PLEASE need BRAF or IPI Experiences (the good,bad, ugly)!

Wendy,

You've said that you've just had surgeries so far. In that case you are not eligible for the ipi compassionate care. You've had to have something systemic and failed.  I'm not sure about the B-raf drugs.

I'm in the same decision mode but have to wait 3 months till my next scans to see if lung nodule grows.  Personally in my thoughts right now, I'm planing on holding off with the B-raf till they have some combo's out there. Also want to see if maybe I can have a complete response using something else that will last longer. 

Best wishes,

Linda

Stage IV since 06

Wendy,

You've said that you've just had surgeries so far. In that case you are not eligible for the ipi compassionate care. You've had to have something systemic and failed.  I'm not sure about the B-raf drugs.

I'm in the same decision mode but have to wait 3 months till my next scans to see if lung nodule grows.  Personally in my thoughts right now, I'm planing on holding off with the B-raf till they have some combo's out there. Also want to see if maybe I can have a complete response using something else that will last longer. 

Best wishes,

Linda

Stage IV since 06

The choice to me is clear:  I would pick ipi because you have a chance for a durable response which is very rare for BRAF.  You might also search for Anti PD-1 trials.  It is similar to ipi but has fewer side effects.  Initial results are very promising.

I was on the compassionate use trial, and was a responder.  Actually an over-responder.  I developed colitis and had to go on high-dose steroids which negated much of the ipi benefit.  Because I did have some response, I would have qualified for a second round of ipi, but given the colitis that will not happen.  By the way, the colitis is gone now.

I don't think you have to worry about what happened to me.  It is very rare at the compassionate use dosage of 3mg.  If I had to do it over again, the only thing I would do differently is I would have looked for anti PD-1 trials before I went on the ipi.  Right now, ipi users are disqualified from anti PD-1 trials.  Perhaps that will change when ipi is approved, but that is only a guess on my part.

I don't regret going on the ipi trial even though the colitis was no fun!  I am BRAF negative, so I don't have the choice you face.  However, I am looking into trials that can lead to a durable response first.  My next step is adoptive cell transfer therapy (ACT), which is rougher than getting colitis I hear.  However, there is a chance of a durable response, so I'm game.

Good luck with your decision!

The choice to me is clear:  I would pick ipi because you have a chance for a durable response which is very rare for BRAF.  You might also search for Anti PD-1 trials.  It is similar to ipi but has fewer side effects.  Initial results are very promising.

I was on the compassionate use trial, and was a responder.  Actually an over-responder.  I developed colitis and had to go on high-dose steroids which negated much of the ipi benefit.  Because I did have some response, I would have qualified for a second round of ipi, but given the colitis that will not happen.  By the way, the colitis is gone now.

I don't think you have to worry about what happened to me.  It is very rare at the compassionate use dosage of 3mg.  If I had to do it over again, the only thing I would do differently is I would have looked for anti PD-1 trials before I went on the ipi.  Right now, ipi users are disqualified from anti PD-1 trials.  Perhaps that will change when ipi is approved, but that is only a guess on my part.

I don't regret going on the ipi trial even though the colitis was no fun!  I am BRAF negative, so I don't have the choice you face.  However, I am looking into trials that can lead to a durable response first.  My next step is adoptive cell transfer therapy (ACT), which is rougher than getting colitis I hear.  However, there is a chance of a durable response, so I'm game.

Good luck with your decision!

Hi Wendy,

I am a participant of a double blind trial with 10 mg/kg of ipi. I've been on that trial since September 2009 and have had 8 rounds of ipi during that time. Although I am thinking about ending the trial at the moment, I do not regret participating this trial.

I to had a colitis, for me it was after the 4th infusion (that is an obvious sign that I do get the medicine and not the placebo). I had a terrible night in the bathroom with that, but it ended immediately after I started prednison.

For the rest I had different versions of rash, itching, headaches and fatigue.

The reason I want to end the trial now, is that I am exhausted since my last infusion (4 weeks ago). It's getting me depressed, which is not what I want. As I did not have an active tumor, I will never know if ipi did it's work, but I imagine that the 8 rounds should be enough (especially since people seem to do great on 4 rounds of only 3 mg/kg).

I did not look into the Braf trials, and I can not say anything about that. 

Good luck with your decision,

Sabine

Hi Wendy,

I am a participant of a double blind trial with 10 mg/kg of ipi. I've been on that trial since September 2009 and have had 8 rounds of ipi during that time. Although I am thinking about ending the trial at the moment, I do not regret participating this trial.

I to had a colitis, for me it was after the 4th infusion (that is an obvious sign that I do get the medicine and not the placebo). I had a terrible night in the bathroom with that, but it ended immediately after I started prednison.

For the rest I had different versions of rash, itching, headaches and fatigue.

