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NCT01174121

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Summary and ResearchEdit

A Phase II Study Using Short-Term Cultured, CD8+-Enriched Autologous Tumor-infiltrating Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Digestive Tract Cancers

Details regarding the trial available here.

Participant Experiences and SuggestionsEdit

Member mbachini from CCF Forums:

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
January 2014
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 ....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


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