GSK DERMA (MAGE A3) clinical trial ???

Hi Carole,

I do get several side effects.  I get swelling, redness and tenderness at the injection site.  I also have "flu-like" symptoms for a couple of days, along with some fatigue.  I usually have body aches, joint pain, sweats and just feel lousy.  It starts about 10-12 hours after my injection and the worst is over within 48 hours.  Based on the literature I have read, I assume I am getting the vaccine and not the placebo………but I do not know that for sure.  Maybe just wishful thinking on my part!  I am now 8 months out from my diagnosis and praying I stay NED.

I had one positive node, so I am 3B.  My Dr did not think radiation was needed.  My only options were 1)watch and wait  2)interferon  3)DERMA trial since I qualified.  I was not OK with doing nothing and I really did not like the statisitcs for interferon……..so I decided to take the chance with the clinical trial. 

Make your decision based on the best info for your case and try not to second guess yourself later.  It is difficult when there is no "right" answer.  Let me know what you decide and feel free to contact me any time.

Michelle/3B

Hi Michelle,

     I just had my first shot and I think I must be on the placebo. Absolutely no side effects. Not even a tender IJ site. Darn  darn darn! Is there anyone else out there on this trial?????

Carole

Hey Carole,

After my first injection all I had was MILD tenderness at injection site.  The first night I woke up around 2am and thought I did not feel well…..but I thought it could be my "wishful thinking" it was a side effect.  It was not until the 2nd injection that I knew I was having side effects.  I was told that some people peak with symptoms after 3rd or 4th injection with vaccines.  Mine did get a little worse each time and leveled off around the 4th one.  Wait until next injection to see what happens!!  I have to say, it was the first time I ever wished for the side effects!!

Keep a positive outlook……I know it is hard sometimes!

Keep me posted,

Michelle

Thank you , thank you, thank you, Michelle. I will keep my hopes up for the next few rounds.

Carole

Thank you , thank you, thank you, Michelle. I will keep my hopes up for the next few rounds.

Carole

Hey Carole,

After my first injection all I had was MILD tenderness at injection site.  The first night I woke up around 2am and thought I did not feel well…..but I thought it could be my "wishful thinking" it was a side effect.  It was not until the 2nd injection that I knew I was having side effects.  I was told that some people peak with symptoms after 3rd or 4th injection with vaccines.  Mine did get a little worse each time and leveled off around the 4th one.  Wait until next injection to see what happens!!  I have to say, it was the first time I ever wished for the side effects!!

Keep a positive outlook……I know it is hard sometimes!

Keep me posted,

Michelle

Hi Michelle,

     I just had my first shot and I think I must be on the placebo. Absolutely no side effects. Not even a tender IJ site. Darn  darn darn! Is there anyone else out there on this trial?????

Carole

Hi Carole,

I do get several side effects.  I get swelling, redness and tenderness at the injection site.  I also have "flu-like" symptoms for a couple of days, along with some fatigue.  I usually have body aches, joint pain, sweats and just feel lousy.  It starts about 10-12 hours after my injection and the worst is over within 48 hours.  Based on the literature I have read, I assume I am getting the vaccine and not the placebo………but I do not know that for sure.  Maybe just wishful thinking on my part!  I am now 8 months out from my diagnosis and praying I stay NED.

I had one positive node, so I am 3B.  My Dr did not think radiation was needed.  My only options were 1)watch and wait  2)interferon  3)DERMA trial since I qualified.  I was not OK with doing nothing and I really did not like the statisitcs for interferon……..so I decided to take the chance with the clinical trial. 

Make your decision based on the best info for your case and try not to second guess yourself later.  It is difficult when there is no "right" answer.  Let me know what you decide and feel free to contact me any time.

Michelle/3B

Just had my 3rd injection yesterday. Not sure if I had any side effects because what I experienced yesterday was different that what I experienced earlier. Didn't have the hot flashes that I experienced after the first two shots, but I did feel like I was run over by a truck after I got home. I was tired, had chills, felt queasy, had no appetite, had a headache, and a stiff achy back. Also experienced a few heart minor heart palpitations. I was so tired that I just headed to bead between 9:30-10:00 and didn't open my eyes until the alarm went off in the morning. I felt fine when I got up this morning.

About all I can hope is pray that I have the same reaction after shot #4.

