Interferon/Ipi trial question

My husband is entering this same trial.  The way we looked at it, the very least we can get is the treatment he would be doing anyways.  This at least offers him a chance to get the newest drug on the market.

My husband is entering this same trial.  The way we looked at it, the very least we can get is the treatment he would be doing anyways.  This at least offers him a chance to get the newest drug on the market.

My husband is entering this same trial.  The way we looked at it, the very least we can get is the treatment he would be doing anyways.  This at least offers him a chance to get the newest drug on the market.

Hi Brad,

You might look at the thread on "the ethics of crlinical trial participation" related to this study that started on 11/1/2011. I don't think anyone has really been able to articulate an good answer about why this might be a desirable trial structure, so it's a very good question.

Paul

Hi Brad,

You might look at the thread on "the ethics of crlinical trial participation" related to this study that started on 11/1/2011. I don't think anyone has really been able to articulate an good answer about why this might be a desirable trial structure, so it's a very good question.

Paul

Hi Brad,

You might look at the thread on "the ethics of crlinical trial participation" related to this study that started on 11/1/2011. I don't think anyone has really been able to articulate an good answer about why this might be a desirable trial structure, so it's a very good question.

Paul

Hi Brad,

You might look at the thread on "the ethics of crlinical trial participation" related to this study that started on 11/1/2011. I don't think anyone has really been able to articulate an good answer about why this might be a desirable trial structure, so it's a very good question.

Paul

Hi Brad,

You might look at the thread on "the ethics of crlinical trial participation" related to this study that started on 11/1/2011. I don't think anyone has really been able to articulate an good answer about why this might be a desirable trial structure, so it's a very good question.

Paul

Hi Brad,

You might look at the thread on "the ethics of crlinical trial participation" related to this study that started on 11/1/2011. I don't think anyone has really been able to articulate an good answer about why this might be a desirable trial structure, so it's a very good question.

Paul

I believe in trials it is customary to put a drug against either a placebo or the standard of care. Interferon is approved for stage three as standard of care.

It even says right on the trial page:

Purpose:

Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers.

It is not yet known whether ipilimumab is more effective then interferon alfa-2b in treating patients with melanoma. 

I guess basically they are wanting to see how IPI does against interferon numbers.

I believe in trials it is customary to put a drug against either a placebo or the standard of care. Interferon is approved for stage three as standard of care.

It even says right on the trial page:

Purpose:

Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers.

It is not yet known whether ipilimumab is more effective then interferon alfa-2b in treating patients with melanoma. 

I guess basically they are wanting to see how IPI does against interferon numbers.

I believe in trials it is customary to put a drug against either a placebo or the standard of care. Interferon is approved for stage three as standard of care.

It even says right on the trial page:

Purpose:

Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers.

It is not yet known whether ipilimumab is more effective then interferon alfa-2b in treating patients with melanoma. 

I guess basically they are wanting to see how IPI does against interferon numbers.

I'm gonna take a stab at your question, and it is based upon my experience and not theory.  First, I was dx'd in 1987 Stage III Melanoma., went Stage IV in 1996 and have witnessed first hand and have had access to, the evolution of virtually EVERY attempt at a melanoma solution.  And still have active disease.

I have been exposed  to some of the best and brightest minds in the United States relative to melanoma treatment over these now almost 25 years.  At the time, it took almost six months via the use of an electron microscope  to even define my diagnosis at the time.

I was there when CT scans were still in development and the MRI , PET Scan and SNB had not yet even been imaginied.

I was there when LAX cell therapy, the pre-cursor to immunotherapy was being played with in an underfunded way because melanoma was then considered an orphan disease with a mortality rate of 100%.

Even the design, recruitment,  implementation,administration and management of clinical trials themselves as an avenue for FDA approval were under development then.

I'm neither bragging nor complaining, but I have been suffering from melanoma longer than many melanoma specialists have been in medical practise

So, that is the baselne of what I have to say to you.

Intron has been well studied.  IL-23 has been well studied.  Both, however were each "borrowed" treatments applied to melanoma.  Intron was developed as an answer to Hep-C, IL-2 was developed as an answer to Renal Cell Carcinoma. Even the SNB was borrowed from breast cancer.

Intron and IL-2 were approved for melanoma.  So, like it or not the FDA said Intron for Stage III and IL2 for Stage IV melanoma……………..in the meantime,inexplicably, DTIC somehow "shadowed' in as a general approach to all cancers and was widely administered.

Enter trie clinical trial  design.  Phase I a dose escalating exercise to determine the level a drug could be given without killing someone and defining what happened.  Phase II, enroll specific disease patients and see what happens and then………………PhaseIIII compare to the standard of care, do a blind draw to get the developmental drug or the standard of care.

For IPI, the path of least resistance for approval was NOT to compare it to Intron or IL2., but DTIC

Political and economic considerations aside, it was a wrong headed trial design for the melanoma patient, but right headed for approval of Ipilimumab and introduce a new therapy.

