I am not saying this will apply to anyone or everyone, but I think it is important that everyone needs to read this.
From MIF: Anyone currently on clincial trial of PLX 4032 or RO5185426 (jenniferslatton)
Posted: 3:20:38 pm on 1/27/2010 Modified: 4:12:04 pm on 1/27/2010
My 39-year-old husband is (as far as I know) the first U.S. patient to be in the Phase II BRAF-inhibitor trial funded by Roche Labs (partnering with Plexxikon). This trial uses the drug alone, without an arm that might include chemotherapy drugs (like the Phase III). He is on 960 mg twice aday of the drug, the highest tolerated dose. We are being treated at Moffitt in Tampa.
Clint began the trial the first week of October, about 15 weeks ago. We were astounded with the positive results and almost non-existent side effects (loss of body hair and mild muscle fatigue). That is, until last week, when the drug (PLX 4032/RO5185426) seems to have abruptly stopped working.
After much research we are learning that this is perhaps not an unexpected response. From my most recent reading it seems that for patients who are positive for the BRAF mutation (70% of melanoma patients), the BRAF-inhibitor may be necessary but not sufficient to create long-term effects. In my husband's case, we had genetic testing that determined the only mutation of note that could cause melanoma is the BRAF V600E mutation. But once he began the BRAF-inhibitor, the cancer seems to have created a new pathway around the drug. We will know shortly whether my husband's body has created new mutations and if so, which ones.
We are therefore, scrambling to find a new study that uses a combinatorial therapy of BRAF-inhibitor and MEK/RAS inhibitor (depending on what, if any, new mutations Clint has). I believe this combo therapy is likely to be the new frontier, and is already being studied in many places, including Australia and England. There is a combinatorial trial preparing to open in Nashville, TN, and I've got a call into their office to find out when. Now that the BRAF-inhibitor seems to have stopped working for my husband, we are in a race against the clock to once again stop his extremely aggressive, fast-moving disease.
In no way do I wish to "pull the rug out from under" any of you who are fortunate enough to be a patient on a BRAF-inhibitor trial. It has been an amazing drug! But I want to make sure we get our experience out there because we were very frustrated to not be given full disclosure about the likelihood of the disease finding new pathways. We had specifically asked our oncologist about a Plan B if the drug stopped working and he was dismissive of our question.
Now that we are in this scary place of seeing the disease quickly progress again, we have learned that the melanoma is now in his brain. This precludes Clint from most other clinical trials. If we had not let our guard down and had been looking ahead to combinatorial therapies, it would have made a big difference.
http://forum.melanomaintl.org/toastforums/toast.asp?sub=show&action=posts&fid=4&tid=9190
This is an indication that over time, Melanoma can mutate and change pathways to escape the immune system. As doctor's search for a cure, the BRAF therapy may end up as a "bridge therapy". Bascially something to fill in why they continue to look for more treatments.
I myself believe that the best way to overcome Melanoma is to use your own immune system.It can be done using a combination approach. Interferon,DTIC,Patrin-2,radiation,Anti-CTLA-4 and Interluekin-2. It is like a bicyle lock, you have to know the combination and proceed in the right order. The number of turns to the right or left corresponds to the doses and concentration.
Here is the combination, Good Luck!!!!!
Take Care,
Jimmy B
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