Brittany on Cediranib trial Phase 1 in Edmonton

[Bonni Hess]

Hello again Amanda,
I too am worried about Sree and the others who have not updated in too long. My last personal communication with Arch was in early July at which time Sree was still on the Dasatanib Trial with his last scans having been done in June, but she has concerningly not responded to my past two private messages so I am unsure what Sree's current situation is. Hopefully everyone has just been busy Living Life and enjoying summer, but unfortunately ASPS does not take a vacation so continued vigilance with disease monitoring and treatment, research, communication, and sharing of information is vitally important.
Take care dear Amanda and know how deeply appreciated and valued your Board participation and sharing are.
With special caring thoughts and continued Hope,
Bonni

[Bonni Hess]

Dear ASPS Community Friends,
With the University of Washington radiation oncologist's very relieving and joyous words, "Congratulations are in order!", we received the very good results of Brittany's Friday's three month brain and spinal MRI's which very thankfully showed no new brain or spinal mets and no evidence of Brittany's previously Gamma Knifed brain mets . Based on Brittany's continued brain and spine stability,the radiation oncologist keeps suggesting that we extend Brittany's brain and spine MRI schedule from three months to every four to five months. However, based on Brittany's history of brain mets, knowing the unpredictability of this disease, painfully aware of the documented possibility of developing resistance to the Cediranib followed by rapid rebound and aggressive disease progression, and knowing the critical importance of diagnosing brain mets at the smallest possible size for the best chance of successful treatment, we feel that it is necessary for Brittany to continue to have brain and spine MRI's every three months. Brittany's next scans and results appointment will be her 30 month Cediranib Trial status chest/abdominal/pelvic CT scans in Edmonton on November 3rd and 4th for which we are increasingly nervous as always, but are holding VERY tight to Hope for good news results which show continued stable disease with no new tumors. I will update the Board with the scan results as soon as possible after we receive them. In the meantime, please take care everyone, have a beautiful October, know that my special thoughts and healing wishes are with all of you, and keep in touch with the Board as you are able.
With special caring thoughts and continued Hope,
Bonni

[Olga]

Bonni - that's awesome. Could you please make a separate post into the brain mets area this new info about the complete response of the ASPS brain metastases to the Gamma Knife - no evidence of Brittany's previously Gamma Knifed brain mets now. (with the sizes pre- and post procedure - how it looked like and how long it took to dissolve, at least approx).
Thanks,
Olga.

[Amanda]

YAY!!! This is wonderful

I am wondering if there is no sign of ASPS how can it rebound?
I hope it cant!!!

[Bonni Hess]

Thank you dear Olga and Amanda for sharing our great relief and joy with your special caring and kindness. Olga, I will post the information in the brain mets topic when we return Home and I can access our file and notebook with all of the information that you requested. Regarding your question Amanda, although all of the targeted mets in Brittany's abdomen ( pancreas, duodenum, spleen, and small bowel intususception) and the Gamma Knifed brain mets are no longer visible, several spots remain visible in Brittany's lungs, but Dr. Sawyer thinks that they are probably necrotic scar tissue since they have not changed during the 28 months of Brittany's Clinical Trial treatment. Also, Dr. Sawyer said that Brittany is "probably macroscopically cancer free, but not microscopically", so heartbreakingly her disease can probably rebound if/when she develops resistance to the Cediranib and discontinues the medication. For now, we move forward holding VERY tight to Hope that the Cediranib will continue to stabilize the progression of Brittany's disease with a long term sustained response until a permanent cure can be found.
Take care my friends and know that my most caring thoughts and best wishes are with you on our continued shared ASPS journey.
With warm hugs and deepest gratitude for your special caring, and with continued Hope,
Bonni

[Amanda]

Hi Bonnie
You said the Onc said " "probably macroscopically cancer free, but not microscopically", OMG this means even if there is a rebound there is a HUGE chance she can do surgeries and be ok!!!
Are there others also like this? An how is she feeling?

[Bonni Hess]

Dear ASPS Community Friends,
This month of Thanksgiving has VERY thankfully brought us much to be grateful for with yesterday's VERY GOOD SCAN RESULTS!! from Brittany's Thursday's 30 month Cediranib Clinical Trial status scans in Edmonton which showed continued
"Stable CT appearances" and "No new findings". We continue to be immensely grateful for the 30 months of disease stability and significant tumor shrinkage/disappearance that Cediranib has provided for Brittany, as well as the extremely dedicated and knowledgeable care and special caring of her excellent Clinical Trial oncologist Dr. Michael Sawyer.
Brittany continues to have many of the Cediranib side effects that I have previously discussed, the most chronic and debilitating of which are diarrhea, nausea, vomiting, headache, insomnia, and memory problems, but she courageously moves forward with her young Life being as active as possible and Living each day to the fullest with her usual great passion, determination, positive attitude, and bright spirit. She has developed one addditional side effect during the past two months which is increased eye dryness that she successfully treats with prescription re-wetting drops. Her three month monitoring brain and spinal MRI and results appointment are scheduled for January 6th in Seattle, and her 32 month Clinical Trial status scans and results appointment in Edmonton will be scheduled for January 9th and 10th, 2012. As always, I will post an update on the scan results as soon as possible after we receive them. We now move forward into a new year on this challenging ten years and three months ASPS journey with much happiness and continued great Hope in our hearts, but also continuing our aggressive and relentless search, research, and networking with other ASPS patients/families for possible alternative treatments in the heartbreaking event that Brittany develops resistance to the Cediranib and experiences rebound and disease progression.
Please take care everyone, have a very beautiful and bountifully blessed Holiday season, keep in touch with updating this Board as you are able, and know that you are all held very close in my heart and my most caring thoughts.
With special caring, healing wishes for everyone, and continued Hope,
Bonni

