TIL Immunotherapy at NCI

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Sleen
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TIL Immunotherapy at NCI

Postby Sleen » Sun Jan 11, 2015 1:05 am

I was dx in Sept/2013 Stage IIIc. FOLFOX completed Mar/2014.
Thought I had it beat after a decent CT but PET in Nov. showed some "activity".
After a lung biopsy on 12/12/2014 metastasis was confirmed :(
Now hoping for a clinical trial at NIH (NCT01174121 which is a Phase 2 that is still recruiting). Paperwork is in...they want to test the tumor for enzymes to rule out eligibility for a less-invasive trial, but I am mentally preparing for the TIL trial.

I've been told that it will be physically challenging but honestly, I think the separation from my family might be worse. A 3 to 4 week hospital stay will be required. Hubby and I have five children ranging from 19 to 5--all still at home.

If anyone here has been through this trial, I would love to hear your experience with it whether good or bad.

Celine

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Maia
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Re: TIL Immunotherapy at NCI

Postby Maia » Sun Jan 11, 2015 8:44 am

Hi Celine. I don't think anyone on this forum has direct experience with this trial but I've been following it as the promising one, regarding adaptative T-cell immunotherapy. I remember our fellow Karmel, who was a physician, considered going to try that one, but she was not able, sadly. It's the first trial of this type that shows results on solid tumours (adaptive T-Cell therapy has been more successful on blood cancers, until the moment, probably because more people with blood cancers participated in this kind of trials).

It's "Dr Rosenberg's trial"; the former name of the trial was "A Phase II Study Using Short-Term Cultured, CD8+-Enriched Autologous Tumor-infiltrating Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Digestive Tract Cancers" (you see that I mention it like that, in an old post copied below); now it's "Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer", so you may find information under both denominations (the number is always the same, NCT01174121 https://www.clinicaltrials.gov/ct2/show/NCT01174121 )
Anyway, I did some posting about it in the past (1, 2 ), so I thought about putting together the information here, for you to read easily:


**************************

New York Times, May 8 2014
Patient’s Cells Deployed to Attack Aggressive Cancer

Doctors have taken an important step toward a long-sought goal: harnessing a person’s own immune system to fight cancer.

An article published Thursday in the journal Science describes the treatment of a 43-year-old woman with an advanced and deadly type of cancer that had spread from her bile duct to her liver and lungs, despite chemotherapy.

Researchers at the National Cancer Institute sequenced the genome of her cancer and identified cells from her immune system that attacked a specific mutation in the malignant cells. Then they grew those immune cells in the laboratory and infused billions of them back into her bloodstream.

The tumors began “melting away,” said Dr. Steven A. Rosenberg, the senior author of the article and chief of the surgery branch at the cancer institute.

The woman is not cured: Her tumors are shrinking, but not gone. And an experiment on one patient cannot determine whether a new treatment works. But the report is noteworthy because it describes an approach that may also be applied to common tumors (...=

More: http://www.nytimes.com/2014/05/09/healt ... &smv2&_r=1



They mention Dr Carl June there, and also Michel Sadelain (MSK). There is a good 2012 article to read at Nature, from the three of them (full, here).

Fortifying the immune system to fight off cancer

Thomas James and Andrea Roane, WUSA 12:14 p.m. EDT May 22, 2014

Now Dr. Rosenberg and his team of NIH scientists have developed a new immunotherapy method that's showing promise in attacking a wide range of cancers.

Bethesda, Md.
(WUSA9) -- Cancer kills over 20 thousand people a day worldwide, according to the American Cancer Society. For years, researchers have looked for different ways to stop this foreign invader.

Steven A. Rosenberg
, MD, PhD of the National Cancer Institute says now if you develop cancer, you have a 50 percent chance overall of being cured. He says, "We have 3 effective ways to treat cancer now, surgery, radiation, and chemotherapy."

"The problem is half of the people that develop cancer are not cured by those modalities and we're in desperate need of new approaches to treatment," adds Dr Rosenberg.

A leading researcher and cancer surgeon, Dr. Rosenberg developed the first effective immunotherapies and gene therapies for patients with advanced cancer. Immunotherapy uses the body's own defense system to target and kill cancer cells. But it's reach was limited to cancers that are highly mutated, like melanoma.