Just had my 3rd injection yesterday. Not sure if I had any side effects because what I experienced yesterday was different that what I experienced earlier. Didn't have the hot flashes that I experienced after the first two shots, but I did feel like I was run over by a truck after I got home. I was tired, had chills, felt queasy, had no appetite, had a headache, and a stiff achy back. Also experienced a few heart minor heart palpitations. I was so tired that I just headed to bead between 9:30-10:00 and didn't open my eyes until the alarm went off in the morning. I felt fine when I got up this morning.

About all I can hope is pray that I have the same reaction after shot #4.

OOPS! I was given the same treatment options that Michelle's doctor gave her.

My next treatment (shot) is April 13. I'll let you all know how it goes.

It sure is great to be in contact with someone else in the trial!

Carole

Carole,

How did your shot go?

Linda

Hi Linda,

     How are you doing?

     I've had 2 shots now. No side effects locally at the injection site, and the only possible side effect that I can think is fatigue. I am really tired, spend most evenings on the couch, not like me at all.  Do anything physical and find I have to have a rest.

Nothing else to report. Although I am praying that I am on the drug, I am certainly not counting on it.

watchful waiting with a few shots now and again is where I'm at.

How about the others on this trial????? How are you all doing????? Any new symptoms?????

Keep healthy, Everyone,

Carole

Hi Linda,

     How are you doing?

     I've had 2 shots now. No side effects locally at the injection site, and the only possible side effect that I can think is fatigue. I am really tired, spend most evenings on the couch, not like me at all.  Do anything physical and find I have to have a rest.

Nothing else to report. Although I am praying that I am on the drug, I am certainly not counting on it.

watchful waiting with a few shots now and again is where I'm at.

How about the others on this trial????? How are you all doing????? Any new symptoms?????

Keep healthy, Everyone,

Carole

I've had two shots as well. Can't say with 100% certainty whether I've had a reaction yet or not. A few hours after my first shot I had an intense hot flash — more intense than any hormonal hot flash I've had.  This was followed by feeling really cold shortly afteward. i didn't know what to make of it, Had a similar experience after my second shot during the drive home from the hospital, which was repeated after we arrived home but with a headache to boot.

Now, the hospital where I'm going for treatments is a 2 hour drive each way so I'm not sure if my body's reacting to the long day or to the vaccine. The nurse at the hospital did say that other patients have reported "hot flashes" like mine.

Shot #3 will come on May 10, so we'll see what happens this time.

But regardless, I'm glad to have the close observation along wtih a 2 out of 3 chance of receiving the vaccine. So for me, this is win-win.

Hi Linny,

     My next shot is on May 4th. I "ll let you know how I go on. I really appreciate knowing  about your experience with this trial. What a journey we are all sharing!

Keep well,

Carole

Hi Linny,

     My next shot is on May 4th. I "ll let you know how I go on. I really appreciate knowing  about your experience with this trial. What a journey we are all sharing!

Keep well,

Carole

Just read on a different post that you had your lymphadenectomy done in January. So did I! Mine was done January 27.

It's some journey, isn't it?

Hi Linny,

Sure is!!!!!

I had mine done on Jan 24th. Isn't it amazing how all these dates stay with us?? Do keep in touch.

Carole

Just had my 3rd injection as part of this DERMA trial. It really hurt while being injected, but within an few hours I couldn't even find the injection site. Some fatigue, but nil else. Life is going on. This trial is really very easy to be involved with….now if only the drug works!!!

Carole

Hi

Four days after the IJ , I felt really lethargic.  Couldn't keep my eyes open. Had a nap and then went to bed early. Better the next day and now fell only slightly tired all the time.

How is everyone lese doing on this trial????

Carole

Hi,

     Just had the 3 month CT scan. Feel fine. Sure do hate the waiting for results! We live in Manitoba on the lake which is flooding badly. Spent many hours sand-bagging …and am relived to say that I am having no trouble with my arm  (node removal in Jan) except a little local numbness.

     How is everyone else doing on the trial????

Carole   back 3C

I will have my 8th injection on July 11.  So far, I am still NED.  I will have CTs the first week of July before my appt………so hopefully, I can still report NED after that!  I still have about the same symptoms after each injection….sweats,chills, "flu-like" body aches, fatique,etc.  My 1 year anniversay  of my diagnosis is next week.  So at least I have made it to see the first one, and I plan on celebrating many more! 