NOW, IPI is being stacked up against the true standard of care which is Intron for this trial.

Enroll in this trial and the patient is faced with the skepital results of Intron against IPI and the worst part, it is a roll of the dice to which one you get.

So, this trial, to me, is a back door way to compare IPI with the standard care for Stage III and make it the standard of care..  Which, aside from the disclaimers, should have been done in the first place rather than put the cop out of IPI being available for "unresectable" Stage III melanoma. , because if one reviews the science, Stage III melanoma, by its' very definition is metastatic and by extension, is unresectable..

In vogue today is to find synergy amongst available treatments.  This trial, to me, does not represent that trend, but rather is a corporate move for expanded use……………………..which does nothing for the patient.

I have done Intron, IL2 and have declined IPI with zero regrets.

Faced with what you have, there is a trial that basically throws everything, including the kitchen sink at melanoma.,

You want this trial of intron vs IPI?  Fine, if you are randomized into IPI, go for it.  Get intron, opt out  In my opinion, this trial will collapse, because there is a better one and nobody in their right mind would agree to it.

Long, to be sure, but this is how I look at things.

Cheers,

Charlie S

I'm gonna take a stab at your question, and it is based upon my experience and not theory.  First, I was dx'd in 1987 Stage III Melanoma., went Stage IV in 1996 and have witnessed first hand and have had access to, the evolution of virtually EVERY attempt at a melanoma solution.  And still have active disease.

I have been exposed  to some of the best and brightest minds in the United States relative to melanoma treatment over these now almost 25 years.  At the time, it took almost six months via the use of an electron microscope  to even define my diagnosis at the time.

I was there when CT scans were still in development and the MRI , PET Scan and SNB had not yet even been imaginied.

I was there when LAX cell therapy, the pre-cursor to immunotherapy was being played with in an underfunded way because melanoma was then considered an orphan disease with a mortality rate of 100%.

Even the design, recruitment,  implementation,administration and management of clinical trials themselves as an avenue for FDA approval were under development then.

I'm neither bragging nor complaining, but I have been suffering from melanoma longer than many melanoma specialists have been in medical practise

So, that is the baselne of what I have to say to you.

Intron has been well studied.  IL-23 has been well studied.  Both, however were each "borrowed" treatments applied to melanoma.  Intron was developed as an answer to Hep-C, IL-2 was developed as an answer to Renal Cell Carcinoma. Even the SNB was borrowed from breast cancer.

Intron and IL-2 were approved for melanoma.  So, like it or not the FDA said Intron for Stage III and IL2 for Stage IV melanoma……………..in the meantime,inexplicably, DTIC somehow "shadowed' in as a general approach to all cancers and was widely administered.

Enter trie clinical trial  design.  Phase I a dose escalating exercise to determine the level a drug could be given without killing someone and defining what happened.  Phase II, enroll specific disease patients and see what happens and then………………PhaseIIII compare to the standard of care, do a blind draw to get the developmental drug or the standard of care.

For IPI, the path of least resistance for approval was NOT to compare it to Intron or IL2., but DTIC

Political and economic considerations aside, it was a wrong headed trial design for the melanoma patient, but right headed for approval of Ipilimumab and introduce a new therapy.

NOW, IPI is being stacked up against the true standard of care which is Intron for this trial.

Enroll in this trial and the patient is faced with the skepital results of Intron against IPI and the worst part, it is a roll of the dice to which one you get.

So, this trial, to me, is a back door way to compare IPI with the standard care for Stage III and make it the standard of care..  Which, aside from the disclaimers, should have been done in the first place rather than put the cop out of IPI being available for "unresectable" Stage III melanoma. , because if one reviews the science, Stage III melanoma, by its' very definition is metastatic and by extension, is unresectable..

In vogue today is to find synergy amongst available treatments.  This trial, to me, does not represent that trend, but rather is a corporate move for expanded use……………………..which does nothing for the patient.

I have done Intron, IL2 and have declined IPI with zero regrets.

Faced with what you have, there is a trial that basically throws everything, including the kitchen sink at melanoma.,

You want this trial of intron vs IPI?  Fine, if you are randomized into IPI, go for it.  Get intron, opt out  In my opinion, this trial will collapse, because there is a better one and nobody in their right mind would agree to it.

Long, to be sure, but this is how I look at things.

Cheers,

Charlie S

I'm gonna take a stab at your question, and it is based upon my experience and not theory.  First, I was dx'd in 1987 Stage III Melanoma., went Stage IV in 1996 and have witnessed first hand and have had access to, the evolution of virtually EVERY attempt at a melanoma solution.  And still have active disease.

I have been exposed  to some of the best and brightest minds in the United States relative to melanoma treatment over these now almost 25 years.  At the time, it took almost six months via the use of an electron microscope  to even define my diagnosis at the time.

I was there when CT scans were still in development and the MRI , PET Scan and SNB had not yet even been imaginied.

