Clinical Trial Update - Appt. with Dr.

[NWgirl]

So a few comments to share with anyone who is interested in following how my trial is going.

Despite the horrific side effects from round #1, I am determined to give it another go. I met with my doctor and research nurse yesterday for what I thought would be a short office visit and blood draw - turned into an all day ordeal.

I asked my doctor if staying overnight in the hospital was an option and he said yes (I think it's required now). I will definitely spend the night in the hospital after I receive round #2 next Tuesday. Not only will I be staying in the hospital, but it's my understanding that all new participants who sign up for the trial will also be required to spend the night in the hospital until we know whether this was a "just me" type thing, or is to be expected for all participants. So to those who sign up after me - you're welcome!

I will be given anti nausea and anti diarrhea meds before the infusion. They don't know yet if they can give me Emend as it was designed to work in conjunction with a steroid, and the steroid would interfere with the test drug. So my doctors are researching whether there have been any studies on Emend and its effectiveness if used without a steroid.

They checked my blood work and my phosphorous and magnesium levels are back to normal - so that's all good. However, something else was off in my blood work (can't remember what), so my doctor insisted I stay for a CT scan to rule out pancreatitis. They said this reaction is not uncommon in immunotherapy drugs, but they have to be ultra conservative and cautious and make absolutely sure my pancreas was okay - it is. All good.

I have a small rash on my upper back that itched - so they're testing me for shingles. Again - just being super cautious.

They did another EKG to make sure my heart was okay - it is.

My back, where I have tumors, has been very painful. The research nurse said this may be a positive sign - that the drug is attacking the tumors causing inflammation. Wouldn't that be amazing?

I'm ready to go for round #2 next Tuesday. For those who want to know - this is the name of test drug - MGD007, MacroGenics' DART for Colorectal Cancer

I'm scared, I'm very cautiously hopeful and well, mostly just scared. I still have a lot of fatigue, minor nausea and lots of pain. Lets just hope like hell that the pain is a good sign. I'm also kind of stunned a bit in that I'm REALLY contributing to furthering scientific research. Yeah, I'm a lab rat - but I'm a very well treated lab rat. Because of my horrible reaction, EVERYONE has to spend the night in the hospital. They're taking my reactions very seriously. That's pretty damn impressive to me. Despite what my final outcome may be, I feel like I'm doing something. I'm trying.

[kirac]

Thanks for the update. I hope to god the tumors are shrinking.

[ams5796]

You're right, Belle, it all sounds very impressive. You are an extremely brave "lab rat" and I thank you for that. I'm taking it as a great sign that you have back pain. I love that you're hopeful about this...I am too. And, its' a good feeling. Please keep us updated.



Ann

[bitchslapped]

Takes "moxie" to do what you're doing considering, no kidding. They'll probably lower the dose, don't you think? I hope the trial is paying for your hospital stay. Yes, you really are contributing to furthering scientific research that could help you and others even on this forum. Kind of mind boggling, isn't it?

Good luck to you! Don't be too scared as I'm sure they are going to be very careful with you and monitor you very closely.

Bitchslapped

[DK37]

Belle - as a fellow Stage IV mCRCer who reads posts often but has never posted before, I thank you from the bottom of my heart for helping to test new medicines not only for your own good but for the good of everyone! THANK YOU!

Although I am a patient, I am also by chance a PhD Oncology researcher and I want you to know that the MGD007 trial is way at the top of my list of "scientifically great idea" trials that I am excitedly following. Excited for the possibility that it may help patients who really need it, excited because I love science & its science is trully exciting, and excited to follow because I plan to be jumping into mCRC immunotherapy clinical trials myself one of these days when my tumors become chemo-resistant - so I am tracking all the best looking ones for my own possible future use.

As an oncology researcher for 20 years, I can honestly say this is the most exciting time period in oncology new therapeutics reserach (in particular immunotherapies) in decades. There is true excitement in the air at conferences as scientists have begun to more openly whisper the possibility of the "C word" - the C word that ends in -ure. I honestly believe they will figure out tricks to either cure or at least produce very long term remissions in mCRC within my wife's lifetime - I am right now crossing fingers that it will happen in my lifetime

God bless you and to health!

Tom

[Voxx66]

As to Emend: I was given it yesterday though I refuse the steroids. I didn't know they were designed to be used in concert. I guess I will ask about that.

Still very impressed with your determination here. Major props.

[juliej]

You are officially my hero, Belle! Thank you for participating in this trial. I'm praying the pain in your back is a good sign. It sounds like they are keeping a close eye on you, which is what you want when you're out there on the frontier of medicine!

Here's a short write-up of MGD007 for those who don't know about it.

MGD007 is designed to redirect the body's T-cells, via their CD3 component, to target gpA33-expressing colon cancer cells. The glycoprotein A33 antigen, or gpA33, is found on over 95% of primary and metastatic human colorectal cancers, including cancer stem cells, which are thought to be responsible for tumor recurrence and metastasis.

[CRguy]

BELLE !!!!
...really glad they took the suggestion to keep you for observation after next round !!!!
wonder whose idea that was ????

All the testing and " being extra careful " is a VERY good thing my friend and YES ...what you are doing IS important for others as well as yourself.

If it's OK with you I linked the first topic of yours to this one so folks will have access to all you write as the trial continues !
Clinical Trial - Round 1 - Strike 1!

Mega Cheers and I-FIVES
CRguy

[Maia]

The data presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA, this past April 2014. The data was so good that 3 months later, in July, MacroGenics (the pharma) got cleared by the U.S. Food and Drug Administration (FDA) to proceed with this Phase 1 human clinical trial.
This https://drive.google.com/file/d/0B9Eo84 ... sp=sharing
The poster: https://drive.google.com/file/d/0B9Eo84 ... sp=sharing

DK37/ Tom: agreed. This is good, very good, very CRC-specific. And welcome and sorry you have to be here.

Belle: love you; keep strong!

[peanut_8]

Good luck Belle. I'm glad they are being so cautious. Here's to more back pain.
peeanut

[bitchslapped]

I'm going to second Maia's welcome to DK37. Glad you finally decided to speak up. The great thing about this forum is the "mixed bag" of people on here...the serious & the seriously whacky! (don't think NWgirl would mind me saying on her thread).

[hart2hart]

Belle ---

I concur with Julie J....."You are my Hero!"

Watch for my PM......OK?

Love, hugs and rainbows for you.......LOTS OF THEM!



Julie
Stamford, CT

[lauragb]

What you are doing is huge and scary and exciting. Thanks for sharing this. You are doing a service that I hope benefits you greatly! Although I am currently NED, I know people who are not. I think it is important for us to follow your progress for others and maybe for ourselves.

You are surrounded by light and love!
Laura

[chrissyrice]

Thank you for helping so many others with your going another round of clinical trials.

Hoping for a cure always.

[Lee]

Hi Belle,

Thanks for the update. Glad to hear the medical profession is taking extra precautions with your next dose.

You will be in my thoughts and prayers for no problems or issue with this next infusion. Enjoy this next few days off and keep us posting regarding next week.

A big (((HUG))) to you,

Lee