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Sutent or MDX-1106?

Posted by on February 8, 2011 in Immunotherapies (IL-2, IL-15, PD-1s, etc.), MDX-1106, My Health Updates, Sutent, Targeted Therapies (Sutent, Afinitor, Cabo, etc.) - No comments

 

clinical trialI’ve received some kind inquires about how my new treatment regimen on Sutent is going. It’s not. I’ve not yet made up my mind to go on Sutent, as Dena and I are considering a clinical trial instead. After spending several days debating the pros and cons of going on Sutent or the trial, talking to a few oncologists familiar with the trial, and probably some pretty unethical actions by my wife with the doctors at Johns Hopkins Sydney Kimmel Comprehensive Cancer Center, it looks like we may have secured one of the very limited slots in the trial. (I think there are about 70 slots nationwide.) It’s not a done deal, as we’re still trying to decipher whether our insurance will pay for it.

A clinical trial, you ask? What is this? A new drug? Do tell.

Well, I have two words for you: Pork brains in milk gravy. Tasty and delicious – but who knew of its miraculous healing powers? We’re going to megadose it.

Oh, wait. Dena says I’ve got the wrong trial.  Although promising in the cancer community, it is yet one more treatment therapy that does not work on kidney cancer. Fine. But there’s nothing to stop me from ordering it at the hospital cafeteria.

Turns out the trial we’re looking into is a Phase I trial of an experimental drug called MDX-1106. Which sounds like a section of the internal revenue code. Evidently they are going to inject me with bureaucracy. Which makes sense. Having worked in government, I am well aware of the capability of bureaucracy to kill anything.

The other theory is that it’s a new immunotherapy treatment. As with the IL-2 treatments I underwent last year, MDX-1106 seeks to jump start my body’s natural cancer-fighting cells, which are a healthy part of everybody else’s immune system except mine. Mine are on vacation. Or drunk. Something. Normally, when you have the flu or an infection, cellular proteins send out signals to kick the immune system into high gear to attack the foreign agents threatening your body. Once these foreign agents have been properly vanquished, the biological warfare stops, as other proteins send out signals for the immune system to chill out. Otherwise you’d feel continuously sick. The flu symptoms that make you so miserable aren’t due to the infection, per se, but to your immune system working doubletime. MDX-1106 blocks those cellular signals that tell your immune system to retreat. The thinking is that by inhibiting the proteins that tell my immune system to shut down, so to speak, we can trick it into kicking into high gear and, hopefully going after the cancer cells.

It’s a Phase I trial, which is the first of three primary stages of a clinical trial before the FDA will allow a drug to come to market. During Phase I researchers test just how much of the drug they can administer before it becomes too toxic. It usually goes something like this: “Try some more. Try some more. A little more … Oh, crap. Bring the next guy in.” (Just kidding. I’m told by the large pharmaceutical company hosting the trial that it’s all perfectly safe and I have nothing to worry about.) After determining the appropriate dosage amounts in a Phase I trial, a Phase II trial actually measures response – does it work?  If the answer is yes, then a Phase III trial is opened to a much larger sample of people and tested for longer periods of time. If the results show that the drug clearly produces a positive response, with reasonable side effects, the FDA will approve the drug for market.

You may wonder why I would bother with a Phase I trial when Sutent, a known quantity, is available. The answer is that my wife told me to. Also, while it is only a Phase I trial there is a lot of buzz in the renal cancer oncology community about this drug. I am actually looking at a Phase Ib trial, which is an expansion of the Phase I trial in which 16 kidney cancer patients tried the drug. Of those, 14 had some kind of response: one had a complete response (the holy grail of cancer therapies); four had partial responses, meaning some level of tumor shrinkage; nine had “stable disease,” meaning that the cancer did not progress during the treatment; and two saw progression, meaning the drug didn’t work. Statistically speaking, that 87% positive (shrinkage of tumors or stopping disease progression) to 13% negative.

It’s not an easy choice, though. Part of me wants to avoid losing time and move immediately to Sutent, a proven drug known to shrink tumors in an awful lot of kidney cancer patients. Part of me really wants to go with pig brains in gravy. And part of me wants to try this new immunotherapy drug that, outside of this trial, would be inaccessible to me.

We have an appointment with the oncology team at Johns Hopkins Thursday to discuss this trial in depth. We will make our decision at that time (provided there are no medical issues that would disqualify me from the trial, in which case there would be no decision to make.) And while I’m there I’m going to be eyeballing these doctors that Dena lobbied so vigorously. Something doesn’t seem right. Evidently they created a slot just for me. I know Dena can be persuasive, but …

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