Michelle/3B

I will have my 8th injection on July 11.  So far, I am still NED.  I will have CTs the first week of July before my appt………so hopefully, I can still report NED after that!  I still have about the same symptoms after each injection….sweats,chills, "flu-like" body aches, fatique,etc.  My 1 year anniversay  of my diagnosis is next week.  So at least I have made it to see the first one, and I plan on celebrating many more! 

Michelle/3B

Hi,

     Just had the 3 month CT scan. Feel fine. Sure do hate the waiting for results! We live in Manitoba on the lake which is flooding badly. Spent many hours sand-bagging …and am relived to say that I am having no trouble with my arm  (node removal in Jan) except a little local numbness.

     How is everyone else doing on the trial????

Carole   back 3C

Hi

Four days after the IJ , I felt really lethargic.  Couldn't keep my eyes open. Had a nap and then went to bed early. Better the next day and now fell only slightly tired all the time.

How is everyone lese doing on this trial????

Carole

Just had my 3rd injection as part of this DERMA trial. It really hurt while being injected, but within an few hours I couldn't even find the injection site. Some fatigue, but nil else. Life is going on. This trial is really very easy to be involved with….now if only the drug works!!!

Carole

Hi Linny,

Sure is!!!!!

I had mine done on Jan 24th. Isn't it amazing how all these dates stay with us?? Do keep in touch.

Carole

Just read on a different post that you had your lymphadenectomy done in January. So did I! Mine was done January 27.

It's some journey, isn't it?

I've had two shots as well. Can't say with 100% certainty whether I've had a reaction yet or not. A few hours after my first shot I had an intense hot flash — more intense than any hormonal hot flash I've had.  This was followed by feeling really cold shortly afteward. i didn't know what to make of it, Had a similar experience after my second shot during the drive home from the hospital, which was repeated after we arrived home but with a headache to boot.

Now, the hospital where I'm going for treatments is a 2 hour drive each way so I'm not sure if my body's reacting to the long day or to the vaccine. The nurse at the hospital did say that other patients have reported "hot flashes" like mine.

Shot #3 will come on May 10, so we'll see what happens this time.

But regardless, I'm glad to have the close observation along wtih a 2 out of 3 chance of receiving the vaccine. So for me, this is win-win.

Carole,

How did your shot go?

Linda

My next treatment (shot) is April 13. I'll let you all know how it goes.

It sure is great to be in contact with someone else in the trial!

Carole

OOPS! I was given the same treatment options that Michelle's doctor gave her.

Hi Everyone,

I started the DERMA trial in Feb of this year. Unfortunately have developed bone mets in my right knee so will be out of the trial. I see the radiation oncologist to get some pain control tomorrow. Ibelieve that I was on the placebo arm as I had no local reaction to the injections.

     So am now a new Stage 4! Hope to get on Ipi after all scans have been done.

Good luck to the rest of you. I will be watching how you all get on.

Carole

I am so sorry to hear about your recent progression.  Keep us posted and I pray the radiation and ipi will take care of all this for you. 

Michelle/3B

I am so sorry to hear about your recent progression.  Keep us posted and I pray the radiation and ipi will take care of all this for you. 

Michelle/3B

I am sorry to hear that you're a member of the Stage IV club now. Thank goodness that IPi and Zelboraf are now available as treatments. At least your options are better than they were a year ago.

I'm not sure you'll ever know if you received the placebo or the MAGE vaccine.

Am sending prayers and healing thoughts your way.

Linda

I am sorry to hear that you're a member of the Stage IV club now. Thank goodness that IPi and Zelboraf are now available as treatments. At least your options are better than they were a year ago.

I'm not sure you'll ever know if you received the placebo or the MAGE vaccine.

Am sending prayers and healing thoughts your way.

Linda

Hi Everyone,

I started the DERMA trial in Feb of this year. Unfortunately have developed bone mets in my right knee so will be out of the trial. I see the radiation oncologist to get some pain control tomorrow. Ibelieve that I was on the placebo arm as I had no local reaction to the injections.

     So am now a new Stage 4! Hope to get on Ipi after all scans have been done.

Good luck to the rest of you. I will be watching how you all get on.

Carole