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Experimental vaccines: Any thoughts/advice?

Forums General Melanoma Community Experimental vaccines: Any thoughts/advice?

  • Post
    ET-SF
    Participant

      ET seems to be (haven't yet confirmed the exact appointment) lined up with the melanoma center at Inova Fairfax.  They are participating in a Phase III trial of seviprotimut-L (POL-103a) at that center, and ET would qualify for the study, being NED, surgically resected stage IIb.  ET also qualifies for a couple of other vaccine trials.  There are no other trials at this time for which she qualifies, given her stage.  We are trying to figure out which vaccine trial would be most promising for her to undergo.

      Option 1:  Phase III seviprotimut-L trial at Inova (NCT01546571):  This vaccine, manufactured by Hong Kong-based Polynoma, was first developed in the mid 80's and has a very small body of research behind it throughout the years.  From what I'm reading, it seems to be somewhat successful at mopping up free melanoma cells in the circulatory system and especially reducing serum CYT-MAA (cytoplasmic melanoma-associated antigen).  Perhaps the CYT-MAA effect is from a reduction of tumor load and therefore shed antigens?  Although the vaccine doesn't work on everyone, it works on some, somewhat extending the duration of recurrence-free survival.  The problem with this Phase III study is that the experimental design uses a placebo control group.  I don't yet know whether they use unequal sample sizes for the experimental vs. control groups.  (Some studies will greatly diminish the size of the control group for ethical/compassionate reasons.)

      Option 2: Phase I trial of GVAX, Lipson, Johns Hopkins (NCT01435499):  Compares GVAX of two strains, combining one strain with cyclophosphamide.  GVAX vaccine, developed 1993, manufactured by BioSante Pharmaceuticals, consists of whole tumor cells that have been genetically modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor).  These whole cells are first irradiated to prevent cell division.  If I understand correctly, the strategy is to use the GM-CSF to stimulate macrophages to engulf them, digest them, and express their component antigens.  I am finding no data so far as to any measure of efficacy, other than immunological findings.  But then again, I suppose that's why it's still in Phase I testing.  Lipson is trying to determine how well the drug is tolerated

      Option 3: Phase II trial of CDX-1401 and poly-ICLC, with or without CDX-301, Hanks, Duke (NCT02129075).  I don't know whether this trial is still in progress, as I don't see it listed on the Duke website.  These vaccines are manufactured by Celldex.  CDX-1401 is a MAB specific to the DEC-205 antigen on dendritic cells, activating these cells against the NY-ESO-1 tumor antigen.  (I have no idea whether ET's tumor expresses this antigen.  Could this be tested?)  CDX-301 stimulates production of dendritic cells.  Poly-ICLC (mfgr, Oncovir) is a viral mimic that acts as an immunostimulant.

      Any thoughts as to which of these three choices might hold the most promise for ET at her stage IIb?  Note: We have no insurance coverage that would help us with options 2 or 3.  I don't know what sorts of costs would not be covered by the research grant.  Only option 1 is conducted by physicians and a melanoma center covered under our insurance.

      Thanks for any thoughts on these vaccine trials!  We continue to be hard at work learning all this stuff!  There's sooooo much to learn!

      SF

    Viewing 11 reply threads
    • Replies
        ET-SF
        Participant

          PS I'm not sure why this posted anonymously, but we're ET-SF (only being semianonymous). cool

          ET-SF
          Participant

            PS I'm not sure why this posted anonymously, but we're ET-SF (only being semianonymous). cool

            ET-SF
            Participant

              PS I'm not sure why this posted anonymously, but we're ET-SF (only being semianonymous). cool

              ed williams
              Participant

                Hi ET-SF, I thought you might like to get some up to date findings on Vaccines from one of the experts in the Melanoma field. Dr. Jeffrey S Webber of Moffit Cancer Center speaks on a webinar from 'Cancer Research Institute." How to find the webinar is easy, after you find the Cancer Research Institute home page go over to right side of page and click on "News and Publications" , then pick webinars and you will get serval to choose from. Dr. Weber speaks about Vaccines at the 46.30 min mark of the webinar titled "Cancer Revealed How our Immune systems sees and destroys tumors." Hope this will help in making your decision. Wishing you the best!!! Ed

