Immunotherapy trial for those NED

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Maia
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Joined: Fri Aug 24, 2012 8:00 am

Immunotherapy trial for those NED

Postby Maia » Thu Nov 17, 2016 8:29 pm

Posting this ****for those NED*** after surgery or any other treatment. Immunotherapy to prevent recurrence.

A very new trial, posted some days ago and already recruting.
A Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of six treatment arms. Subjects will be assessed according to standard of care. hTERT means "Human Telomerase Reverse Transcriptase". A vaccine.

hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse (TRT-001)
https://clinicaltrials.gov/ct2/show/NCT02960594

A development by Inovio. http://www.inovio.com/products/cancer-vaccines/htert/

Michigan, Pennsylvania, North Carolina, Minnesota.
(Before you ask: yes, I see they mention breast, lung and pancreatic and then they list many more cancers, colorectal included. I don't know what that could mean. Someone should phone and check and let all us know what's going on)

Lee
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Joined: Sun Apr 16, 2006 4:09 pm

Re: Immunotherapy trial for those NED

Postby Lee » Sun Nov 20, 2016 5:07 pm

Bumping this back to the top. Look promising for new members.

Thanks Maia,

Lee
rectal cancer - April 2004
46 yrs old at diagnoses
stage III C - 6/13 lymph positive
radiation - 6 weeks
surgery - August 2004/hernia repair 2014
permanent colostomy
chemo - FOLFOX
NED - 16 years and counting!

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Maia
Posts: 2443
Joined: Fri Aug 24, 2012 8:00 am

Re: Immunotherapy trial for those NED

Postby Maia » Sun Nov 20, 2016 7:02 pm

You're welcome, Lee! So nice to see you : )

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Maia
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Joined: Fri Aug 24, 2012 8:00 am

Re: Immunotherapy trial for those NED

Postby Maia » Wed Jan 18, 2017 8:56 am

Bumping for Maellous.

plastikos
Posts: 351
Joined: Wed Jan 14, 2015 6:09 am

Re: Immunotherapy trial for those NED

Postby plastikos » Wed Jan 18, 2017 9:51 am

Wow. Why wasnt this around when I was NED? Still great news. Hope the trial results in protocols that can be applied in actual clinical practice.
St. IV Colon CA @ 37, male, Kras wild, MSI-high (2014)
11/2014 Right Hemicolectomy + Liver Resection
12/2014 - 6/2015 FOLFOX + Cetuximab
10/2015 - Recurrence liver
Liver resection 10/2015
FOLFIRI 11/2015 - 5/2016
Recurrence liver, nodes 11/2016
Pembrolizumab started 12/2016 -> pseudoprogression(?) -> biliary obstruction -> biliary stenting
Chemo 4x: most mets inactive and smaller on PET-CT
March 2017 - Back on Pembrolizumab again
Sept 2017 - SIRT - > NED
2019 NED

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ktwmn
Posts: 350
Joined: Tue Aug 02, 2011 9:41 am

Re: Immunotherapy trial for those NED

Postby ktwmn » Wed Jan 18, 2017 11:20 am

My thoughts exactly Plastikos! And also about the immuno vaccine available for stages I-III...
Dx 7/11, Stage IIIc CC
12 txs Folfox 8/2011-2/2012
MSS, KRAS-mut G12D
NED until 3/2015, mets to liver and peritoneum
April-December 2015: 15 txs folfiri+avastin
Liver mets resolved; pelvic met remains
January-May 2016: folfox+avastin; allergic rxn to oxi
June-August 2016: 5FU+avastin
October 2016: looking into immuno trial
January 2017: maintenance chemo xeloda + avastin

mariane
Posts: 704
Joined: Sun Sep 13, 2015 6:16 pm

Re: Immunotherapy trial for those NED

Postby mariane » Wed Jan 18, 2017 11:26 am

This study was announced and started (?) in 2014 for solid tumors. Do you know about any success with this one?
mom of now 14 years old twins, dx @ 40 in 6/2015 with upper rectal cancer, 10+ liver mets, CEA 140
chemo: 8/2015 - 10/2016 - 4xFOLFIRINOX, 2xFOLFOX, 8xFOLFIRI, 10x5FU, HAI pump -12xFUDR
4 surgeries, complete pathological response
CEA<2 since 10/2015
NED since May 2016

I praise God for every day with my family!

