Tuesday, June 28, 2011

Crummy news

The National Cancer Institute at the National Institute of Health just told me Meagan is ineligible for any clinical trial there. Their reason was not that there was evidence of active brain tumors, or that we had to wait three months from the last brain tumor treatment and be clean of disease in the brain. It was that Meagan's prior brain tumors bled (requiring the craniotomy and Cyberknife) and she suffered a seizure as a result of the brain irritation from the Cyberknife. "The seizures make her ineligible". So even if in her scan in thirty days she is clean upstairs, she can't do any of the promising melanoma trials occurring there, particularly the ones using a technique called adaptive cell therapy, where they harvest some of your T-cells, multiply them by the billions, mix them in a secret sauce, and then re-infuse them into your body after you have had 5 days of chemo, followed by another 5 days on Interleukin-2. It's still early research, but anecdotally they have seen more response using this approach and Dr. Kaplan was in favor of us pursuing this. Alas, it is moot at the NCI.
It's a pretty terrible disease when it's metastatic. It's worse if you have brain tumors because you are excluded from any clinical trials that I can find, unless you are BRAF positive (a kind of mutation, which Meagan doesn't have). So the hope is that your brain is at least free of disease for long enough after a particular brain tumor treatment that you can slide into a clinical trial. When you have brain tumors though, most trials have some sort of exclusion, like being free of brain disease for three months, not having any body tumors (hah!), having had prior chemo, etc. 
I have spent the day re-researching all the clinical trials underway on melanoma, through the clinicaltrials.gov website. All the ones that would be relevant have exclusionary criteria for active brain metastases. So if any tumor activity shows up in the scans in July it is pretty much moot - our only recourse will be using established drugs like Interleukin or some sort of chemotherapy (along with radiation treatment of any new brain tumors). Unfortunately those have very low response rates. 
If there is no brain cancer activity, the question is can I find a research institute connected with a hospital and a melanoma specialist that doesn't have the same exclusions as does the NCI. I sent off three emails today to the top melanoma specialists in the country seeking their advice and requesting participation criteria for the trails they are running (which are similar to the NCI trials).

In inquiring on the melanoma forum I frequent, I have learned a lot over the last three months about melanoma and brain tumors. When it goes to the brain it's just not good at all. The brain and body have a natural separation (the blood brain barrier) that makes treatment problematic. So it's almost like you are treating two separate diseases. Even if the chemo worked on the body tumors, it won't work on the brain. There are no treatments which have proven effective yet for melanoma which has migrated to the brain. It really is about control, controlling the tumors as long as you can until a treatment is developed. 

It's really unfortunate  news about the NCI - because at least there was some hope there for treatment of the melanoma in the body. Meagan and I were understandably upset today.

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