Topic: Update on NIH Trial

Hi everyone!

I am so sorry it has been so long since I have posted.....no good excuse. I will do my best to catch you all up on what has been happening.

I believe the last I posted was that my tumors were just starting to grow after a great year on this trial.....last August when I went in for my checkup the team of doctors deemed progression and became urgent to repeat the TIL protocol for me. They explained that my DNA mutates somewhere around 20 times before it turns to cancer and that they had identified a specific T cell of mine that recognized a specific mutation.  I am sure that I am probably not explaining this exactly as they did, but this is how my simple mind understood it. This was discovered after my first treatment. They wanted to retreat me as soon as possible and I was all for it!!!

In September 2013, they removed 3 of the larger tumors from my right lung this time....now I have matching scars on each side:) They harvested the lymphocytes and grew them in the lab again for 3 weeks, specifically growing the cell that is reactive to my tumor.

In October my husband and I returned to NIH for treatment. I felt stronger going into this treatment than the first but I have to admit it was harder this time around.....the week of chemo to suppress my immune system sucked as usual but was tolerable. This time I received 127 BILLION cells back into me with about 90-95% of them being that "special T cell".....compared to the 42 Billion the first time with only about 25% of them being that " special cell". I again only made it through 4 doses of IL2, which hit me harder this time around. IL2 helps to facilitate the cells to be active or something like that, all I know is it gave me some pretty comical hallucinations and sent my creatinine through the roof. It also was harder this time just because of the number of cells infused. It was a huge immune response...which is what makes you feel yucky when you are sick. I made it, and my counts came back enough to go home on November 8th. Recovery was a bit harder this time but within 2 weeks I was up and at it and each day got a little better.

My first checkup was December 5th, 2013....with GREAT results. My liver tumors had shrunk and most of my lung tumors as well....they estimated about a 15% overall shrinkage in the first month. I am due to head back to NIH in the morning and I will have results of my second checkup on Thursday. I am expecting great results again. I have felt awesome, even skied on Christmas day and kept up with the kids!

I invite you all to look at my caring bridge site www.caringbridge.org/visit/melindabachini ....I tried to document this treatment as best I could this time around.

I will update with results this week....you are all always in my thoughts and prayers .....hugs, Melinda

Re: Update on NIH Trial

Melinda...don't be sorry - we are over the moon hearing from you.  So glad you have recovered and these 127 T cells are working wonders for you. 
When you are up to it, dear Melinda, you might want to place your caringbridge site in our blog thread.  This way it won't get lost in the postings.
http://www.cholangiocarcinoma.org/punbb … .php?id=31

Looking forward to your update next week. 
Hugs
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: Update on NIH Trial

Dear Melinda, you have taken a ride on the CC roller coaster and I am so glad the ride seems to have stopped. I am wishing for you to have great results this week and hoping for you to stick to skis instead of roller coasters! Best of luck on the check up.

Teddy ~In our hearts forever~ATTITUDE is EVERYTHING
Any suggestion I offer is intended as friendly advice based solely on my own experience. Please consult your doctor for professional guidance.

Re: Update on NIH Trial

Hi Melinda,

Already posted on your other one and also checked out your Caring Bridge.  Looking forward to good news after your check up.

Love & Hugs,
Darla

"One Day At A Time"

All of my comments and suggestions are just my opinions and are not a substitute for professional medical advice.   You should always seek the advice of your physician or other qualified health care providers.

Re: Update on NIH Trial

Melinda,
How exciting this is! Thank you for explaining the process. I am so impressed with your courage and willingness to be one only the pioneers of this kind of very exciting and promising treatment. I definitely will check out your caringbridge. All the best as you continue to heal! Ski on, girl!

Willow

Re: Update on NIH Trial

Wow Melinda,

Your treatment sounds very tough but also seems to be really helping keep the cancer at bay.  That is awesome!

I went back and searched the forums to get your previous updates.  I collected them into a timeline on a wikipage.  I also added this latest update.

If anyone is interested in the older updates, they are here:

http://cholangiocarcinoma.wikia.com/wiki/NCT01174121

Thank you so much for communicating your clinical trial experience!  Any information is so helpful to other patients.

I hope you continue to do so well, and please keep us up to date.

Thanks!