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Maia
Posts: 2443
Joined: Fri Aug 24, 2012 8:00 am

Re: Immunotherapy trial for those NED

Postby Maia » Wed Jan 18, 2017 11:52 am

mariane wrote:This study was announced and started (?) in 2014 for solid tumors. Do you know about any success with this one?


They have not published so far, that I know, Mariane. The trial actually started in the second half/ end of 2015 (was presented at ASCO on 2015). Had other trial# back then, and the planned primary completion date twice, at least: it changed from 1 Dec 2016 to 1 Dec 2017, and later to 1 Apr 2018. I don't know if that means they are doing well, I hope so. : )

mariane
Posts: 704
Joined: Sun Sep 13, 2015 6:16 pm

Re: Immunotherapy trial for those NED

Postby mariane » Wed Jan 18, 2017 1:45 pm

Thank you Maia!
This one is hard to evaluate. As you wrote it started finally a year ago. They need to check the % of those NED after 2 years and 2 years is still a short time.... The fact that it worked on apes is encouraging.
mom of now 14 years old twins, dx @ 40 in 6/2015 with upper rectal cancer, 10+ liver mets, CEA 140
chemo: 8/2015 - 10/2016 - 4xFOLFIRINOX, 2xFOLFOX, 8xFOLFIRI, 10x5FU, HAI pump -12xFUDR
4 surgeries, complete pathological response
CEA<2 since 10/2015
NED since May 2016

I praise God for every day with my family!

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Marylandmaniac
Posts: 234
Joined: Wed Jun 29, 2016 6:22 pm

Re: Immunotherapy trial for those NED

Postby Marylandmaniac » Wed Jan 18, 2017 1:51 pm

Thanks for posting this! I am actually thinking about this. I had surgery Dec 14th and am doing my follow up chemo now. Should be done by mid March. I am meeting Dr. John Marshall who is Director of Otto J. Ruesch Center for the Cure of Gastrointestinal Cancer and chief of oncology at Georgetown on Feb 21st. I will ask him about this. I am about 2 hours or so from Philly but would be nicer if Georgetown has something similar since it is closer.

I am all for doing anything to make sure I Stay free of this! Plus helping science would be pretty cool too.
DX 6/29/16 7 cm tumor, 10 cm fr av
CT scan ab,MRI abdomen - 9mm spot on liver,CT scan of chest lungs clear
Special staging MRI - clinical staging stage 3b - T3N2M0 (unless spot proves to be met)
8/11 PET scan - spot lit up not nodes
8/16 Port in, 8/17 liver microwave abltn - spot gone
8/23 6 rds FOLFOX started
PET scan 10-13 43% red of tumor and no mets shown
Exam tumor greatly reduced. Surgery 12-14-16.
Clear margins, 7 out of 13 nodes positive. Tumor 2.1 cm
Kras wild, MMS, not MSI. 6 more rds FOLFOX

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Maia
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Joined: Fri Aug 24, 2012 8:00 am

Re: Immunotherapy trial for those NED

Postby Maia » Wed Jan 18, 2017 2:20 pm

That's so great, mm! :)
(BTW, I'm CeeCee Walker at The Clinic : ) )

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Marylandmaniac
Posts: 234
Joined: Wed Jun 29, 2016 6:22 pm

Re: Immunotherapy trial for those NED

Postby Marylandmaniac » Wed Jan 18, 2017 3:08 pm

Maia wrote:That's so great, mm! :)
(BTW, I'm CeeCee Walker at The Clinic : ) )


