Re: Update on NIH Trial

YIPPEE, Melinda, YIPPEE! Great news. You are a vision of HOPE and MIRACLES!

THANK YOU FOR LOVING ME! 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,

What absolutely brilliant brilliant news for you and Lori as well! Majorly chuffed for you both! Thank you so much for sharing this with us all! As far as taking this news and running with it, you go for it and run, run, run!!!

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

Dr. Rosenberg was awarded for his many years of public service within the NIH:
http://www.washingtonpost.com/lifestyle … story.html

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

MARION...thanks for posting that write up on Dr. Rosenberg.  It's really good to put a face to a name.   And MELINDA...great news about you and Lori.....wonderful to hear that others seem to be having good....no GREAT results from the immune therapy.  If you hear anything about any of the others in the program, we'd love to hear more good news if they'll allow you to share.

Julie T.

"Just for today, I can get through anything."  I'm a cancer survivor, not a doctor.  The opinions I state are my own, based on my personal experiences.    As always, talk to your doctor about your concerns and treatment.

Re: Update on NIH Trial

Thanks for that Marion!

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

So happy to see Dr. Rosenberg recognized for his amazing work. He is by far the most humble person I have ever met.

Thanks Julie.....I would like nothing more than to be posting more great results!! Soon, I hope.

Melinda

Re: Update on NIH Trial

Melinda, it is so terrific to read all of the details about the continued success of your treatment with Dr. Rosenberg and the NIH team.  About a month ago, a few weeks before I found this terrific website, I came across the May 8, 2014 NBC News article that was published about the success you have had with the Immunotherapy treatment while I was researching options for my mother, who I recently posted about in the Introductions and General Discussion topics of this forum.  After a resection of about 60% of her liver and 6 months of adjuvant chemotherapy, we thought she was cancer free.  Her scan at the end of the adjuvant therapy came back clear of cancer and her blood results were all coming back clean.  They then scanned her again six months later and found the cancer had returned very aggressively. Not only additional tumors in her liver but metastasis to her lungs and even possibly on her spine. 

When I saw the NBC News article, I was so pleased to learn about your terrific improvement and success with the trial.

I immediately got in touch with Dr. Rosenberg's team and was working with Ellen to secure a spot in the trial for my mom.  Everything was looking good for her to participate and they even sent a blood kit in the mail but once they saw her most recent scan, they said she would not be eligible, apparently due to the significant spread of the cancer.  We were surprised and disappointed and we did not know of any better option than to take the recommendation of the oncologists at Morristown Memorial and the GI team at Memorial Sloan Kettering and get her started on FOLFOX.  I followed up with the NIH team and asked if she might become eligible if the FOLFOX is successful in shrinking her tumor and got a curious response that basically boiled down to "unlikely, but anything is possible, although we are actually not having much luck with the trial other than for some melanoma patients."  I was surprised to hear that they were not considering the trial to be successful considering how terrific your treatment has been, but perhaps I misunderstood her response.

Mom is now two treatments in and it is wreaking some havoc on her body but we are holding out hope that it will be effective and, at the same time, trying to determine if there are any trials that might offer hope so we are ready to move in a different direction as quickly as possible if needed. 

We are also waiting on molecular testing being conducted by MSK and holding out hope that the results present the chance for her to receive targeted treatment similar to the NIH immunotherapy treatment.

Please keep us updated on all of your successes.  These positive results provide hope for all of us!

Thanks so much for all you are doing to share your story and assist others going through the same thing!

Best,
Steven

Re: Update on NIH Trial

Dear Steven,

I am so sorry to hear about your mother, and will keep her in my prayers. I hope that the FOLFOX will do some damage to those tumors, without causing her too much havoc.

Unfortunately, at this time it is true that the trial I am in has not had any responders as successful as the response I have had. They learn from all, and continue to perfect and work around the clock to find more ways to utilize the immunotherapy response. I will let everyone know of any further information that I get from other patients as well as my trial team. .....though I still believe that the number of patients is not really that high and with more patients they will eventually find more responders. I will try and get more factual data and post when I do. In the meantime we keep looking and fighting for what ever new treatments we can. Research is so important for this disease and progress is being made....just never fast enough.