Now he and his team of NIH scientists have developed a new immunotherapy method that's showing promise in attacking a wide range of cancers.

Dr. Rosenberg says, "In this new treatment, what we do is identify all the mutations that are present in a cancer. And develop methods to find out which individual mutations are recognized by the body's immune system, not all of them are.

With this new information, scientists can actually grow immune cells that can see the changes and destroy the cancer. This approach was applied for the first time in 46 year old Melinda Bachini. A Montana woman who had tumors that spread throughout her body.

Bachini tells Aja Goare of KTVQ-TV, "They found a specific T-cell that reacts to that specific mutation in my cancer and grew specifically that one for a month, they put billions of them back in me."

Dr. Rosenberg says, "Her tumors started in the liver and in fact those tend to be very difficult cancers to treat because they start in the epithelial linings of different organs."

In fact, over 80 percent of the deadliest cancers start in the epithelial tissues, including lung, prostate, pancreatic, and colon cancer.

So far, the patient is responding well to this emerging therapy. Her tumors are melting away. Dr. Rosenberg says they are working around the clock to improve on this treatment for more patients.

Bachini says, "The made a blueprint with me so that's where they've started, so I'm the first but I hope i'm the first of many."

This therapy is in very early stages so it is no where near ready for prime-time. But Dr. Rosenberg says the research provides a blueprint to attack specific mutations that are unique to a patient's individual cancer.

The National Cancer Institute is a component of the National Institutes of Health.
Image

Video at http://www.wusa9.com/story/news/health/ ... t/9436859/


And an interview to that patient from Dr Rosenberg's trial (A Phase II Study Using Short-Term Cultured, CD8+-Enriched Autologous Tumor-infiltrating Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Digestive Tract Cancers):

May 18, 2014 8:27 PM by Aja Goare - Q2 News
Billings woman experiences success as first patient in trial cancer treatment

BILLINGS - The cure for cancer is something doctors and scientists have searched for, for years.

Though there's no proven cure, a new trial treatment is giving hope to one woman, right here in Billings.

"Four and a half years ago I was diagnosed with cholangiocarcinoma, which is the cancer of the bile ducts," said Melinda Bachini. "It's very rare and there is no proven treatment for it right now. So I knew at the time we'd have to find something experimental and new if we wanted to beat it."

So she began her search online.

"I stumbled across it on the computer, I can't even tell you how. I clicked on it and it was like boom - it was there," she said. "And just reading it, I was convinced from that moment that this is what I want to do."

It was a last click effort to end the battle that she just couldn't stand to fight any more.

"At the beginning of 2012, I was just about ready to be done with chemo and have better quality of life than quantity, and I came across the clinical trial at the institute of health in Bethesda, MD."

It was a trial with no previous patients and no proof of success - a true experiment.


"I'm listed as patient 3737, but I've never felt like a number."

Number 3737 in a journal of science, but a living, breathing mother of six in real life, who can do a much better job at explaining the treatment than 10 syllable words on in a journal.

"To me this is the simple way of saying it," she began. "They found a specific T-cell that reacts to that specific mutation in my cancer and grew specifically that one for a month, they put billions of them back in me."

Billions of her own T-cells are diminishing the tumors day by day. The battle's not over, but the building blocks for survival both for Melinda and others with cancer are there.

"They made a blue print with me so that's where they've started, so I'm the first but I hope I'm the first of many."

Now, because there's no way of knowing if this form of immunotherapy treatment will work the same for every patient and all cancers.

The trials are still in the early stages, but for Melinda the tumors are shrinking.
Image

Video at http://www.ktvq.com/news/billings-woman ... treatment/


-----------------
Rosenberg et al. article, Cancer Immunotherapy Based on Mutation-Specific CD4+ T Cells in a Patient with Epithelial Cancer, full, here. Supplementary Materials

-------

Celine, I wish you the best!

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DK37
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Re: TIL Immunotherapy at NCI

Postby DK37 » Sun Jan 11, 2015 9:01 am

I was in the middle of writing a similar synopsis when you beat me to it Maia - you rock!

