On the QT(c)

All I could think of was the classic movie, "LA Confidential". Remember Danny DeVito, as gossip reporter Sid Hudgens, saying things were "off the record, on the QT and very hush-hush"? No one knows from where the slang phrase "on the QT" originated (clearly a contraction of "on the quiet"), but for me, my QTC was causing abject chaos. One's QTC is a time interval measured in your EKG. An absolute criteria for inclusion into my study was a QTC of < 450. Knowing this, I had long ago sent MSKCC my cardiogram documenting a QTC well below 450.

BUT, as it was over a month old (by one week), the always-by-the-book MSKCC had me repeat my EKG. The first few readings showed QTC's of between 460-470!!! They had me run up the block, then climb stairs, then simulate bicycling in the air, but the best we could do was 452. The EKG tech was patient, persistent and very apologetic. The research nurse then paged a cardiology fellow to "hand read" my study.

My study participation was on hold and in jeopardy. My doctor agreed to let me go through the consent process and sign the papers, but there would be no medication unless or until the EKG issue was resolved. The plan was to head home, mired in uncertainty, and hope an Evanston EKG would be normal. Why electrons would be expected to behave differently in the Midwest was quite beyond me.

As I sat in my hotel room awaiting scan #97, the research nurse called me and excitedly told me the cardiologist's reading of my QTc was 432! 

So in two weeks, I return to get my new drug. Phew!

Clinical Trial--- here I come.

It is a long way from the gorilla habitat of the Virunga mountains of Central Africa to the Upper East Side of Manhattan, but old blogs never die.

I am here to begin participation in a Phase II Clinical trial of a new drug called: ARN-509. What does a Phase II trial entail? Here is a brief description lifted from a government website.

What is a clinical trial and what are its phases?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

Over the course of the next several days, I will have blood drawn, have seven scans and go through the formal process of informed consent for this trial. The latter involves seeing my Sloan Kettering medical oncologist and also his research team. They will review the study protocol, discuss the currently-known risks, benefits and alternatives to this treatment plan and have me sign a lot of stuff. Entering a clinical trial seems to me somewhat akin to buying a gun (irony unintended). Once you sign the papers, you have to wait a week before they give you your medicine. This is imminently sensible as it allows the patient to step away from the "pressure" inherent in sitting before care-givers and also allows for the information presented during the informed consent process to sink-in and percolate. For me this means I have to fly back to NYC next week. Oh well.

Anyway, I will write more once I have been through the informed consent process. I have given the speech (or a similar one) a million times myself. I am curious about what it will be like for me. Also, more on ARN-509 to follow.