All my best to you and your mother,
Melinda

Re: Update on NIH Trial

Melinda, thank you again for taking the time to speak with me today!  Your kindness and generosity absolutely amaze me.  I feel truly honored to have had the chance to speak with you and am immensely grateful for your time and consideration.

Sincerely,
Steven

Re: Update on NIH Trial

It has been TWO YEARS since my last treatment!

I just returned from NIH, where my scans still show no change. I am beyond thrilled with this news! Even though it never gets easy no matter how many times I go for scans, waiting for the results, always wondering what is going on in my body......you all know what I mean. Next checkup in 3-4 months and they will do a PET scan to see if there is any metabolic activity going on in what is left.

Some details about the trial. There have been a total of 10 patients treated in the past two years, counting me, with the mutation reactive t-cell treatment. Unfortunately, not a lot of success yet. One other patient with a response. I learned that for some reason my t-cells seem to stay alive in my blood, longer then others and they are trying to understand why.  They are working on figuring out how to fix that, and a new trial protocol has just been written, but trial won't be open for about another 3 months that involves putting the mutation reactive receptor on healthy t-cells in the lab. (remember this is my lame description, but hopefully you get the gist of it.)

Lori, the other cholangio patient I posted about last time, unfortunately at her second checkup had quite a bit of growth, after having almost 50% shrinkage the first month. The exciting thing is she was just retreated with her mutation reactive t-cells with the addition of the pd-1 receptor added to them. Her tumor expressed the pdl-1 or whatever is expressed for the pd-1 so there is still hope. She is the first and only patient to have this done so far.  Her results will be November 5th, so please keep her in your prayers. Wouldn't it be great to have something else in our arsenal!!

Charmin the other cc patient hoping to do my treatment, didn't have any cells that grew. She entered into another trial https://clinicaltrials.gov/ct2/show/NCT01853618 so hopefully she will have good news as well!

As always, you are all in my daily prayers. I am so thankful for this board and all the support I have received over the past almost 6 years. There is hope in the future of this dreadful cancer. So many, working so hard to make a difference. Thank You!!

Lots of love,
Melinda

Re: Update on NIH Trial

Fantastic news Melinda! I'm so happy for you and thank you so much for blazing the trail for the rest of us and those to come.

Re: Update on NIH Trial

The best thing about trail blazers is the news that the trail is paved with gold! Great going Melinda and wishing for the best news to keep coming. You are a true "Pioneer".

THANK YOU FOR LOVING ME! 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

Superb news Melinda, love it!!!

Huge celebratory hug for you!

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

Wow Melinda......that's just the best news for you and for us to read.  Thank you for doing what you're doing for yourself, but also for all the others of us out here.

Julie

"Just for today, I can get through anything."  I'm a cancer survivor, not a doctor.  The opinions I state are my own, based on my personal experiences.    As always, talk to your doctor about your concerns and treatment.

Re: Update on NIH Trial

Wanted to share some more on the research of my clinical trial. A paper was again published in Science journal yesterday, but here is a write up about it from National Cancer Institute.
http://1.usa.gov/1Sc2xRw

Re: Update on NIH Trial

The NCI team is already moving ahead with plans for an early phase clinical trial that follows on these findings, Dr. Rosenberg said. 
http://www.cancer.gov/news-events/cance … sf42099966

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 CC Family,

I just returned from NIH, where I had a PET scan, CT scans and MRI, along with blood work. It has been 27 months since my treatment. I have had NO other treatments in that time frame. My tumors have shrunk incredibly in that time.

While I was hoping that this month's scans would show more shrinkage or proof of just scar tissue remaining, that was not the case. My results by criteria of the trial were STABLE, which is GREAT! Unfortunately, the PET scan showed increased uptake in a handful of tumors in my lungs, except one, which showed no uptake at all! By eye they also felt that a few lung tumors were a bit plumper in my lungs. These results leave us wondering if this monster could be on the rise again. I will return in 3 months and depending on scans then, we will form a plan of action. It is also important for me to note that the spots on my liver had no uptake of glucose as well on the PET, which is also GREAT.