[Bonni Hess]

Dear ASPS Community Friends,
Our Hess family begins this New Year 2012 with immense joy and strengthened Hope following the VERY GOOD!! scan results of Brittany's Friday, January 6th 3 month brain and spinal MRI's in Seattle and her Tuesday, January 10th 33 month Clinical Trial
chest/abdominal/pelvic CT's in Edmonton, Alberta, all of which thankfully showed NO NEW TUMORS!! and CONTINUED STABLE DISEASE!! Brittany's radiation oncologist happily described Brittany's brain as looking "pristine!" on the MRI
Heartbreakingly, Brittany continues to suffer with severe nausea and vomiting side effects from the Cediranib which caused her to be hospitalized for five days to receive intravenous re-hydration and anti-nausea meds the week before Christmas, and to have a couple of vomiting episodes in Edmonton and on her return flight to Seattle last night
As we celebrate the special happiness and Hope of a bright New Year and Brittany's WONDERFUL!! scan results, we continue to be painfully aware of the possibility that Brittany may devastatingly develop resistance to the Cediranib at any time, especially since she is to our knowledge the ASPS patient with the longest sustained Cediranib response. There is now an additional concern based on information from AstraZeneca which was provided to us by the Clinical Trial staff in Edmonton. This is critically important and extremely troubling information which all ASPS patients who are currrently receiving Cediranib or who are/were considering Cediranib treatment need to be aware of! The following is an excerpt from the written information which we received:

Further development of cediranib has been stopped
AstraZeneca (the Company responsible for making cediranib) has stopped developing this drug as a possible treatment for cancer. This decision follows cediranib's lack of clinically meaningful benefit in a number of trials looking at three different types of cancer: Colorectal Cancer (bowel cancer), Recurrent Glioblastoma ( a type of brain cancer), and most recently Non Small Cell Lung Cancer (lung cancer). In a carefully manged way all trials are being closed down. AstraZeneca remains committed to supplying cediranib to all existing trial patients who are currently gaining benefit. AstraZeneca has also agreed to supply drug to new patients to the end of 2012, or until the last patient entered completes the study period, whichever is sooner.

Apparently the fact that some ASPS patients have had a successful and sustained response to Cediranib is not significant enough for AstraZeneca to continue investing in this medication because there are not enough ASPS patients to make it financially profitable for the company to continue production. Thankfully Brittany will apparently be allowed to continue receiving Cediranib as long as she is having a positive response to it, but if she needs to take a break from the medication due to toxic buildup from long term use, or if she heartbreakingly develops resistance to it and then at some point wants to try it again if her disease is able to be stabilized on another TKI, it will devastatingly not be available. If any of you other ASPS Community patients were considering Cediranib as a systemic treatment sometime in the future it will apparently now no longer be available to you either in Clinical Trial or as an approved prescribed drug. I don't know if there is any way that this decision can be appealed and reversed, but it is tragic for those current and future ASPS patients who may have benefited from this promising new medication. Perhaps we as an organization can get involved in appealing this decision.
Please take care everyone and keep in touch with the Board as you are able.
With a heart filled with special joy and deepest gratitude for Brittany's good scan results, great concern and sorrow regarding AstraZeneca's decision to discontinue Cediranib, Healthy and Happy New Year's best wishes and deepest caring for everyone in our ASPS Community, and continued Hope,
Bonni

[Olga]

Bonni, I am extremely happy with Brittany results, this drug def. saved her life even if for now. Side effect though are tough and obviously the strong drug like this can not be taken indefinitely.

Thank you also for sharing this very worrisome news about Cediranib being discontinued by Astra Zeneca. I have heard before that it happens when the drug is beneficial only for a rare diseases but not for the more mass ones, they do not pursue it as the charges to get it approved with FDA are very high. I am also wondering what are the regulations about the drugs that did not get approved - are they still protected by the patent law and therefore other companies can not pursue them? The bottom line is that ced. trials are closing soon and if anyone is considering it, take the time line into the variables.