A trial I have been following very closely for the reasons Maia posted & on my short list of trials for myself.

Good luck Celine! And please if possible keep the board informed. Trials like this are the future of medicine...

-DK
6/4/2012 Dx Stage 3C CRC @ 40 yo. MSS, KRAS-WT, BRAF-WT, p53-mut
7/12 FOLFOX/FOLFIRI
2/13 NED!
8/13 Enlarged lymphs - Stable
10/14 Stage IV. Lung & Lymph mets. 5-FU+bev
3/15 Cetuximab
11/15 FOLFIRI + bev
11/16 Signs of FOLFIRI resistance (Lymph mets)
1/17 Palliative radiation for resistant mets
2/17 FOLFIRI + bev + Maraviroc (off-label)
3/17 FOLFIRI + Erbitux + Maraviroc (off-label)
MSS-CRC Clinical Trial Finder: http://trialfinder.fightcrc.org/
2016 Colondar 2.0 Model
DK37 Science Posts List

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Maia
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Re: TIL Immunotherapy at NCI

Postby Maia » Sun Jan 11, 2015 9:18 am

That was just copy & paste skill, DK! :wink:

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Sleen
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Re: TIL Immunotherapy at NCI

Postby Sleen » Sun Jan 11, 2015 3:56 pm

Thanks for consolidating all of that. I've got big hopes for success with this one.
Will keep the board posted as treatment progresses.
my blog: Cancer Riot

NED since April 2016!
April 2016: lower left lung lobectomy. NED
8 mo. f/u: 1 of 7 tumors progressed.
6 mo. f/u PR confirmed (Jan 2016)
Jul 2015: NIH TIL trial NCT01174121 NCI/NIH Surgery Branch FAQ
Dec 2015 stage IV w/bilateral lung mets
FOLFOX + Radiation (bladder)
KRAS G12D :: MSS
dx Sep 2013 @47yo: IIIc T4b N2b MX [bladder invasion, 17/21 lymph nodes]

Married 26 yrs. kids: 21, 18, 15, 10, 8
SE Michigan home schooler, mechanical engineer, and programmer.

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lilacbreastedroller
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Re: TIL Immunotherapy at NCI

Postby lilacbreastedroller » Tue Jan 13, 2015 4:51 pm

I just got into this trial. Celine if you're in, pm me.

I did the paperwork, went to nci for the physical and interview, and have been accepted as a white mouse :-), so I'm just at the beginning stages. Next step is to have tumor extraction so that they can harvest the TILs. It's not a complete green light because at certain checkpoints, I can be bounced from the trial, ie if my cells don't grow, for instance.

If no one minds, I will post my progress on this thread? Would make information easier to find IMO.

Karin
dx 6/1/12@45yo
RT, 4 liv, 5 lung
7/12 FOLFOX
2/13 Xeloda 4k mg/d
7/13 DC VAX,1k mg/d metro Xel
11/13 Erbi, Irino
6/14 clinical trial lirilumab, nivolumab
9/14 Stivarga
1/15 clinical trial immunotherapy (young TILs)
RT, mets to liv, lung, adrenal, lns

Cb75
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Re: TIL Immunotherapy at NCI

Postby Cb75 » Tue Jan 13, 2015 5:52 pm

Very interesting. Please keep us posted on this thread, if possible.

cb
39y female Stage IV
diagnosed April 2012
sigmoid resect May 2012
liver resect Aug 2012
Folfox Oct 2012
lungs Sep 2013
R and L laser lung resection Nov 2013/Feb 2014
FOLFIRI and Avastin Apr 2014 ongoing...

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DK37
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Re: TIL Immunotherapy at NCI

Postby DK37 » Tue Jan 13, 2015 6:08 pm

Yes please keep is posted with as much info as you are comfortable sharing!

Thank you & good luck!!!