Jason

Re: Update on NIH Trial

I also wanted to mention that Rick added a Sticky to your postings.  Any further postings will appear in this string.

Jason and Melinda, should we add the older postings here as well?

Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

8 (edited by JScott Fri, 31 Jan 2014 20:24:16)

Re: Update on NIH Trial

Hey Marion / Melinda,

Here is the timeline I put together for the wiki (leaving out the Jan. 2014 info in this thread):


August 2012
It has been a very long time since I have posted to this site. I was diagnosed with Intrahepatic CC on 12-1-99. I had a 2/3rds liver resection only to find mets to my lungs 3 months post surgery. I have done chemo for past 2 yrs. Started with Gem/Cis combo which was very toxic to me, tried Gem alone with no success and then did Avastin until the toxicity build up again. I have numerous mets to my lungs and about 6 or so 3-6cm tumors on my liver again.

I have always kept my eyes open for clinical trials but found it very hard to get excited over more chemo. I believe that my discovering this trial at National Institue of Health was meant to be. It is called the GI-TIL trial. It is a tumor infiltrating lymphocyte immunotherapy trial. They have been using it successfully for melanoma for quite some time and have just recently opened it up for GI cancers. I am the 9th person to try it, but the first with CC. The first 8 people were unsuccessful.

I met with the research team in March and was accepted into this trial. There is certain criteria and I can't remember all of it, but you had to have been off chemo for a month and are showing signs of progression. The information is online and you can call a nurse specialist to get all the details.

My husband and I returned to Bethesda, MD about 2 weeks later and I had 4 tumors from my left lung removed. The docs then take the lymphocytes from these tumors and grow them in a lab for about 30 days. We then returned again for a 3 week hospital stay. The first week they give you 2 chemo drugs, not to treat the cancer but to suppress your immune system. The first drug was rough and the second was not as bad. The second week they infused 42.6 billion of my lymphocytes they had grown back into me!! They also give you a drug called IL2 at the same time for up to 15 doses or as many as you can handle. I only made it to 4 doses. The 3rd week was recovering my blood counts enough to go home.

I just had my 3rd monthly checkup and I have had a total of 23% overall shrinkage since this treatment. They consider 30% successful, so I am hoping to hit that mark next month! This is a one time treatment, and all I know is everyday that I don't have to do chemo is a GREAT day!
I have been leary to share with you all in case it didn't work, but then I thought it was worth sharing and let you all check into it as you seem fit.
I am almost 44 yrs old, married and have 6 children. It was worth it for me to try this treatment. The 3 weeks in the hospital was hard, but about a week or so after I got home, I started to feel better than I had in years. A chronic cough I had disappeared, my energy level increased drastically and overall just better.

We live in Montana and the good thing about this trial is that it is a Federally funded trial so they paid for all the medical costs plus my travel airfare and give you $50/day towards expenses, which doesn't cover much in that area, but was better than nothing. I also have a brother that lives 30 miles from the hospital so it all worked out well for us.

I just thought you should all know about it.....God Bless!!
Melinda Bachini

Sept 2012:
I just returned home from my 4th checkup since my initial treatment in April on the GI-TIL trial at National Institute of Health. I have officially reached the partial response rate of 30.06% and am now considered a success and the first one to be successful!!!! I seem to be averaging about a 7% shrinkage rate on my tumors each month without any treatment other than the initial treatment in April. I feel amazing and am so happy this has been working! I just wanted to update with the news! God Bless...Melinda

Dec 2012
I just returned from National Institute of Health where I am doing the TIL trial. My check up was great!! No new growth and some small shrinkage overall in my lungs and liver. The docs and scientists are excited with my results, not as much as I am though!! It has been 7 months since I have completed the treatment. I have had no further treatments or chemo of any kind and am still going in the right direction. I hope and pray that my healing continues and that the scientists can find a cure for all of us!!!! Working hard to do my part and thinking of all of you daily!!! Melinda

Feb 2013
I returned last week from NIH with stable results. No change from scans done two months ago. I am happy with stable! I am even more happy that stable came without chemo!! They say as long as there is not growth - the cells are still doing their job. I go back in March for next checkup and will keep everyone posted.