                  ET-SF
                  Participant

                    Thanks!  πŸ™‚

                    katie1
                    Participant

                      I think I remember you writing that there were microsatelitosis mentioned in ET's initial pathology. I would suggest querying that as it may change the staging and also what trials are available (a similar thing happened with my husband) 

                      Kate

                      ET-SF
                      Participant

                        Thanks!  We hadn't thought of that.  That's definitely worth exploring, as it would open up more treatment/trial possibilities.  In point of fact, the only person who has staged ET is myself.  I did ask the surgeon whether we were dealing with stage IIb, and she nodded "yes,"  But it's not down on paper anywhere and not official.

                        ET-SF
                        Participant

                          Thanks!  We hadn't thought of that.  That's definitely worth exploring, as it would open up more treatment/trial possibilities.  In point of fact, the only person who has staged ET is myself.  I did ask the surgeon whether we were dealing with stage IIb, and she nodded "yes,"  But it's not down on paper anywhere and not official.

                          ET-SF
                          Participant

                            Thanks!  We hadn't thought of that.  That's definitely worth exploring, as it would open up more treatment/trial possibilities.  In point of fact, the only person who has staged ET is myself.  I did ask the surgeon whether we were dealing with stage IIb, and she nodded "yes,"  But it's not down on paper anywhere and not official.

                            katie1
                            Participant

                              I think I remember you writing that there were microsatelitosis mentioned in ET's initial pathology. I would suggest querying that as it may change the staging and also what trials are available (a similar thing happened with my husband) 

                              Kate

                              katie1
                              Participant

                                I think I remember you writing that there were microsatelitosis mentioned in ET's initial pathology. I would suggest querying that as it may change the staging and also what trials are available (a similar thing happened with my husband) 

                                Kate

                                ET-SF
                                Participant

                                  Thanks!  πŸ™‚

                                  ET-SF
                                  Participant

                                    Thanks!  πŸ™‚

                                    ET-SF
                                    Participant

                                      Very interesting webinar.  I've now watched it twice, and ET watched it once.  And we see several other webinars we want to watch, once our brains have recovered a bit and are ready to be filled with more information.

                                      I thought Dr. Weber's comments regarding vaccine therapy were interesting.  His thinking is perhaps not too distant from my own thinking — that while vaccine therapy might not be particularly promising as a monotherapy, it might still help to entrain the immune system to pertinent neoantigens, so that if/when immunotherapy is needed, the immune system will be better entrained to its target.

                                      So there may not be glowing success with this vaccine, but doing something is surely better than doing nothing.  There might be some small benefit.

                                      I think ET and I are too old for Halloween, but I'm thinking I could wear a lab coat and clip board, and she could dress as a guinea pig.  ;->

                                      ET-SF
                                      Participant

                                        Very interesting webinar.  I've now watched it twice, and ET watched it once.  And we see several other webinars we want to watch, once our brains have recovered a bit and are ready to be filled with more information.

                                        I thought Dr. Weber's comments regarding vaccine therapy were interesting.  His thinking is perhaps not too distant from my own thinking — that while vaccine therapy might not be particularly promising as a monotherapy, it might still help to entrain the immune system to pertinent neoantigens, so that if/when immunotherapy is needed, the immune system will be better entrained to its target.

                                        So there may not be glowing success with this vaccine, but doing something is surely better than doing nothing.  There might be some small benefit.

                                        I think ET and I are too old for Halloween, but I'm thinking I could wear a lab coat and clip board, and she could dress as a guinea pig.  ;->

                                        ET-SF
                                        Participant

                                          Very interesting webinar.  I've now watched it twice, and ET watched it once.  And we see several other webinars we want to watch, once our brains have recovered a bit and are ready to be filled with more information.

                                          I thought Dr. Weber's comments regarding vaccine therapy were interesting.  His thinking is perhaps not too distant from my own thinking — that while vaccine therapy might not be particularly promising as a monotherapy, it might still help to entrain the immune system to pertinent neoantigens, so that if/when immunotherapy is needed, the immune system will be better entrained to its target.