-DK
6/4/2012 Dx Stage 3C CRC @ 40 yo. MSS, KRAS-WT, BRAF-WT, p53-mut
7/12 FOLFOX/FOLFIRI
2/13 NED!
8/13 Enlarged lymphs - Stable
10/14 Stage IV. Lung & Lymph mets. 5-FU+bev
3/15 Cetuximab
11/15 FOLFIRI + bev
11/16 Signs of FOLFIRI resistance (Lymph mets)
1/17 Palliative radiation for resistant mets
2/17 FOLFIRI + bev + Maraviroc (off-label)
3/17 FOLFIRI + Erbitux + Maraviroc (off-label)
MSS-CRC Clinical Trial Finder: http://trialfinder.fightcrc.org/
2016 Colondar 2.0 Model
DK37 Science Posts List

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Maia
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Re: TIL Immunotherapy at NCI

Postby Maia » Tue Jan 13, 2015 6:09 pm

OMG, Karin! I'm so happy for you!!
So, did they admit you, even after you already had a previous immunotherapy (the nivo-iri trial)? Skypuppy... hear that!!! :)
Thank you for such good news.
Please, keep us updated, yes. :D
Everything crossed for you!

Edited to add: would love if you can explain us how do you got in a metronomic chemo regimen (as it shows in your signature). There is a thread devoted to metronomic chemo here: viewtopic.php?f=1&t=49549

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bitchslapped
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Re: TIL Immunotherapy at NCI

Postby bitchslapped » Tue Jan 13, 2015 8:02 pm

So we may have two members on the same trial? WOW. I think it is invaluable when people report back on their experiences through clinical trials. It may seem like a lot to ask sometimes, but this kind of information is not available through any reporting resources currently & can help so many through real time experience.

So I just will say "Thank You" for your courage & generosity in sharing your journey w/us.

Best Wishes

Bitchslapped
DSS,35YO,unresect mCRC DX 7/'14,lvr,LN,peri,rib
FOLFOX+Avstn 4 Rnds d/c 10/'14
Stent 9/'14
FOLFIRI+Avstn 10/'14
Gone From My Sight 2/20/15
Me:garden variety polyps + precancerous polyp
Carergver x2 DH,DM dbl occupancy,'03-'10
DH dx 47YO mCRC,'04-'07 fried x HAI
DM dx CC 85YO,CC,CHF,stroke,dementia,aphasia

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Sleen
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Re: TIL Immunotherapy at NCI

Postby Sleen » Tue Jan 13, 2015 8:22 pm

Congrats, Karin!
NCI wanted to test the original tumor for possible eligibility in 3 (4?) other trials before having me come out for the in-person screening and surgery. Only problem with that is that the University of Michigan is apparently holding my tumor hostage.

so annoying!

Celine
my blog: Cancer Riot

NED since April 2016!
April 2016: lower left lung lobectomy. NED
8 mo. f/u: 1 of 7 tumors progressed.
6 mo. f/u PR confirmed (Jan 2016)
Jul 2015: NIH TIL trial NCT01174121 NCI/NIH Surgery Branch FAQ
Dec 2015 stage IV w/bilateral lung mets
FOLFOX + Radiation (bladder)
KRAS G12D :: MSS
dx Sep 2013 @47yo: IIIc T4b N2b MX [bladder invasion, 17/21 lymph nodes]

Married 26 yrs. kids: 21, 18, 15, 10, 8
SE Michigan home schooler, mechanical engineer, and programmer.

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lilacbreastedroller
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Re: TIL Immunotherapy at NCI

Postby lilacbreastedroller » Wed Jan 14, 2015 7:50 am

Arrgh re: hostage taking. How frustrating

Maia - thanks!!! Re: metronomic. The onc at the time believed in metronomic doses and that's just what he prescribed. It was easy. Also re: exclusions. This trial,didn't exclude prior treatments. I checked other immunotherapy trials and some has very specific wording that excludes certain prior,treatments. So if the trial exclusions listed don't say no, assume a yes. :?
dx 6/1/12@45yo
RT, 4 liv, 5 lung
7/12 FOLFOX
2/13 Xeloda 4k mg/d
7/13 DC VAX,1k mg/d metro Xel
11/13 Erbi, Irino
6/14 clinical trial lirilumab, nivolumab
9/14 Stivarga
1/15 clinical trial immunotherapy (young TILs)
RT, mets to liv, lung, adrenal, lns