I have really enjoyed talking with so many of you over the past few months, it has been great to put voices to names. It helps to share our stories, and I want to be able to help answer any questions that I can. My prayers are with each and everyone of you...stay strong, keep the faith and God Bless you!!
Lots of Love,
Melinda

April 2013
Hi all,
I just returned from my latest checkup out at NIH. It has been one year now since I have received this TIL treatment. Scans this month still showed no growth. Stable it is......since November. While I would sure love to hear the word shrinkage again....I am still feeling that this has been successful for me. Considering that I have not had any chemo or radiation or any treatment what so ever in the last year, I feel like I have to celebrate these results!

I feel extremely blessed to have had such an amazing year with my family. While the 3 week hospital stay for treatment was not fun, I would do it again in a heartbeat to get another year like this one! I don't know what my future holds anymore than anyone else but for now I am happy with stable - I can definitely LIVE with stable!!!!!
God Bless you all!!!
Melinda

May 2013
Hi all,
I just returned from NIH this week. My scans showed minimal growth, like in 1-2 mm in only a couple of tumors in my lungs. Considering I have several tumors in both lungs and I think 4-6 in my liver...that have not grown, I am still happy with this news. We are just watching for now, I go back in the middle of August for next checkup. They have a formula for everything and won't consider it progression of disease until a certain percentage of growth. At that time I could possibly repeat the treatment, depending on the consensus of the doctors, or look for a different trial.

I am still happy with the trial results for me, I only wish that it would work for someone else as well. There is still so much of the unknown. I know for me, not having to do chemo, gave me great quality of life this past year and amazing time with my family. I still don't know what the future holds but I remain optimistic and hold on to my faith. Always thinking of you all, my fellow cc fighters....God Bless.....Melinda

Jason

Re: Update on NIH Trial

Thanks much, Jason.  This is a wonderful way of keeping threads organized.  I think we are on to something with adding Sticky's to postings.  This will allow people to update in their respective threads. 
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: Update on NIH Trial

Jason that is so awesome! Thank you so much!

Marion....does the sticky mean that I should update on this post with new results? I am headed back on the 18th for next checkup and will have the results the afternoon of the 20th.

Thanks everyone for the good wishes......all my thoughts and prayers!
Melinda

Re: Update on NIH Trial

Good luck with the checkup and results Melinda, my fingers are crossed for you  and I so hope for the best possible results for you. Please let us know how everything goes.

Hugs,

Gavin

Any advice or comments I give are based on personal experiences and knowledge and are my opinions only, they are not to be substituted for professional medical advice. Please seek professional advice from a qualified doctor or medical professional.

Re: Update on NIH Trial

Melinda....we are trying our best (with Jason's help and that of others) to organize this discussion board in a more user friendly version.  The Sticky will allow members to continue posting their treatment or other relevant information in one particular thread.  I can't wait to see your update listed right here.
A tidal wave of good wishes is heading your way.
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

13 (edited by kris00j Fri, 09 May 2014 09:58:54)

Re: Update on NIH Trial

I hope everyone got to read the article on Melinda! Wonderful!!

please use this link for the article:
http://www.nytimes.com/2014/05/09/healt … p&_r=1

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: Update on NIH Trial

Hello All,

I returned from NIH this week....8 months post treatment. I received wonderful news! I continue to have shrinkage in tumors, somewhere around a total of 42% overall since treatment. The other good news was that I had a PET scan for the first time since diagnosis of mets to lungs and it showed no evidence of metabolic activity in the tumors in my liver. I don't have to return to NIH for about 4 months, which seems like a lifetime to me! I feel so happy and so very blessed!

They told me that they were overwhelmed with calls after the articles came out, something like 400 calls in a couple of days! I also have been contacted via email, facebook, caringbridge and good old fashioned home phone....not hard to find my last name listed in the phone book....by so, so, many people! It has been an amazing journey. People just want HOPE! I even had the opportunity to meet some fellow fighters while I was back east this week.

I hate hearing when patients are not accepted into this trial. It breaks my heart, and while I know it may not work for everyone, it saddens me that people who are out of options can't give it a try. I do know that the scientists are working extremely hard to perfect this treatment and are so very hopeful for other treatments coming up.  I encourage anyone interested to still give NIH a call. I also know that it is a time saver to have the tumor sequencing already done, the scientist that works on my cells said that alone saves a month worth of work on his part, and we all know how important time is. I want to help in any way I can so please don't hesitate to contact me. I believe that we will be seeing some good results in the next couple of months and I can't wait to have more success stories!

