A Potential MSS-CRC Immunotherapy From an AIDS Drug Start: The CCR5 Receptor Antagonist Maraviroc

[DK37]

Today’s Blog Post is a science one – but one I recommend all MSS-CRC patients read and consider discussing with their MD/medical team for medical advice: “A Potential MSS-CRC Immunotherapy From an AIDS Drug Start: The CCR5 Receptor Antagonist Maraviroc”

Some excerpts:
This study was very small, only 14 (!) MSS-CRC patients – and small studies sometimes do not confirm in later larger clinical trials. But signs of clinical efficacy were seen in a significant proportion of the patients including objective responses. It is also intriguing that the study showed that Maraviroc could be given both as a monotherapy as well combined with multiple types of standard of care chemotherapy for CRC – in both cases showing objective responses.

The confirmatory Phase 2 trial will be starting soon in Germany (January, 2017). The current Phase 1 trial data may only be preliminary but unfortunately the prognosis of many Stage IV MSS-CRC patients may not allow a lifespan long enough to wait for the German Phase 2 trial results to be known.

Looking at the commercial availability of Maraviroc and its preliminary clinical profile in MSS-CRC patients, it is likely that many stage IV CRC patients will be seeking the medical advice of their oncologists on its potential off-label use, especially as they begin to run out of standard of care treatment options. In my own case, my standard of care options are dwindling and my life is on the line. In that situation, it is an easy decision in my mind to ask for medical advice from my oncologist. The outcome of these medical advice discussions will be very patient specific – but I for one, know I will be having that discussion!

Recycling is good for society, good for the planet, and in this case it may be good for MSS-CRC patients!

https://adventuresinlivingterminallyopt ... maraviroc/

[Maddielolo]

Very interesting. and given toxicity, clinical response, and approved med, this may be better option than trials as first option following conventional chemo. Any duration reported study?

[DK37]

Very interesting. and given toxicity, clinical response, and approved med, this may be better option than trials as first option following conventional chemo. Any duration reported study?

Edit:
I missed the data the first read through.
Keep in mind this is in VERY small patient numbers, here is the survival data - all patients having exhausted all standard of care before trial:

7.32-month overall survival (95% confidence
interval, from 6.91 months to infinity).
-DK

[dudette]

WHOA! Thanks for highlighting this study.

I have an appointment lined up with NCT in Heidelberg the week after next. Initially it was only meant as a general discussion whether they will take me in as their patient (I really need an oncologist or even better an oncological team that has a treatment strategy that goes beyond my current chemotherapy) but it came about that I will also be screened for two trials.

I'll be on the phone tomorrow to ask about the Phase 2 trial and check when they start screening patients. I am so excited that you brought this up. Thanks

[DK37]

WHOA! Thanks for highlighting this study.

I have an appointment lined up with NCT in Heidelberg the week after next. Initially it was only meant as a general discussion whether they will take me in as their patient (I really need an oncologist or even better an oncological team that has a treatment strategy that goes beyond my current chemotherapy) but it came about that I will also be screened for two trials.

I'll be on the phone tomorrow to ask about the Phase 2 trial and check when they start screening patients. I am so excited that you brought this up. Thanks

Great - could you please post in this thread what you hear back from the trial? (I might not see it if it is in a separate post & also that will keep news about this trial in a single thread for others to follow). Another fellow patient who has spoke to them I think last week said they told her they expected the trial to start in January.

Best of luck,

-DK

[dudette]

Just to say that I'm on the case.

Haven't heard back yet. Called, sent email. Will keep nagging them. And if need the principal investigator will receive a surprise visit from me in his office next Tuesday

[Maia]

Will keep nagging them. And if need the principal investigator will receive a surprise visit from me in his office next Tuesday

Hehehe. ˄˄˄˄˄ That's the attitude! : ))

[dudette]

Update:

received a brief email from principal investigator, Dr. Halama.

They are planning to roll out a few studies with Maraviroc - he didn't elaborate whether and what type of combination trials they'll be running. Recruitment is supposed to start in February 2017.

He suggested that in the meantime I should still consider participating in other studies since recruitment might be pushed back.

Patience seems to be the name of the game. But at least something is cooking.

