Clinical Trials here we come...hopefully

[flyboy22]

So, as you can see from my updated signature...things are not exactly improving. In fact, it's the opposite.

After 4 rounds of Folfox + Avastin my wife had scans in mid-March.

Sadly, it appears that Folfox had zero affect. There are new and increasing size of numerous bilateral lung nodules compared to January scan. For example, two that were .6 cm in Jan are now 1 cm.

The lymph nodes are stable or minimal increase: e.g. left para-aortic node was 1.6 x 1 cm in Jan, now it is 1.7 x 1.2 cm.

Because she had persistent headaches, Onc ordered MRI to rule out brain mets. Thankfully, those results were negative for brain mets.

So because she's KRAS mutant, we only have longsurf and stivarga left. But our onc doesn't think lonsurf will be effective since it is similar to 5-FU, and 5-FU doesn't seem to work anymore. (Lonsurf has a tri-fluoro cluster in place of the single fluoro cluster at the same spot of the aromatic hydrocarbon.)

Basically, we're down to stirvarga and clinical trials. Oh and about 6 months.

We decided to go after clinical trials and wait on stivarga for a bit. Especially since my wife is still asymptomatic and at a 0 on the performance scale. (It is with utmost love that I declare my wife a is zero! )

My wife had blood drawn and sent to Guardant 360 for a full genetic tumor profile. Plus MD Anderson did the same with tumor samples from hemicolectomy and supraclavicular lymph node biopsy.

Results are that after testing for 100+ genetic mutations, her tumor only exhibits three: KRAS (which we knew already), APC, and TP53.

Based on my reading, it appears APC with both KRAS and TP53 isn't very common...and also has more negative outcomes.

Still, thanks to Dr. Tom's (DK37) MSS clinical trial finder, i've been combing through the spread sheet to identify a few possible trials.

Right now our clinical research doc at MDA wants her to go through a trial not on Dr. Tom's list.

It's a test of LTT462 which targets the ERK protein which is downstream from KRAS in that signaling pathway. The identifier is NCT02711345. https://www.clinicaltrials.gov/ct2/show/NCT02711345

If anyone knows anything about LTT462 or that trial, please let us know. We can't find much.

Which is partly why we're not very excited about it. So we're probably going to pass.

The Checkmate 142 clinical trial (NCT02060188) is also at MDA, but they don't have openings at the moment. They are on hold for safety observation for the previous patients that went through earlier this year. The trial coordinator expects it to reopen in June though, so we're probably going to wait for that. It's a nivolumab test in combo with ipilimumab and cobimetinib (MEK inhibitor) for MSS patients. I'm hopeful the MEK inhibitor can produce positive affects against the KRAS mutation.

We're also hoping to hear back from the trial coordinator for the Atezolumab + cobimitinib + Avastin trial at MDA (NCT02876224). I don't know much about that one, but it struck me as better potential than the LTT462.

Meanwhile, we also have family reunions lined up in July mostly for her side of the family, and of course we want to make sure she's there since it likely will be her last time.

So it's tough not having any treatment right now, trying to find the best match for a clinical trial, but unsure if you'll even get accepted to the openings, should they have any.

Anyway, I'd love to hear anyone's thoughts on these or other clinical trials, preferably at MDA.

Plus, any experiences with Stivarga would be helpful too, since we're likely to do that at some point as well.

Thanks again for your help. Keep up the good fight!

[stu]

Hi,
Just popping this back to the top. I am not going to be any help to you on this one . You sound very knowledgable yourself and I sincerely hope she gains control with a trail. Your a great support to her.
Much love to you and your wife,
Stu

[Achilles Torn]

Hey flyboy,

Sorry to hear about the progression. I don't have information on the Trials, but I wanted to mention there has been more recent research on High Dose IV vitamin C that shows it may be somewhat effective against KRAS mutation. This is something you can do through a naturopath clinic. You have likely looked into this already but I thought I would mention it. There are a few anecdotes around about it as well on this site and Colontown.

Wishing you and your wife the best.