All my thoughts, prayers and love to you all,
Melinda

Re: Update on NIH Trial

Hi Melinda,

That is fantastic news.  Thank you for letting us know how it is going.  I can't tell you how helpful it is (to me anyway) hearing stories like yours. 

If I am reading you right, when you next go back to NIH, you will have been 12 months without treatment?  Amazing.  Congrats!

One question if you have a moment:  Do you know what the NIH is looking for when they look at the genetic sequencing?  If it is something exotic, people can try and make sure it is covered when they get a sequencing done.

All the best,

Jason

Re: Update on NIH Trial

YIPPEE, Melinda! I am thrilled for you and if I could would do 100 cart wheels. Instead I will just go to the moon and back! Love, love, love the stories of hope. Keep up the good work, have fun and enjoy your summer!

Teddy ~In our hearts forever~ATTITUDE is EVERYTHING
Any suggestion I offer is intended as friendly advice based solely on my own experience. Please consult your doctor for professional guidance.

Re: Update on NIH Trial

Melinda...I too am overjoyed.  Same question as that what Jason asked:  sequencing, but to which extent?
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: Update on NIH Trial

Hi Melinda,

Brilliant news and I am over the moon for you!!! I'll try and do Lainy's cartwheels for you to celebrate!! So love hearing how things are going for you and this is great to hear! Time to enjoy your summer and yes, you give hope to so so many people out there!

Hugs,

Gavin

Any advice or comments I give are based on personal experiences and knowledge and are my opinions only, they are not to be substituted for professional medical advice. Please seek professional advice from a qualified doctor or medical professional.

Re: Update on NIH Trial

Melinda...I have e-mailed you.
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: Update on NIH Trial

Thanks for all the support.....I will do some cartwheels for sure and imagine both Lainy and Gavin next to me!!

Jason and Marion,
I don't know the specifics on the sequencing, but I am more than happy to find out! It is not required to have it done before applying for the trial, it just saves time if you already have it done.
Yes Jason, a whole year will have past without treatment! Nothing could make me happier! As soon as I get a response on the specifics, I will post them here.

I have such hope....Melinda

Re: Update on NIH Trial

Melinda, thank you so much for the update and for your offer to help others.  It's great to hear!  I have a quick question, too i you have a chance..- by tumor sequencing do you mean what firms like Foundation Medicine analyze from the cancer tumor sample to analyze genetic mutations-- or is it another kind of test?

Re: Update on NIH Trial

Melinda, wonderful news!! I am doing virtual cartwheels for you!! :-)
I discussed the trial with my onc a few weeks ago. She knows about it, and even though it isn't at Fox Chase, I don't think she would neglect to mention it to her patients if they don't get into fix chases trials.
Such an exciting, hopeful time! And you are paving the way!

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: Update on NIH Trial

All,
This is the response I received from the research scientist at NIH in regards to the tumor sequencing. It is quite an education, especially for my simple mind. I hope this helps and I appreciate his quick response and honesty at the end. This is his reply:

There are several types of sequencing, the most widely used in the clinic is “targeted sequencing”. This type of sequencing only looks at a relatively small number of genes and tests to see if these genes contain mutations. The reason why this is used in the clinic is because mutations in these specific genes can predict whether a certain drug will be effective or not, so this can be used to guide a treatment. However, this type of sequencing would likely not be very helpful to us because only a relatively small number of genes are assessed. With fewer genes assessed, we would have much fewer (or no) mutations to test. It’s already a “needle in a haystack” when we look at all the mutations, so it would be more like a “needle in a football stadium” if we only evaluated a few mutations.

Then there is whole-genome sequencing (WGS), and whole-exome sequencing (WES), both of which can evaluate the presence of mutations in most genes in the human genome. These are the types of sequencing that we can use. Both can give reliable data if the “read coverage” is high enough. What this means is that the “deeper” we sequence (the more sequence reads we get for a particular gene), then the more confident we are that it is a true mutation. For example, if we only detected one sequence containing the mutation out of 5 sequences read, this would be 20% mutation frequency, but we would be more confident that this is a true mutation if we detected, say, 20 sequences out of 100 sequences read (still 20%). This is because there are errors that can occur during DNA sequencing. The 1/5 could be an error and therefore not a real mutation, however, it’s statistically less likely that 20 errors occurred out of the 100.