                                          So there may not be glowing success with this vaccine, but doing something is surely better than doing nothing.  There might be some small benefit.

                                          I think ET and I are too old for Halloween, but I'm thinking I could wear a lab coat and clip board, and she could dress as a guinea pig.  ;->

                                          ed williams
                                          Participant

                                            It is pretty deep material, that is why I was dirrecting you to the question and answer section. If you want another idea in the same group of webinars, there is one from Dr. Ribas from UCLA, title is "Melanoma Immunotherapy: What's next for Patients?" go to the question and answer section around 35min mark and he answers some questions and talks about vaccines. Dr. Ribas is one of the Dr.s behind the research and testing of Keytruda( pd-1) drug.Wishing you the best!!! Ed

                                            ed williams
                                            Participant

                                              It is pretty deep material, that is why I was dirrecting you to the question and answer section. If you want another idea in the same group of webinars, there is one from Dr. Ribas from UCLA, title is "Melanoma Immunotherapy: What's next for Patients?" go to the question and answer section around 35min mark and he answers some questions and talks about vaccines. Dr. Ribas is one of the Dr.s behind the research and testing of Keytruda( pd-1) drug.Wishing you the best!!! Ed

                                              ed williams
                                              Participant

                                                It is pretty deep material, that is why I was dirrecting you to the question and answer section. If you want another idea in the same group of webinars, there is one from Dr. Ribas from UCLA, title is "Melanoma Immunotherapy: What's next for Patients?" go to the question and answer section around 35min mark and he answers some questions and talks about vaccines. Dr. Ribas is one of the Dr.s behind the research and testing of Keytruda( pd-1) drug.Wishing you the best!!! Ed

                                                ET-SF
                                                Participant

                                                  Yes, it's deep indeed!  I'm no stranger to medical/physiological issues, having once been a scientist myself and having taught anatomy and physiology.  However, these immunology issues are an entirely different world from what I know!

                                                  ET and I will be watching at least several of these webinars as our headaches subside.  (Eventually I'll probably watch them all.)  It's been a bit like drinking from a fire hose, but I feel as though I'm getting a much better grasp of the issues (and so does she).  I did actually watch most of the Ribas webinar last night before being called away and then ultimately re-watching the Weber webinar with ET.  I hadn't gotten to the questions.

                                                  We now have more of a time frame:  Our initial appointment with Venna and Jang (Inova Fairfax Melanoma and Skin Cancer Center) is set up for Wed, Sept 9.  We'll have genetic test results to show them by that date.  Progress!

                                                  We're finally starting to catch our breath.  The last 3 weeks has been hell.  ET did some gardening yesterday (one of her many joys), and I actually slept in just a bit this morning.  We caught a movie on Netflix this weekend.  Much needed respite from the rigors of researching this hidden monster.

                                                  Thanks for your help, Ed!

                                                  SF

                                                  ET-SF
                                                  Participant

                                                    Yes, it's deep indeed!  I'm no stranger to medical/physiological issues, having once been a scientist myself and having taught anatomy and physiology.  However, these immunology issues are an entirely different world from what I know!

                                                    ET and I will be watching at least several of these webinars as our headaches subside.  (Eventually I'll probably watch them all.)  It's been a bit like drinking from a fire hose, but I feel as though I'm getting a much better grasp of the issues (and so does she).  I did actually watch most of the Ribas webinar last night before being called away and then ultimately re-watching the Weber webinar with ET.  I hadn't gotten to the questions.

                                                    We now have more of a time frame:  Our initial appointment with Venna and Jang (Inova Fairfax Melanoma and Skin Cancer Center) is set up for Wed, Sept 9.  We'll have genetic test results to show them by that date.  Progress!

                                                    We're finally starting to catch our breath.  The last 3 weeks has been hell.  ET did some gardening yesterday (one of her many joys), and I actually slept in just a bit this morning.  We caught a movie on Netflix this weekend.  Much needed respite from the rigors of researching this hidden monster.

                                                    Thanks for your help, Ed!

                                                    SF

                                                    ET-SF
                                                    Participant

                                                      Yes, it's deep indeed!  I'm no stranger to medical/physiological issues, having once been a scientist myself and having taught anatomy and physiology.  However, these immunology issues are an entirely different world from what I know!