AT

[Lee]

BeansMama has had great success with Keytruda. If you read her signature line, all other standard chemo treatments have failed her. Here is her most recent thread.

viewtopic.php?f=1&t=57882

Are you familiar with with Sleen's journey. At one time, I believe she was given months to live yet she is NED today. Here is her on going thread which has also helped others.

viewtopic.php?f=1&t=49736

Hope this helps,

Lee

[Maia]

Atezolumab + cobimitinib + Avastin trial at MDA (NCT02876224). I don't know much about that one, but it struck me as better potential than the LTT462.

Yes. Remember that the trial that has better published data regarding response, for MSS, is the one with atezo and cobi, and all minus 1 participants were KRAS mutant. Avastin just might want to add a welcomed punch to the whole --like it adds it for those MSI-high who don't respond to anti PD-L1/PD-1 alone.

I wanted to mention there has been more recent research on High Dose IV vitamin C that shows it may be somewhat effective against KRAS mutation. This is something you can do through a naturopath clinic. You have likely looked into this already but I thought I would mention it. There are a few anecdotes around about it as well on this site and Colontown.

There is also a TRIAL in USA, for mCRC BRAF and KRAS mutated, finally, open just days ago:
NCT03146962
High Dose Vitamin C Intravenous Infusion in Patients With Resectable or Metastatic Solid Tumor Malignancies

This is a single arm, 2-cohort, open-label trial of high dose Vitamin C intravenous infusion in subjects with solid tumor malignancies who are eligible for resection (cohort A) or with KRAS or BRAF mutant metastatic cancer who have received prior systemic treatment (cohort B).

Condition
Colorectal Cancer
Pancreatic Cancer
Lung Cancer
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B).
Protocol reproducible with naturopath help, yes. https://clinicaltrials.gov/ct2/show/NCT03146962

[Maia]

I'd love to hear anyone's thoughts on these or other clinical trials, preferably at MDA.

Are you interested in trials at MDA because you like/trust the facility, or because of the Texas area? There is other interesting trial in Texas, which is not at MDA: https://clinicaltrials.gov/ct2/show/NCT03010176 STING agonist + pembro. Check the MSS finder --in my signature too -- and more to read, if you're interested, here: https://drive.google.com/drive/folders/ ... sp=sharing

[flyboy22]

Atezolumab + cobimitinib + Avastin trial at MDA (NCT02876224). I don't know much about that one, but it struck me as better potential than the LTT462.

Yes. Remember that the trial that has better published data regarding response, for MSS, is the one with atezo and cobi, and all minus 1 participants were KRAS mutant. Avastin just might want to add a welcomed punch to the whole --like it adds it for those MSI-high who don't respond to anti PD-L1/PD-1 alone.

I wanted to mention there has been more recent research on High Dose IV vitamin C that shows it may be somewhat effective against KRAS mutation. This is something you can do through a naturopath clinic. You have likely looked into this already but I thought I would mention it. There are a few anecdotes around about it as well on this site and Colontown.

There is also a TRIAL in USA, for mCRC BRAF and KRAS mutated, finally, open just days ago:
NCT03146962
High Dose Vitamin C Intravenous Infusion in Patients With Resectable or Metastatic Solid Tumor Malignancies

This is a single arm, 2-cohort, open-label trial of high dose Vitamin C intravenous infusion in subjects with solid tumor malignancies who are eligible for resection (cohort A) or with KRAS or BRAF mutant metastatic cancer who have received prior systemic treatment (cohort B).

Condition
Colorectal Cancer
Pancreatic Cancer
Lung Cancer
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B).
Protocol reproducible with naturopath help, yes. https://clinicaltrials.gov/ct2/show/NCT03146962

Maia, is there a publication or report I can read about the NCT02876224 trial and the success with KRAS mutants?

The vitamin C infusion trial sounds interesting, but to answer you're other question, we prefer MDA because that is where our Onc is at. We live in Houston, and with 3 young kids, it's much easier logistics wise to do trials here.

That's not to say we wouldn't consider other locations, but there is a strong preference to go to MDA.

Also, I only found these trials mainly because of Dr. Tom's MSS trial finder in his and your signature. I don't know if you helped him curate it, but I'm super appreciative to both of you for helping everyone here find clinical trials. It's very overwhelming.

Why is the STING agonist trial interesting? Is there a publication about it I can read?

[flyboy22]

Thanks everyone for the kind words and comments. We'll keep fighting.