HI there!! I just sent you a friend request. I am Rene :)
I sent the clinical trial coordinator an email. I figure I may as well start the ball rolling and get some info now.
DX 6/29/16 7 cm tumor, 10 cm fr av
CT scan ab,MRI abdomen - 9mm spot on liver,CT scan of chest lungs clear
Special staging MRI - clinical staging stage 3b - T3N2M0 (unless spot proves to be met)
8/11 PET scan - spot lit up not nodes
8/16 Port in, 8/17 liver microwave abltn - spot gone
8/23 6 rds FOLFOX started
PET scan 10-13 43% red of tumor and no mets shown
Exam tumor greatly reduced. Surgery 12-14-16.
Clear margins, 7 out of 13 nodes positive. Tumor 2.1 cm
Kras wild, MMS, not MSI. 6 more rds FOLFOX

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juliej
Posts: 3114
Joined: Thu Aug 05, 2010 12:59 pm

Re: Immunotherapy trial for those NED

Postby juliej » Wed Jan 18, 2017 7:48 pm

I noticed the "inclusion criteria" has a restriction of 6 months since last treatment (see below), but it sounds very interesting! I wonder what they consider "high risk of relapse" - it's not defined.
Subjects with breast, lung or pancreatic carcinoma who are at high risk of relapse post definitive therapy at least 4 and no more than 24 weeks from completion of definitive therapy at the time of signing informed consent as described below for each indication.
Stage IVb, liver/lung mets 8/4/2010
Xelox+Avastin 8/18/10 to 10/21/2011
LAR, liver resec, HAI pump 11/2011
Adjuvant Irinotecan + FUDR
Double lung surgery + ileo reversal 2/2012
Adjuvant FUDR + Xeloda
VATS rt. lung 12/2012 - benign granuloma!
VATS left lung 11/2013
NED 11/22/13 to 12/18/2019, CEA<1

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Marylandmaniac
Posts: 234
Joined: Wed Jun 29, 2016 6:22 pm

Re: Immunotherapy trial for those NED

Postby Marylandmaniac » Thu Jan 19, 2017 9:56 am

juliej wrote:I noticed the "inclusion criteria" has a restriction of 6 months since last treatment (see below), but it sounds very interesting! I wonder what they consider "high risk of relapse" - it's not defined.
Subjects with breast, lung or pancreatic carcinoma who are at high risk of relapse post definitive therapy at least 4 and no more than 24 weeks from completion of definitive therapy at the time of signing informed consent as described below for each indication.


I sent an email yesterday so if I learn anything more I will post here.
DX 6/29/16 7 cm tumor, 10 cm fr av
CT scan ab,MRI abdomen - 9mm spot on liver,CT scan of chest lungs clear
Special staging MRI - clinical staging stage 3b - T3N2M0 (unless spot proves to be met)
8/11 PET scan - spot lit up not nodes
8/16 Port in, 8/17 liver microwave abltn - spot gone
8/23 6 rds FOLFOX started
PET scan 10-13 43% red of tumor and no mets shown
Exam tumor greatly reduced. Surgery 12-14-16.
Clear margins, 7 out of 13 nodes positive. Tumor 2.1 cm
Kras wild, MMS, not MSI. 6 more rds FOLFOX

Maelleous
Posts: 127
Joined: Tue Nov 01, 2016 8:13 am
Location: FL

Re: Immunotherapy trial for those NED

Postby Maelleous » Fri Jan 20, 2017 5:35 am

Thank you Maria, I am def going to look into this, as this has a lot of potentail. Going to email them now!
M 35 yr
DX Rectal Cancer, 10/16 (symptoms Feb 2016)
Dx stage 2 - Surgery Oct 25 201 Loop ileo w/ j-pouch
Close margins within 1mm
9/38 lymph nodes involved on path / Stg IIIc,pT4, pN2 B, p.M0. MSS, K‐ras, NRAS, no mutation
Started Folfox - 3rd Treament, Dec 30th 2016 Cardiac Arrest - Lucky to be part of the 6% to survive!
S-ICD installed / Port Removed
Vaccine Clinical trial at UPMC - last shot June 2017
Reversal 8/1/17 - Praying this is it!
Still NED


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