                                                      ET and I will be watching at least several of these webinars as our headaches subside.  (Eventually I'll probably watch them all.)  It's been a bit like drinking from a fire hose, but I feel as though I'm getting a much better grasp of the issues (and so does she).  I did actually watch most of the Ribas webinar last night before being called away and then ultimately re-watching the Weber webinar with ET.  I hadn't gotten to the questions.

                                                      We now have more of a time frame:  Our initial appointment with Venna and Jang (Inova Fairfax Melanoma and Skin Cancer Center) is set up for Wed, Sept 9.  We'll have genetic test results to show them by that date.  Progress!

                                                      We're finally starting to catch our breath.  The last 3 weeks has been hell.  ET did some gardening yesterday (one of her many joys), and I actually slept in just a bit this morning.  We caught a movie on Netflix this weekend.  Much needed respite from the rigors of researching this hidden monster.

                                                      Thanks for your help, Ed!

                                                      SF

                                                    ed williams
                                                    Participant

                                                      Hi ET-SF, I thought you might like to get some up to date findings on Vaccines from one of the experts in the Melanoma field. Dr. Jeffrey S Webber of Moffit Cancer Center speaks on a webinar from 'Cancer Research Institute." How to find the webinar is easy, after you find the Cancer Research Institute home page go over to right side of page and click on "News and Publications" , then pick webinars and you will get serval to choose from. Dr. Weber speaks about Vaccines at the 46.30 min mark of the webinar titled "Cancer Revealed How our Immune systems sees and destroys tumors." Hope this will help in making your decision. Wishing you the best!!! Ed

                                                      ed williams
                                                      Participant

                                                        Hi ET-SF, I thought you might like to get some up to date findings on Vaccines from one of the experts in the Melanoma field. Dr. Jeffrey S Webber of Moffit Cancer Center speaks on a webinar from 'Cancer Research Institute." How to find the webinar is easy, after you find the Cancer Research Institute home page go over to right side of page and click on "News and Publications" , then pick webinars and you will get serval to choose from. Dr. Weber speaks about Vaccines at the 46.30 min mark of the webinar titled "Cancer Revealed How our Immune systems sees and destroys tumors." Hope this will help in making your decision. Wishing you the best!!! Ed

                                                        red_bean
                                                        Participant

                                                          you should look into

                                                           

                                                          NCT02054520

                                                          A Phase IIB Study of Ipilimumab With or Without Dorgenmeltucel-L (HyperAcute Melanoma) Immunotherapy for Stage IV Melanoma Patients

                                                           
                                                          red_bean
                                                          Participant

                                                            you should look into

                                                             

                                                            NCT02054520

                                                            A Phase IIB Study of Ipilimumab With or Without Dorgenmeltucel-L (HyperAcute Melanoma) Immunotherapy for Stage IV Melanoma Patients

                                                             
                                                              ET-SF
                                                              Participant

                                                                Thank you very much for searching that for me, but I think I miscommunicated.  We're looking for a study for stage IIb melanoma, not a phase IIb study for melanoma.  This study is for stage IV subjects.  Thankfully we're ot that far down the road!  πŸ˜‰

                                                                ET-SF
                                                                Participant

                                                                  Thank you very much for searching that for me, but I think I miscommunicated.  We're looking for a study for stage IIb melanoma, not a phase IIb study for melanoma.  This study is for stage IV subjects.  Thankfully we're ot that far down the road!  πŸ˜‰

                                                                  ET-SF
                                                                  Participant

                                                                    Thank you very much for searching that for me, but I think I miscommunicated.  We're looking for a study for stage IIb melanoma, not a phase IIb study for melanoma.  This study is for stage IV subjects.  Thankfully we're ot that far down the road!  πŸ˜‰

                                                                  red_bean
                                                                  Participant

                                                                    you should look into

                                                                     

                                                                    NCT02054520

                                                                    A Phase IIB Study of Ipilimumab With or Without Dorgenmeltucel-L (HyperAcute Melanoma) Immunotherapy for Stage IV Melanoma Patients

                                                                     
                                                                    _Paul_
                                                                    Participant

                                                                      Hi SF. I was a participant in the GVAX trial at Hopkins. I was in a similar boat to ET. I was Stage 3a being offered interferon or watch and wait and neither of those seemed palatable. That was 3 years ago and then someone on this board pointed out the GVAX trial. You can tell I was highly motivated since I live in Seattle and the trial is being conducted in Baltimore.