The reason I want to end the trial now, is that I am exhausted since my last infusion (4 weeks ago). It's getting me depressed, which is not what I want. As I did not have an active tumor, I will never know if ipi did it's work, but I imagine that the 8 rounds should be enough (especially since people seem to do great on 4 rounds of only 3 mg/kg).

I did not look into the Braf trials, and I can not say anything about that. 

Good luck with your decision,

Sabine

I guess it's kind of corny to ask…but did they test you for the B-raf mutation yet? Ipi will more than likely be approved in March so they criteria for systemic treatment will probably not be an issue.

You should also get your HLA testing done as well as for the various mutations…those things weigh heavy on which trial you can actually get into…

I had none of those tests when I first started looking into trials…wasted a lot of time getting them…be sure to get them soon! Be armed and ready!

I guess it's kind of corny to ask…but did they test you for the B-raf mutation yet? Ipi will more than likely be approved in March so they criteria for systemic treatment will probably not be an issue.

You should also get your HLA testing done as well as for the various mutations…those things weigh heavy on which trial you can actually get into…

I had none of those tests when I first started looking into trials…wasted a lot of time getting them…be sure to get them soon! Be armed and ready!

Hi Wendy, I tested negative for BRAF so ipi was my oncologist''s next choice of drug.  I actually wanted to do 'ipi' so it all worked out.  In August, my tumors were rampant and I believe if I had not been able to get on to the trial in September, I would be in terrible shape right now.  I have had very little side effects…fatigue a little (but doesn't hold me back), a bit more gaseous than before but really nothing to fear!!!  I have done 4 rounds so now I am waiting for CT scan results..and praying it's working.  Visually, my cutaneous tumors seem to have come to a halt as far as spreading and some are actually drying up as well the bluish tinge in my leg seems to not be as bad…so hopefully, I will have good results.  I have noticed a slight growth on the left groin area and I will be contacting my oncologist on Tuesday when she is in….but my clinical nurse is thinking that is something that appears to be common..maybe lymph node reaction.

All in all..this is SO MUCH BETTER than interferon to date…Val  (compassionate ipi trial)

Hi Wendy, I tested negative for BRAF so ipi was my oncologist''s next choice of drug.  I actually wanted to do 'ipi' so it all worked out.  In August, my tumors were rampant and I believe if I had not been able to get on to the trial in September, I would be in terrible shape right now.  I have had very little side effects…fatigue a little (but doesn't hold me back), a bit more gaseous than before but really nothing to fear!!!  I have done 4 rounds so now I am waiting for CT scan results..and praying it's working.  Visually, my cutaneous tumors seem to have come to a halt as far as spreading and some are actually drying up as well the bluish tinge in my leg seems to not be as bad…so hopefully, I will have good results.  I have noticed a slight growth on the left groin area and I will be contacting my oncologist on Tuesday when she is in….but my clinical nurse is thinking that is something that appears to be common..maybe lymph node reaction.

All in all..this is SO MUCH BETTER than interferon to date…Val  (compassionate ipi trial)

Hi Wendy,

Treatment decisions are so hard to make, aren't they? I'm B-RAF negative, so that was never an option for me, but I am now on the Ipi Compassionate use trial. I just finished the first induction phase (12 weeks, ipi every 3 weeks), and am just starting the maintenance phase (nothing for 12 weeks, then a scan). Unlike a lot of other people, I have had no side effects like those I was warned about. I did have one bout of diarrhea, but I think that was more due to what I had eaten, not the ipi. I've had no rash or itchiness or anything else.

To make things more complicated, I'm going to throw another option into the mix. It's PV-10 intraleasional injections. I noticed you said your mel was only in your leg, so I would assume that all your lesions are either cutaneous or sub-cutaneous. I did this treatment when it was in a phase 2 trial. It is now available in a compassionate use trial. The clinical trial page says it's not recruiting yet, but I do know for a fact that St Luke's in Bethlehem, PA is now accepting participants, so maybe some of the others have started too. The link is below. I responded really well to this treatment, but we didn't realize when I started that the mel had already gone to my uterus, so once it was picked up, I had to withdraw from the study. This treatment involves injecting the tumors with rose bengal (PV-10). It stings like the devil for a minute, but then it's gone. The main side effect is photosensitivity. Most of the tumours in my leg that were injected, disappeared within a few weeks. So check this out. Ipi will still be there later if you need it. It may even be an approved treatment by then.

Hope this helps

Hugs

Sharyn, Stage IV

http://clinicaltrials.gov/ct2/show/NCT00521053?term=PV-10+and+melanoma&rank=1 

Hi Wendy,

Treatment decisions are so hard to make, aren't they? I'm B-RAF negative, so that was never an option for me, but I am now on the Ipi Compassionate use trial. I just finished the first induction phase (12 weeks, ipi every 3 weeks), and am just starting the maintenance phase (nothing for 12 weeks, then a scan). Unlike a lot of other people, I have had no side effects like those I was warned about. I did have one bout of diarrhea, but I think that was more due to what I had eaten, not the ipi. I've had no rash or itchiness or anything else.