So all in all, these are great results. I can't deny that my heart sank a bit at first but I know that what has been accomplished in 27 months is amazing , wonderful and miraculous!!!

They have added to the treatment the drug pembrolizumab. They feel that this could increase the response to the mutation reactive t-cells. So if worse comes to worse, I will most likely do the treatment again with this addition, but for now it is a wait and see.

I still hold so much hope for the future treatments coming our way. Hang in there, good things happening.

All my best,
Melinda

Re: Update on NIH Trial

Melinda,

Thanks so much for the update. Your long-lasting response to the treatment 27 months ago is still amazing.

If you've got a compatible mutation, why you wouldn't start the pembrolizumab/Keytruda immediately? 

-Matt

Re: Update on NIH Trial

Matt,

Technically by RECIST criteria measurement, criteria of the trial, I have not yet shown progression of disease.  In fact, with the way the measurements are....there was no change.

My husband asked that question to one of the team members, why not just start the pembrolizumab right now,  and he said he thought that would be a good idea, but I don't think it was brought up again with the rest of the team. I will definitely shoot off an email in the morning to find out why.

Melinda

Re: Update on NIH Trial

Let me know if you do start it - I'd love to know someone else taking it and would be happy to answer questions or compare notes. wink

Re: Update on NIH Trial

Melinda-  wishing you the best-  you are our shining star.  Even if it wasn't for CC, anyone who can raise such a large and wonderful family, deserves an award. With clinicals, it is frustrating to see that most make you progress on treatments which on average can only extend life 3 months and also wear the  body down.  I hope they allow you to get on new treatment ASAP.

Matt-  hope you're doing well.

Take care,
Catherine

Re: Update on NIH Trial

Hi Melinda,
We just finished watching your presentation at the 2016 CCF meeting and want to thank you for your strength in sharing your story with the cholangio community. It is so powerful to see another person’s story, to understand how similar our experiences are. You are truly an inspiration to us. We wanted to write you to share our story and to seek your insight and advice, particularly on the NIH trial. I am a 43 year old who was diagnosed with stage 4 intrahepatic cholangiocarcinoma in June 2015. In addition to a large tumor (~10 cm) in the liver, a number of smaller satellite hepatic tumors were identified as well. The local lymph nodes were swollen and about 10 pulmonary tumors (~1 cm) were also identified, indicating metastatic disease. Shortly after my diagnosis, my wife heard your story, which has served since to provide us with inspiration and hope. We have a 3 year old daughter and a 4 month old son, who also provide us with inspiration. We have two beloved dogs who are part of the family and have provided us with great support as well!

A quick rundown of my treatments to date: We are located in Maryland and have been working with Johns Hopkins. Starting in July, I have had two chemoembolization (TACE) procedures targeting the large tumor in the liver. I have also been on Gemcitabine/Cisplatin for about six months to attack the metastatic disease. (I appreciated your description of the Gem/Cys treatment and steroidal side effects.)

We were very interested in enrolling in the T-cell immunotherapy NCI clinical trial at NIH that has been so successful for you. Last July, after a CT scan showing progression (new and growing tumors in my lungs), we worked with NIH to determine my eligibility in their trial. We sent blood samples, biopsy material, etc. The necessary markers were identified that would have made me eligible. However, and here we can report some good news, the TACE procedure at Hopkins has actually turned out to be quite successful in killing cancerous cells in my liver, to the extent that there was no “kill site” identified, i.e. no good location to harvest pure tumor cells. NCI essentially told me that I would need to grow some new pure tumor material for them to have enough material to work with. The cm-sized tumors in my lungs were too small to extract, as laproscopic techniques would require tumors at least 2 cm in diameter.

Finally, we traveled to MD Anderson to meet Milland Javle, who said he knows you well, to find out what other emerging treatments might be available to us. He mentioned targeted chemotherapy and immunotherapies as being possibilities.