Julie YW
Posts: 170
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Facebook Username: Julie.yip-williams

Re: TIL Immunotherapy at NCI

Postby Julie YW » Wed Jan 14, 2015 9:21 am

Good luck Karin and Celine. My onc thinks this type of immunotherapy is the most promising for crc (but of course he's just guessing). All trials take a lot of guts but this one especially so. Thank you.
DX July 2013, 37yo
12 of 68 LN
Stage IV w/ drop peri met
Folfox 8/12/13
Clean scans 1/24/14
Rising CEA 2/13/14
HIPEC 3/13/14
Folfiri 4/21/14
Recurrence in lungs 12/19/14
Xeloda & Avastin
Follow my blog: http://julieyipwilliams.wordpress.com/about/

lpas
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Re: TIL Immunotherapy at NCI

Postby lpas » Wed Jan 14, 2015 9:37 am

I'm far from an expert on immunotherapy trials but this one has me feeling really hopeful. Congrats to both of you on getting in! I hope you'll keep us posted.
11/14 Dx sigmoid CC @ 45yo
12/14 Colectomy + hysterectomy
Stage IIIB, T3N1bM0, 2/20 nodes, MSS, G2, KRAS(A146T), TP53, SMAD4, ERBB2, CEA 1.0
2/15-7/15 XELOX, Celebrex & many supplements
3/16 Ovarian mass removed. Benign fibroid
9/16 clean colonoscopy
3/17 clean CT
Ongoing Celebrex, cimetidine & other carefully-targeted supplements
Post-chemo CEA 3.0, 2.5, 2.3, 2.0, 1.6, 1.3, 1.8, 2.1, 1.8, 2.0, 1.8, 1.9, 1.7, 1.5, 1.6, 1.5, 1.4, 1.4, 1.3, 1.3, 1.6, 1.6, 1.3
Mom to a 3 & 6yo

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Sleen
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Re: TIL Immunotherapy at NCI

Postby Sleen » Fri Jan 16, 2015 3:46 pm

Just got off the phone with NIH.
The tumor they were planning to remove for the TIL study is the same one a previous surgeon already removed to prove metastasis. The NIH doc thinks the other tumors in my lungs are either too small, or not in a good location.

I'm currently not on any meds, because my oncologist wanted to wait for news on this trial. Now I suppose I'll remain off any meds until another ct can be ordered and sent to NIH to have them revisit whether any of the tumors are now big enough. The one they wanted to resect measured 1.4cm in Nov. That same scan shows a nodule in the opposite lung as 1.2 cm...pretty sure that one will be "big enough" by the time I can get another scan.

In other news. Since the university hospital has been so slow getting my slides to NIH for the ESO trial(s), we requested that the local hospital cut new slides. Those will be at NIH by next Tuesday. There is some hope that NIH will find the particular antigen(s) they're looking for, and combined with my "HLA-typing", I may be eligible for those trials. I've been found to be AO2, which means "good", but there are further classifications that have to be evaluated too (Class 1 / Class 2 typing). Not sure what any of that means. All bets are off if they don't find the antigens on the slides though.

My plan is to forego chemo until another scan is done and re-evaluation made for the TIL study.
UNLESS my tumor qualifies me for one of the ESO trials. Should know within a few weeks on that score.

The university doc that I saw on 12/31 said he thought I was OK to be off any meds for "about six months".

I'm frustrated, but still hopeful for a trial.
my blog: Cancer Riot

NED since April 2016!
April 2016: lower left lung lobectomy. NED
8 mo. f/u: 1 of 7 tumors progressed.
6 mo. f/u PR confirmed (Jan 2016)
Jul 2015: NIH TIL trial NCT01174121 NCI/NIH Surgery Branch FAQ
Dec 2015 stage IV w/bilateral lung mets
FOLFOX + Radiation (bladder)
KRAS G12D :: MSS
dx Sep 2013 @47yo: IIIc T4b N2b MX [bladder invasion, 17/21 lymph nodes]

Married 26 yrs. kids: 21, 18, 15, 10, 8
SE Michigan home schooler, mechanical engineer, and programmer.


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