                                                                      In may case I still progressed while on the trial. In fact it was Dr. Lipson who noticed what proved to be a recurrence on my scalp during one his very thorough exams before each treatment. So even though it did not work in my case, you have to consider it is anecdotal evidence and not statistically significant.

                                                                      Anyway Dr. Lipson and the trial nurse Susan Sartorious are both top notch and you would be receiving excellent care while in their hands. I received 4 intradermal shots each treatment which did sting a bit – comparable to a bee sting followed by a bag of cytotoxin (the chemo part). I tolerated it very well. Felt a little cruddy the day of the treatment but the following day would feel like my old self.

                                                                      – Paul

                                                                      _Paul_
                                                                      Participant

                                                                        Hi SF. I was a participant in the GVAX trial at Hopkins. I was in a similar boat to ET. I was Stage 3a being offered interferon or watch and wait and neither of those seemed palatable. That was 3 years ago and then someone on this board pointed out the GVAX trial. You can tell I was highly motivated since I live in Seattle and the trial is being conducted in Baltimore.

                                                                        In may case I still progressed while on the trial. In fact it was Dr. Lipson who noticed what proved to be a recurrence on my scalp during one his very thorough exams before each treatment. So even though it did not work in my case, you have to consider it is anecdotal evidence and not statistically significant.

                                                                        Anyway Dr. Lipson and the trial nurse Susan Sartorious are both top notch and you would be receiving excellent care while in their hands. I received 4 intradermal shots each treatment which did sting a bit – comparable to a bee sting followed by a bag of cytotoxin (the chemo part). I tolerated it very well. Felt a little cruddy the day of the treatment but the following day would feel like my old self.

                                                                        – Paul

                                                                          ET-SF
                                                                          Participant

                                                                            Hi Paul,

                                                                            Thanks for writing about your experiences in the GVAX trial!  I feel a bit of connection, because I actually re-read Lipson's paper about the study last night.  I think that vaccine was/is a very creative idea.  It's a pity it didn't work any better.

                                                                            My take on vaccines is that the vicious dogs (CD8+ T cells) you might unleash with checkpoint blockade inhibitors won't know what to attack if your immune system isn't well trained.  So I don't think vaccines could ever be a wasted effort.

                                                                            After a lot of soul searching, I think ET has decided to participate in the big Polynoma POL-103a phase III trial at Inova.  Odds are good (2 out of 3) that ET won't fall into the placebo group.  We have our first evaluative appointment tomorrow morning and are very excited.  It's been a long journey to get to this point.  Everything seems to move at the speed of molasses. 

                                                                            Mostly we're relieved to get into the door of a good oncologist.  ET still hasn't had the full-body imaging to search for metastases.  I suppose nobody wants to be the physician to hand the big bill to the insurance company, so the can gets kicked down the road to the oncologist.  The waiting is so hard.

                                                                            I had emailed my advisor (from grad school) about ET.  It seems he is dealing with multiple myeloma, but is currently NED.  He said the best part about participating in these studies is the monitoring — that you are tested, poked, prodded, and scrutinized very thoroughly, so any little surprises will be caught early.

                                                                            ET-SF
                                                                            Participant

                                                                              Hi Paul,

                                                                              Thanks for writing about your experiences in the GVAX trial!  I feel a bit of connection, because I actually re-read Lipson's paper about the study last night.  I think that vaccine was/is a very creative idea.  It's a pity it didn't work any better.

                                                                              My take on vaccines is that the vicious dogs (CD8+ T cells) you might unleash with checkpoint blockade inhibitors won't know what to attack if your immune system isn't well trained.  So I don't think vaccines could ever be a wasted effort.

