Tuesday, June 10, 2014

MLN0128 clinical trial

I have been fortunate to be able to join two clinical trials with this disease. The first one was 9 years ago when I joined a phase 3, dose-dense clinical trial. Phase 3 means that was randomly assigned to a group. The arm I was assigned to was IV Cytoxan and Adriamycin every two weeks (with Filgrastim for neutropenia in-between) for 12 weeks followed   by 6 weekly doses of Taxol.

When metastases was diagnosed after 8 years NED, I was taking the AI, Femara as well as Prolia for my bones. The treatment now notched up to Aromasin (exemestane), Faslodex and Xgeva. After 11 months on that regimen, a scan showed mets to the liver- four spots.
My treatment choice was a standard treatment or a clinical trial. I chose a clinical trial. I am a scientist. That was not even a decision that I needed time to think about.

The clinical trial is phase 1 b. This is the scary phase of a drug that is not yet FDA approved and even the dosage is not completely standardized. Phase 1 also means that I was not randomly assigned into a group, but openly assigned. My group is Faslodex monthly shots and 5 mg of the drug, MLN0128 every day. The drug is a TORC1/2 kinase inhibitor. It has been shown to work in the lab by inhibiting cancer growth in a number of mutations.

The study protocol calls for following 126 women with advanced breast cancer for as long as the drug works,  with follow ups after you stop taking the drug for any reason. Of course, if the cancer shows any progression while on the drug, you are off the clinical trial.

After signing all the consents I was ready to go.   Well, not quite. On day one I went for a consultation to see if I was  fit enough for the clinical trial. I was. I signed. I then had to wait out two weeks in the wash-out period when I was not allowed any drugs. Two weeks later I went for my first round of treatment. But first I had to sign the updated protocol because of minor changes to the procedure and a brand new list of possible side effects. That got my attention. The side effects deserve their own little celebration so I will discuss them later.
The protocol is as follows:
Every month I continue with the Faslodex (two large intramuscular shots in the rear) and Xgeva (one small burning shot into the fat of the stomach). I no longer take the Aromasin but instead take MLN0128 every morning at about the same time of day. Every two weeks it was back to the hospital to be evaluated by a doctor or nurse, have EKGs done and have more blood drawn.

As for the procedure:
Every morning the first thing that I do is prick my finger to test my blood sugar. I am not allowed anything to eat  or drink for at least eight hours before that – besides plain water. That finger prick procedure took some getting used to. I am not sure that the research coordinator explained it clearly. The next time I went on a visit I made sure that I spoke to a phlebotomist who has diabetes and she is a finger-pricking expert. I don’t know if I have had, or really even want enough practice to be an expert, but I have definitely improved and seldom have to prick more than once anymore.

The drug is to be taken with food. And lots of water. I think that is an effort to reduce nausea. If it is, it does not work for me.

The long list of side effects were given in order of most to least common.


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