To make things more complicated, I'm going to throw another option into the mix. It's PV-10 intraleasional injections. I noticed you said your mel was only in your leg, so I would assume that all your lesions are either cutaneous or sub-cutaneous. I did this treatment when it was in a phase 2 trial. It is now available in a compassionate use trial. The clinical trial page says it's not recruiting yet, but I do know for a fact that St Luke's in Bethlehem, PA is now accepting participants, so maybe some of the others have started too. The link is below. I responded really well to this treatment, but we didn't realize when I started that the mel had already gone to my uterus, so once it was picked up, I had to withdraw from the study. This treatment involves injecting the tumors with rose bengal (PV-10). It stings like the devil for a minute, but then it's gone. The main side effect is photosensitivity. Most of the tumours in my leg that were injected, disappeared within a few weeks. So check this out. Ipi will still be there later if you need it. It may even be an approved treatment by then.

Hope this helps

Hugs

Sharyn, Stage IV

http://clinicaltrials.gov/ct2/show/NCT00521053?term=PV-10+and+melanoma&rank=1 

Hi Wendy,

 I had 4 doses of Ipi at 10mg/kg. I had no tumor as I went into the trial with resected melanoma. Mostly my side effects were mild except for the severe headaches I had for 2 weeks. An MRI revealed I had hypophysitis (swelling of the pituitary gland). My pituitary gland regained it's normal size but it's function hasn't come back. For over 2 years I've been on a steroid as a hormone replacement. Hypophysitis, colitis, or a severe rash are conditions called immune breakthrough events and correlate with best outcomes (less chance of a recurrence). My oncologist said my immune response was at least 5 times over baseline and he sees that response in 10-20% of patients. How he came to that conclusion was through doing immune assays from apherisis.

 I had apheresis (also called leukaphereisis) done 3 times. First they access a vein in each arm to put in an iv ( in one hospital I understand they access 1 vein in the neck). The veins are flushed to make sure there is a free flow. While I'm lying on my back on a cot these ivs are hooked up to a cell separator machine. When this is in place for the next 3 hours I'd be lying on my back while blood leaves me through the right vein. The blood then goes through the cell separator machine where the blood is divided into white blood cells, red blood cells and plasma. Slowly these three are collected in bags. The whole while the rest of my blood comes back to me through the iv on my left arm. The oncologist is most interested in the white blood cells and conducts immune assays (some kind of research). The first aphereisis was to do a baseline of the immune system, and I think to determine the level of dendritic cells. The second apheresis is to do a comparison. That's when my doctor saw the big immune response (and many more dentritic cells). The third apheresis was done to determine if I had a sustained response. It showed I did. That is basically the process.

 Hope this helps and God Bless,

 Jim M.

 stage 3C

Hi Wendy,

 I had 4 doses of Ipi at 10mg/kg. I had no tumor as I went into the trial with resected melanoma. Mostly my side effects were mild except for the severe headaches I had for 2 weeks. An MRI revealed I had hypophysitis (swelling of the pituitary gland). My pituitary gland regained it's normal size but it's function hasn't come back. For over 2 years I've been on a steroid as a hormone replacement. Hypophysitis, colitis, or a severe rash are conditions called immune breakthrough events and correlate with best outcomes (less chance of a recurrence). My oncologist said my immune response was at least 5 times over baseline and he sees that response in 10-20% of patients. How he came to that conclusion was through doing immune assays from apherisis.

 I had apheresis (also called leukaphereisis) done 3 times. First they access a vein in each arm to put in an iv ( in one hospital I understand they access 1 vein in the neck). The veins are flushed to make sure there is a free flow. While I'm lying on my back on a cot these ivs are hooked up to a cell separator machine. When this is in place for the next 3 hours I'd be lying on my back while blood leaves me through the right vein. The blood then goes through the cell separator machine where the blood is divided into white blood cells, red blood cells and plasma. Slowly these three are collected in bags. The whole while the rest of my blood comes back to me through the iv on my left arm. The oncologist is most interested in the white blood cells and conducts immune assays (some kind of research). The first aphereisis was to do a baseline of the immune system, and I think to determine the level of dendritic cells. The second apheresis is to do a comparison. That's when my doctor saw the big immune response (and many more dentritic cells). The third apheresis was done to determine if I had a sustained response. It showed I did. That is basically the process.

 Hope this helps and God Bless,

 Jim M.

 stage 3C

Basically they stick a needle in one arm which the blood goes out into a line and into a machine that separates the T cells from the rest of the blood and the remainning blood goes back into the body…it's not like a lot of blood is out of your body at any given time in the process…it's painless except for the needle pricks…

Basically they stick a needle in one arm which the blood goes out into a line and into a machine that separates the T cells from the rest of the blood and the remainning blood goes back into the body…it's not like a lot of blood is out of your body at any given time in the process…it's painless except for the needle pricks…