[H is for Hawk]

I tried to get my integrative doctor to prescribe off-label Maraviroc to me, but he stongly advised against it. Normally he has been supportive for off-label use of other drugs, such as metformin. He said the FDA requires the manufacturer to label the boxes with the ominous black box warning, in this case it is:

"Black Box Warning:
HEPATOTOXICITY has been reported with Maraviroc use. Evidence of a systemic allergic reaction (e.g. skin rash or elevated IgE) may occur prior to the development of liver toxicity. Patients with signs of hepatitis or allergic reaction should be evaluated immediately."

One has to weigh the risk of liver damage with the possible benefit of tumor shrinkage. There is conflicting advice. The Maraviroc clinical trial in Heidelberg, Germany (NCT01736813) write-up on clinical trials.gov is more positive, where the site investigator states Maraviroc is "a drug has little side-effects and toxicities even on long term treatment".

[DK37]

I tried to get my integrative doctor to prescribe off-label Maraviroc to me, but he stongly advised against it. Normally he has been supportive for off-label use of other drugs, such as metformin. He said the FDA requires the manufacturer to label the boxes with the ominous black box warning, in this case it is:

"Black Box Warning:
HEPATOTOXICITY has been reported with Maraviroc use. Evidence of a systemic allergic reaction (e.g. skin rash or elevated IgE) may occur prior to the development of liver toxicity. Patients with signs of hepatitis or allergic reaction should be evaluated immediately."

One has to weigh the risk of liver damage with the possible benefit of tumor shrinkage. There is conflicting advice. The Maraviroc clinical trial in Heidelberg, Germany (NCT01736813) write-up on clinical trials.gov is more positive, where the site investigator states Maraviroc is "a drug has little side-effects and toxicities even on long term treatment".

During the required MD discussions for prescription(I intended for patients to have those discussions with their medical ONCOLOGIST not with a naturopath - that is why I very specifically wrote: "Looking at the commercial availability of Maraviroc and its preliminary clinical profile in MSS-CRC patients, it is likely that many stage IV CRC patients will be seeking the medical advice of their oncologists on its potential off-label use, especially as they begin to run out of standard of care treatment options. In my own case, my standard of care options are dwindling and my life is on the line. In that situation, it is an easy decision in my mind to ask for medical advice from my oncologist. The outcome of these medical advice discussions will be very patient specific – but I for one, know I will be having that discussion!"), I think it has to weighed against the likely patient population, a Stage IV CRC patient who has exhausted all standard of care options and quite frankly is facing death. Liver panel monitoring will be required. It should be treated as an oncology drug not as a less strong off-label medicine like metformin. That being said, the less strong off-label drugs like metformin have not generated the strong objective responses since in the preliminary small maraviroc trial - so they are really apples and oranges (in terms of both potential toxicity and potential efficacy) and should be treated as such...

[CRguy]

- so they are really apples and oranges (in terms of both potential toxicity and potential efficacy) and should be treated as such...

AND, my addendum here, whose emphasis is underlined and hopefully UNDERLINES DK37's post

"... in the context of an informed consent, doctor/patient relationship with an accredited Oncological professional, who KNOWS the relevant details of their own patient's exact situation, in the context of existing medico-legal efficacy and reality. "

AND not just .... well folks YOU figure out the rest
BUTT I am / have also been an "alt" / integrative practitioner and when I was Dx
I stuck with existing medical practices ..... WHY ?
do you feel me biting my tongue folks ?
I am.

DK37 .... Harmony bro'
ALWAYS on the Journey with you
YOU ROCK buddy

CR

[DK37]

- so they are really apples and oranges (in terms of both potential toxicity and potential efficacy) and should be treated as such...

AND, my addendum here, whose emphasis is underlined and hopefully UNDERLINES DK37's post

"... in the context of an informed consent, doctor/patient relationship with an accredited Oncological professional, who KNOWS the relevant details of their own patient's exact situation, in the context of existing medico-legal efficacy and reality. "

AND not just .... well folks YOU figure out the rest
BUTT I am / have also been an "alt" / integrative practitioner and when I was Dx
I stuck with existing medical practices ..... WHY ?
do you feel me biting my tongue folks ?
I am.

DK37 .... Harmony bro'
ALWAYS on the Journey with you
YOU ROCK buddy

CR

Cheers CR!
-DK