Currently, the size of the lesions are stable to slightly decreasing. The decrease seems to be mostly in the liver tumor and may be due to the TACE procedures, which killed many of the cancer cells, leading to slow shrinkage over time. We have reached the end of the standard-of-care Gem/Cis treatment (about 6 months of treatment). While additional gem/cis chemo treatment treatment is not required at this point, we have decided to continue this treatment for the foreseeable future. I have mixed feelings, because I am too fatigued to work and am becoming despondent being stuck at home in a useless state. 

We are trying to learn as much as possible about the treatment options available so that when we reach a state of progressive disease, we can make an informed decision.  You mentioned in your CCF meeting talk that something like 12 (?) patients have been treated in the NCI trial, with 3 having partial responses. Could you clarify the number of patients with solid tumors that have been treated in the trial, the number of cholangio patients, and the number of patients who have responded? Of course, it is difficult for the public to get information about what is happening in ongoing clinical trials. BTW, the Washington Post just published an article yesterday about an Adoptive Cell Transfer study in Europe: https://www.washingtonpost.com/news/spe … e%2Fstory.

I also am curious whether extreme fatigue was ever an issue for you. I have found such fatigue to be the primary obstacle for me in getting back to work and living as I would like to live.

Thank you once again for what you are doing for the community,
Chris and Laura

Re: Update on NIH Trial

Chris and Laura,

The 12 people that have been treated are not all cholangiocarcinoma patients, there is a mix of solid cancers being treated. What I know for sure is that one of the three is a colon cancer patient, she just received her official partial response  a few weeks ago and we stay in touch by email quite frequently. She is doing great. I believe, but am not certain that one was an esophageal cancer patient and am not sure they officially hit the partial response. There is Lori Whiting, who is happy for me to share her story, she is a fellow cholangio patient. She has done the treatment twice, being the first to add the immunotherapy drug, pembrolizumab to her second treatment. She has had a mixed response. Just this past month her liver and lung tumors continue to shrink, but they found 4 mets to her brain. They are using radiation to the brain and feel quite confident they can get them with that and are continuing to treat her on the trial with the pembrolizumab.

With the addition of the pembrolizumab, I am hoping to see more responses. They are also working on using the receptors from the t-cells and putting them on young, healthy cells in the lab and then treating with those. ......(more complicated than that, but I am not capable of description!) My point is there are continuing to improve the immunotherapy treatment all the time!

Dr. Javle is highly regarded  when it comes to dealing with cholangiocarcinoma and I know several of his patients. You would definitely be in good hands there.

It seems to me you are doing everything you can to have a plan B, that is what is important, always striving for the next best treatment and hanging in there until we find a CURE!

I very much felt fatigued during and after chemo. I really didn't beat the fatigue until after I was treated at NIH. Then I was able to start walking and exercising again which helped.

I would also love for you guys to introduce yourselves in the introduction section so others can see this post and welcome you to the discussion board. I am so glad you are here, you will find much support from everyone on this board.  I am happy that the TACE is doing good.....progress is good no matter what!! Take care and I am sending hugs and prayers your way!

Melinda

Re: Update on NIH Trial

Dear All,

I had my checkup at NIH this past Tuesday. I am very happy to report that there is absolutely NO change from January. The reactive t-cells are still present in my circulation and keeping the cancer in check. I will return in another 3 months or so and have a PET again to compare to the one I had in January. I can't tell you how grateful, happy and relieved I am, after January's check up I have been a bit nervous!

So to date it has been 30 months since last treatment. I am not cancer free, but can live a great quality of life. I am very happy with these results and hope for others to have them as well. I know that a colon cancer patient has made her official partial response in this treatment. I believe there is a cc patient who has been stable for 4 months now......more hope.

I was able to meet Chris and Laura in person at NIH this week and enjoyed getting to know them in person. Chris posted his story in this thread a few posts up.

All my best,
Melinda

Re: Update on NIH Trial

Hi Melinda,

Thanks for the update and brilliant news!!! Thanks loads for sharing that with us all! Yep for sure, you and your treatment and progress gives so many people tons and tons of hope!

Big celebratory hug for you!

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.