you about stopping taking the meds she has yet? This is confusing and i will ask my Onc if he knows any thing about this when i see him tomorrow!

Sending hugs and hope that this is just being done by them as precaution <3

Amanda

Hi Bonnie,

my stepmom is the one who spoke to NIH yesterday. They didn't say anything about it being life-threatening and it was only two patients experiencing it so for now I would not worry. They are investigating it this week and should hopefully know more next week. As they let us know what is going on I will for sure let you know right away. In the meantime just keep rejoicing Brittany's successful tumor shrinking I would also love to get together sometime with you and Brittany. She is very inspiring to me as are you to my mother. Now the trial has been put on hold we will not be travelling next week so we will now be more available. Please feel free to call me if you find some time and would like to meet. My number is 360-304-0067 and my moms is 360-402-0132 in case I'm unavailable and you'd like to get in touch with her. Best of luck with more tumor reduction in Brittany

jordanne

We had a start date of 1/11 for Matt's testing at NIH. That was changed to 1/14 as the PI (Dr. Kumar) was still out of the country. On Wednesday they notified us that it would be at least another week because of some adverse effects. Our oncologist called the nurse practicioner working with Dr. Kumar, and she told him that one patient was experiencing extremely debilitating diarrhea, to the point of dehydration and significant weight loss. I guess when Dr. Kumar returns on 1/14 they will re-evaluate things and hopefully get started again. The nurse feels confident that by the end of the month they will be up and running again.

We are incredibly anxious to start as Matt has had no treatment of any kind yet.

If I get any updates, I'll post immediately.

Wendy

Thank you for your very prompt and thoughtful responses, and for your valued input dear Amanda, Jordanne, and Wendy. I don't really think that Brittany's taking the Cediranib medication through the Edmonton Clinical Trial will be affected by the temporary suspension of the NIH Phase 2 Cediranib Clinical Trial, unless Astra Zeneca determines that there are serious risks from the medication and completely withdraws all use of the drug, but I doubt if this will happen because I think that the safety of Cediranib was already determined in the earlier Phase 1 Trials. However, as I told Wendy in a personal message, it is perplexing to me that the NIH Trial would be suspended based on patients having experienced severe diahrrhea, weight loss, and increased liver enzyme levels, because these side effects, among several others, are already well known and documented effects of the medication. Hopefully there are not other more serious side effects that we are thus far unaware of, and whatever the issues and concerns are, they will not prevent continuation of treatment with this promising new drug which has provided so much Hope for us and so many in the ASPS Community. We will be closely following this situation, and anxiously awaiting any updates regarding the status of the Trial and those who are enrolled in it. Brittany will be going to Edmonton next week for her required monthly clinic appointment, blood work, and ECG on Friday, and we will have her ask Dr. Sawyer if he is aware of any new problems or concerns with the drug. In the meantime, please take care everyone and keep the Board updated as you are able.
With special caring thoughts and continued Hope,
Bonni

I think I can provide some encouraging news here. My wife MJ was the first to start the trial at NIH in September - She has been on HOLD with the medication now for three weeks. This is a result of side effects including increased liver enzymes and weight loss. Recently, we received news that levels are normalizing after three weeks off the drug. I do believe this contributed to the current temporary closure of the trial to new participants. I also believe, based upon MJ's recent improvement, the PI should be encouraged and hopefully reopen the trial soon.

Dear Brian,
Thank you for the important shared information and for the encouraging news that the NIH Trial will probably re-open soon. I am so glad that MJ's levels are normalizing, and Hope that she will be able to resume taking the medication soon. Based on Brittany's experiences with three episodes of severe uncontrollable vomiting each about two months apart, we have observed that there seems to be a toxic build-up of the Cediranib beyond which the body can no longer tolerate the medication and needs a short break from it. Hopefully this is one of the things which will be determined through the Clinical Trials, and a different dosage regimen can be established which identifies the optimum period of time that the patient should take the medication before discontinuing taking it for a short time while the toxic build-up dissipates, as well as the amount of time that the patient can stay off of the medication without risking rebound or loss of effectiveness of the Cediranib. Please keep the Board updated as you are able, and know that my continued special thoughts and best wishes are with MJ and your family.
With special caring and continued Hope,
Bonni