                                                                              After a lot of soul searching, I think ET has decided to participate in the big Polynoma POL-103a phase III trial at Inova.  Odds are good (2 out of 3) that ET won't fall into the placebo group.  We have our first evaluative appointment tomorrow morning and are very excited.  It's been a long journey to get to this point.  Everything seems to move at the speed of molasses. 

                                                                              Mostly we're relieved to get into the door of a good oncologist.  ET still hasn't had the full-body imaging to search for metastases.  I suppose nobody wants to be the physician to hand the big bill to the insurance company, so the can gets kicked down the road to the oncologist.  The waiting is so hard.

                                                                              I had emailed my advisor (from grad school) about ET.  It seems he is dealing with multiple myeloma, but is currently NED.  He said the best part about participating in these studies is the monitoring — that you are tested, poked, prodded, and scrutinized very thoroughly, so any little surprises will be caught early.

                                                                              Bigdaddy5
                                                                              Participant

                                                                                Hi:

                                                                                I was diagnosed IIb and have Drs Venna and Jang as well. I am interested in whether ET got selected for pol-103a phase 3 trial?

                                                                                Sincerely,

                                                                                Neil D

                                                                                Bigdaddy5
                                                                                Participant

                                                                                  Hi:

                                                                                  I was diagnosed IIb and have Drs Venna and Jang as well. I am interested in whether ET got selected for pol-103a phase 3 trial?

                                                                                  Sincerely,

                                                                                  Neil D

                                                                                  Bigdaddy5
                                                                                  Participant

                                                                                    Hi:

                                                                                    I was diagnosed IIb and have Drs Venna and Jang as well. I am interested in whether ET got selected for pol-103a phase 3 trial?

                                                                                    Sincerely,

                                                                                    Neil D

                                                                                    ET-SF
                                                                                    Participant

                                                                                      Hi Paul,

                                                                                      Thanks for writing about your experiences in the GVAX trial!  I feel a bit of connection, because I actually re-read Lipson's paper about the study last night.  I think that vaccine was/is a very creative idea.  It's a pity it didn't work any better.

                                                                                      My take on vaccines is that the vicious dogs (CD8+ T cells) you might unleash with checkpoint blockade inhibitors won't know what to attack if your immune system isn't well trained.  So I don't think vaccines could ever be a wasted effort.

                                                                                      After a lot of soul searching, I think ET has decided to participate in the big Polynoma POL-103a phase III trial at Inova.  Odds are good (2 out of 3) that ET won't fall into the placebo group.  We have our first evaluative appointment tomorrow morning and are very excited.  It's been a long journey to get to this point.  Everything seems to move at the speed of molasses. 

                                                                                      Mostly we're relieved to get into the door of a good oncologist.  ET still hasn't had the full-body imaging to search for metastases.  I suppose nobody wants to be the physician to hand the big bill to the insurance company, so the can gets kicked down the road to the oncologist.  The waiting is so hard.

                                                                                      I had emailed my advisor (from grad school) about ET.  It seems he is dealing with multiple myeloma, but is currently NED.  He said the best part about participating in these studies is the monitoring — that you are tested, poked, prodded, and scrutinized very thoroughly, so any little surprises will be caught early.

                                                                                    _Paul_
                                                                                    Participant

                                                                                      Hi SF. I was a participant in the GVAX trial at Hopkins. I was in a similar boat to ET. I was Stage 3a being offered interferon or watch and wait and neither of those seemed palatable. That was 3 years ago and then someone on this board pointed out the GVAX trial. You can tell I was highly motivated since I live in Seattle and the trial is being conducted in Baltimore.

                                                                                      In may case I still progressed while on the trial. In fact it was Dr. Lipson who noticed what proved to be a recurrence on my scalp during one his very thorough exams before each treatment. So even though it did not work in my case, you have to consider it is anecdotal evidence and not statistically significant.

                                                                                      Anyway Dr. Lipson and the trial nurse Susan Sartorious are both top notch and you would be receiving excellent care while in their hands. I received 4 intradermal shots each treatment which did sting a bit – comparable to a bee sting followed by a bag of cytotoxin (the chemo part). I tolerated it very well. Felt a little cruddy the day of the treatment but the following day would feel like my old self.

                                                                                      – Paul

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