I was there when LAX cell therapy, the pre-cursor to immunotherapy was being played with in an underfunded way because melanoma was then considered an orphan disease with a mortality rate of 100%.

Even the design, recruitment,  implementation,administration and management of clinical trials themselves as an avenue for FDA approval were under development then.

I'm neither bragging nor complaining, but I have been suffering from melanoma longer than many melanoma specialists have been in medical practise

So, that is the baselne of what I have to say to you.

Intron has been well studied.  IL-23 has been well studied.  Both, however were each "borrowed" treatments applied to melanoma.  Intron was developed as an answer to Hep-C, IL-2 was developed as an answer to Renal Cell Carcinoma. Even the SNB was borrowed from breast cancer.

Intron and IL-2 were approved for melanoma.  So, like it or not the FDA said Intron for Stage III and IL2 for Stage IV melanoma……………..in the meantime,inexplicably, DTIC somehow "shadowed' in as a general approach to all cancers and was widely administered.

Enter trie clinical trial  design.  Phase I a dose escalating exercise to determine the level a drug could be given without killing someone and defining what happened.  Phase II, enroll specific disease patients and see what happens and then………………PhaseIIII compare to the standard of care, do a blind draw to get the developmental drug or the standard of care.

For IPI, the path of least resistance for approval was NOT to compare it to Intron or IL2., but DTIC

Political and economic considerations aside, it was a wrong headed trial design for the melanoma patient, but right headed for approval of Ipilimumab and introduce a new therapy.

NOW, IPI is being stacked up against the true standard of care which is Intron for this trial.

Enroll in this trial and the patient is faced with the skepital results of Intron against IPI and the worst part, it is a roll of the dice to which one you get.

So, this trial, to me, is a back door way to compare IPI with the standard care for Stage III and make it the standard of care..  Which, aside from the disclaimers, should have been done in the first place rather than put the cop out of IPI being available for "unresectable" Stage III melanoma. , because if one reviews the science, Stage III melanoma, by its' very definition is metastatic and by extension, is unresectable..

In vogue today is to find synergy amongst available treatments.  This trial, to me, does not represent that trend, but rather is a corporate move for expanded use……………………..which does nothing for the patient.

I have done Intron, IL2 and have declined IPI with zero regrets.

Faced with what you have, there is a trial that basically throws everything, including the kitchen sink at melanoma.,

You want this trial of intron vs IPI?  Fine, if you are randomized into IPI, go for it.  Get intron, opt out  In my opinion, this trial will collapse, because there is a better one and nobody in their right mind would agree to it.

Long, to be sure, but this is how I look at things.

Cheers,

Charlie S

I was going to sy a little of what Charlie said.  But cannot say anything like the total with his great coverage.  I will try to Emphase why i think they want this trial   "This trial, to me, is a back door way to compare IPI with the standard care for Stage III and make it the standard of care..  Which, aside from the disclaimers, should have been done in the first place rather than put the cop out of IPI being available for "unresectable" Stage III melanoma." 

   I have long thought that Ipi should be available across the board for Stage III.  Since Intron is the only approved Stage III systemic treatment,  It should have been included in the original trials.  I suspect that it will wind up being approved as an Stage III treatment and will exceed the benefit of Intron.  How much difference in the numbers will be very interesting to see, but I suspect it will be statistically significant. (Not as high as we would like, but still should be an improvement for reduced progression of stage III.patients.

I was going to sy a little of what Charlie said.  But cannot say anything like the total with his great coverage.  I will try to Emphase why i think they want this trial   "This trial, to me, is a back door way to compare IPI with the standard care for Stage III and make it the standard of care..  Which, aside from the disclaimers, should have been done in the first place rather than put the cop out of IPI being available for "unresectable" Stage III melanoma." 

   I have long thought that Ipi should be available across the board for Stage III.  Since Intron is the only approved Stage III systemic treatment,  It should have been included in the original trials.  I suspect that it will wind up being approved as an Stage III treatment and will exceed the benefit of Intron.  How much difference in the numbers will be very interesting to see, but I suspect it will be statistically significant. (Not as high as we would like, but still should be an improvement for reduced progression of stage III.patients.

I was going to sy a little of what Charlie said.  But cannot say anything like the total with his great coverage.  I will try to Emphase why i think they want this trial   "This trial, to me, is a back door way to compare IPI with the standard care for Stage III and make it the standard of care..  Which, aside from the disclaimers, should have been done in the first place rather than put the cop out of IPI being available for "unresectable" Stage III melanoma." 

   I have long thought that Ipi should be available across the board for Stage III.  Since Intron is the only approved Stage III systemic treatment,  It should have been included in the original trials.  I suspect that it will wind up being approved as an Stage III treatment and will exceed the benefit of Intron.  How much difference in the numbers will be very interesting to see, but I suspect it will be statistically significant. (Not as high as we would like, but still should be an improvement for reduced progression of stage III.patients.