[Katrinauk]

I had some trouble here in England with getting Cediranib, as they had told me that there were some production issues and decisions to be made. A month later they reopened the cediranib trial, and I was able to take part in the trial, with the understanding that cediranib will only be available until 2013. I assumed that was just in England. I must talk to prof. Judson about this, as he's the man to go to about this trial here. I think its disgusting that people with rarer diseases are just a number to them. Instead of looking at the bigger picture, and the fact they are saving peoples lives. Or at least prolonging them.

[Bonni Hess]

Dear ASPS Community Friends,
On this past Friday, March 9th, which was the beginning of the one month countdown to Brittany's celebratory April 9th HAPPY 30TH BIRTHDAY , it was with enormous joy and immense relief that we received the WONDERFUL!! early birthday gift of continued VERY GOOD SCAN RESULTS!! at her Clinical Trial scan results appointment in Edmonton. Brittany has thankfully now had 34 and a half months of disease stability with no new tumors!! , and to our knowledge, is the ASPS patient and possibly any type of cancer patient, with the longest sustained Cediranib response in the world. The one other remaining patient on Brittany's Cediranib Trial in Edmonton, who has a different type of cancer, sadly was recently taken off of the Trial due to elevated blood pressure concerns and a retinal bleed which tragically left him partially blind. This is of course very concerning to us since Brittany and this patient had both begun the Trial at about the same time. Because of the known increased risk of hemorrhage and stroke with ant-angiogenic Tyrosine Kinase Inhibitor drugs like Cediranib, we remain very vigilant in closely monitoring any symptoms which Brittany may have. Heartbreakingly, Brittany continues to suffer debilitating side effects from the Cediranib which have recently caused her concerning weight loss due to chronic diarrhea, nausea, and vomiting. She also suffers severe migraine type headaches and extreme fatigue, but still manages to remain as active as possible Living each day with great passion, purpose, her incredible positive attitude, and bright spirit.
Dr. Sawyer was not able to be there for the appointment as he was away at an international conference, but we discussed the very concerning issue of Astra Zeneca's announced discontinuation of the development of Cediranib with the Cross Cancer Institute Phase One Clinical Trial supervisor. She said that Astra Zeneca has said that they will continue to provide the Cediranib medication to Cross Cancer Institute for responding patients as long as there is availibility of the current supply of Cediranib, but that Cross Cancer Institute has not been given any indication or guarantee of how much medication is available, or how much longer it will be available. What we definitely know is that if Brittany devastatingly develops progression and is consequently taken off of the Trial and Cediranib, the Cross Cancer Institute Cediranib Trial will be permanently closed since she is the last patient on it. Our previous discussions with Dr. Sawyer had been that if/when Brittany did develop resistance to the Cediranib and was taken off of the Trial, that she could possibly try another TKI medication like Pazopanib or Sutent, Hopefully re-establish disease stability, and then return to Cediranib which has thus far been so successful for her, but with Astra Zeneca's devastating decision this option may now not be a possibility unless another pharmaceutical company or medical research facility continues the development of Cediranib. We will continue our efforts to prevent Cediranib and the Hope that it has provided to the ASPS patient community from being taken from us, and I urge everyone on this Board to do the same.
Take care everyone, have a beautiful Springtime , and keep in touch with this Board as you are able.
With a heart filled with the great joy and relief of Brittany's very good scan results, and with special caring thoughts for everyone and continued Hope,
Bonni

[Johannes]

Hi Bonni,

Thanks for sharing these great news with us! Bravo!

Regarding Cediranib, I think we should of course be concerned, but don't forget that there is a chance that its development might be pursued (at least this is what we have been told).

Take care,
Johannes

[Bonni Hess]

Hi Johannes,
Thank you for sharing the good news of Brittany's good scan results with your thoughtful and joyful response which means so much .
Regarding Astra Zeneca's very troublesome announced discontinuation of the development and production of Cediranib, has this issue been specifically discussed with Elisa and you by the Clinical Trial staff at NIH, and if so, what have you been told about their possible plans to obtain the intellectual property of Cediranib and continue development of it based on the outcome of their Clinical Trials with the drug? Also, have you been given a timeline for the availibility of the current supply of Cediranib? This is certainly an issue which will need to be closely followed.
With special caring thoughts and continued Hope,
Bonni

[Johannes]

Hello Bonni,

No, they haven't told us anything specific. Only that if ever the NIH runs out of Cediranib while the trials are still ongoing, the NIH could produce more. The ongoing trials should therefore be ok. And if there is a chance that Cediranib could be approved by the FDA, AstraZeneca might then take over the production of Cediranib... So far, this is only unofficial information, but it means that not all doors are already closed for the future development and approval of Cediranib.

I hope this helps a bit,
J

[Bonni Hess]

Thank you for the shared information Johannes. This is indeed very helpful and encouraging .
With special caring thoughts and continued Hope,
Bonni