Phase I - Hit Me Hard? I Think Not!

As most of you know, this past Monday, December 9, 2013, I started my new treatment. This treatment is a Phase I Experimental Trial. The trial I am participating in is called – ready for this? It’s an awesome name – OMP 18R5. Impressive right? Such a cool name! The whole title of the study is actually called: A Phase I Dose Escalation Study of OMP-18R5 in Subjects with Solid Tumors (18R5-001).

“This is an open-label Phase 1 dose escalation study of OMP-18R5 in subjects with a solid tumor for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit.”* 

Basically, as my research paper says, 

“Many current cancer therapies often produce an initial reduction in tumor size but may not have long-term benefits. One possible explanation for this is the presence of a specific type of cancer cell known as a cancer stem cell. Cancer stem cells represent a small part of the tumor but are believed to be responsible for much of the growth and spread of the cancer. Cancer stem cells may also be more resistant to traditional types of therapy, such as chemotherapy and radiation therapy.

The purpose of this study is to test the safety of a new experimental drug, OMP-18R5. OMP-18R5 is a humanized monoclonal antibody and was developed to target cancer stem cells.” ** 

All in all, it should actually be attacking my cancer cells at the root of it, unlike most chemotherapy and radiation therapies which hit it at the outside and work from there. The upside of this is that it’s not targeting me. It’s targeting my tumors. Meaning, it’s not hitting my white blood cells, or anything, not putting me at risk of infections like before!

Monday was a very long day for mom and I. I had a blood draw to see what my normal DNA looks like before the treatment. I then had an appointment with the doctor of this trial, and proceeded to have treatment for the next 7 hours.

This treatment is very different from the last chemo treatment I was on before. Instead of receiving 4 different regimens, fluids before, during and after, along with oral pills for vitamins, and anti-nausea through my IV, this time, my regimen is only running for 30 minutes. The only thing is, I not only am having my port accessed, but I also need an IV in my arm to put the regimen through. See my port is being used for blood draws. I have a blood draw and vitals before the chemo is pushed through, and then proceed to have another blood draw 15, 30, and an hour afterward, along with vitals and that continues for another 3-5 hours afterwards. 

Upside? I shouldn’t be having any nausea, no tiredness, maybe a little bit of muscle ache, but nothing else.

Downside? I could lose bone density.

Fix to that? A week before, I had CT scans and Bone Density tests and an injection to level my bone density and maintain it at the level it is at already, plus every day I take 1000CC of Vitamin D3 and 1250CC of Calcium twice a day.

Now Monday, that was a fun day, as I didn’t know I was going to have a normal IV in my arm. If I had known this before, I would have pounded down tons of water for 3 days leading up to Monday. So instead of knowing this, drinking tons of water and only getting ‘stabbed’ once, I was stabbed 2 times by one nurse in my left arm, had someone else who is better with tricky veins in the same arm, and then tried the other arm for a 4^th stabbing; which finally worked...after tons of digging around. We have determined that although I a people person and get along well with others, my veins on the other hand are not people oriented and are very shy and simple don’t play well with others.

The day went by smoothly, and Tuesday and Thursday (yesterday) I returned for follow-up blood draws. Once a week, every week I have to go back and get blood draws and meet with my doctor to see how I’m doing and how the chemo is affecting me.

Every 3 weeks I receive this treatment. But next time I receive this treatment, instead of being held at the hospital for 7 hours, I only have to be there for 3 hours – the first to get vitals and put the chemo in, and the other 2 to administer how I’m responding to it and have a few blood draws. Much shorter days! :D

I forgot to tell about Monday appointment with my doctor. The results of all my MRIs, CT Scans and Bone Density tests came back from the week before. My doctor said, 

“There was no growth in the tumors!” 

Woah there! NO GROWTH? While I was on chemo therapy for those 2 months before, my tumors grew a ton, almost twice their sizes, but in this last month there was no growth? MIRACLE! Granted, they haven’t shrunk….YET, but they will!

Praise the Lord that they haven’t grown at all! Thinking about that has made all of my days so much better than before!

*Clinical Trials - A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors http://clinicaltrials.gov/show/NCT01345201

**University of Michigan Consent To Be Part Of A Research Study (my paper consent form)