The difference between whole-genome sequencing and whole-exome sequencing is that whole genome is just that, it reads every single base in your genome. However, you might remember that the importance of DNA is that it ultimately encodes for protein, which is what does all the work in our cells and tissues. It turns out that only about 1-2% of the entire genome encodes for protein. So whole-exome sequencing just sequences this 1-2% of the genome. Since mutations are only relevant to use if they affect the protein, whole-exome sequencing can be more efficient (since you don't have to sequence 98-99% of the irrelevant DNA). Both have the advantages and disadvantages (which I won’t get into here).

But to answer your question, we have used both whole-genome and whole-exome sequencing, although the vast majority of our experience is with whole-exome. It is also very important that both the tumor and a normal source of DNA from the same patient are sequenced. For example, you can sequence peripheral blood cells (from a blood draw) as a source of normal DNA. We need this as a reference to identify what is a true mutation (since, in most cases, only the tumor will have the mutation).

So in an ideal situation, a patient would come into clinic with their tumor already sequenced. This would save us about 3-4 weeks in our testing process. However, as you know, there are many factors that have to fulfilled before a patient could even be enrolled onto our protocol. There are the clinical parameters that have to be fulfilled, and it turns out when our MDs screen patients, unfortunately many are not eligible. And there are also limitations in our lab and clinical trial capacity, since we can only handle a relatively small number of patients at any one given time.

So I guess one thing I would make clear to potential patients is that even if they get sequencing done, there’s no guarantee that he/she would make it onto our trial. And even if they make it onto our trial, we are at such an early stage of research and development that we don’t know if we would even find mutation-reactive T cells to use for treatment. Although it would be unfortunate if patients got sequencing done and couldn’t get onto our trial, it potentially wouldn’t be for nothing, because the sequencing data could be used to advance science; genomics experts around the world are working together to catalogue the sequences of thousands and thousands of tumors to try to understand cancer better which hopefully will lead to better treatments in the future.



I can't tell you how much I admire this young man.....hope it helps! Melinda smile

Re: Update on NIH Trial

Melinda...thank you for the excellent explanation re: genome and whole- exome sequencing.  I am sure that many others will read this patient friendly version.
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: Update on NIH Trial

mbachini wrote:

Hello All,

I returned from NIH this week....8 months post treatment. I received wonderful news! I continue to have shrinkage in tumors, somewhere around a total of 42% overall since treatment. The other good news was that I had a PET scan for the first time since diagnosis of mets to lungs and it showed no evidence of metabolic activity in the tumors in my liver. I don't have to return to NIH for about 4 months, which seems like a lifetime to me! I feel so happy and so very blessed!

They told me that they were overwhelmed with calls after the articles came out, something like 400 calls in a couple of days! I also have been contacted via email, facebook, caringbridge and good old fashioned home phone....not hard to find my last name listed in the phone book....by so, so, many people! It has been an amazing journey. People just want HOPE! I even had the opportunity to meet some fellow fighters while I was back east this week.

I hate hearing when patients are not accepted into this trial. It breaks my heart, and while I know it may not work for everyone, it saddens me that people who are out of options can't give it a try. I do know that the scientists are working extremely hard to perfect this treatment and are so very hopeful for other treatments coming up.  I encourage anyone interested to still give NIH a call. I also know that it is a time saver to have the tumor sequencing already done, the scientist that works on my cells said that alone saves a month worth of work on his part, and we all know how important time is. I want to help in any way I can so please don't hesitate to contact me. I believe that we will be seeing some good results in the next couple of months and I can't wait to have more success stories!

All my thoughts, prayers and love to you all,
Melinda

Melinda,

This is Kim Thompson and Richard Thompson. We are SO very happy to hear about your last visit with NIH and the positive results. What a blessing you have been to so many others on this site and everywhere who are battling this. We can't begin to thank you enough for all the advice and for sharing your story so that others may be aware of their options so they don't lose hope!

Keep telling your story, you are TRULY making a difference!!!

My mother had her sequencing done and we received a call this morning that they found the specific mutation. We are awaiting a call back and will keep everyone informed.

Thoughts and prayers to everyone and be thankful for every day, it is a GIFT!

Thanks again Melinda!!!!!