› Forums › General Melanoma Community › Interleukin-21 Phase I and II trials.
- This topic has 10 replies, 3 voices, and was last updated 13 years, 5 months ago by
JerryfromFauq.
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- June 8, 2011 at 5:00 pm
Good afternoon everyone.
I would like to point out that IL-2 and IL-21 are not the same. Interleukin–21 is a protein that in humans is encoded by the IL21 gene and is a experimental drug which is currently in clinical trials.
Good afternoon everyone.
I would like to point out that IL-2 and IL-21 are not the same. Interleukin–21 is a protein that in humans is encoded by the IL21 gene and is a experimental drug which is currently in clinical trials.
IL-21 was approved for clinical trials in metastatic melanoma and renal cell carcinoma patients. It was shown to be safe for administration with flu-like symptoms as side effects. Dose-limiting toxicities included low lymphocyte, neutrophil, and thrombocyte count as well as hepatotoxicity. According to the Response Evaluation Criteria in Solid Tumors (RECIST) response scale, 2 out of 47 MM patients and 4 out of 19 RCC patients showed complete and partial responses, respectively. In addition, there was an increase of peforin, granzyme B, IFN-Y, and CXCR3 mRNA in peripheral NK cells and CD8+ T-cells. This suggested that IL-21 enhances the CD8+ effector functions thus leading to anti-tumor response. IL-21 proceeded to Phase 2 clinical trials where it was administered alone or coupled with drugs as sorafinib and rituximab.
Here is the trial:
http://clinicaltrials.gov/ct2/show/NCT01152788?term=il-21+melanoma&recr=Open&rank=1
There is also a phase II trial, but it is not recruiting patients at this time.
Michael
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- June 9, 2011 at 12:29 am
Nice to see you post this Michael. My team and I have played with not only IL2, but 7, 11 as well as the 21 you mentioned for some time.
Each one in the interleukine chain serves a different purpose and function with many others yet only are "thought" to do something but not definitive, but there are clear suggestions of symbiotic activity.
That said, there IS an important interplay in my opinion, from my one person clinical trial.
I might add, that these interleukins are widely available sans trials, but it surely takes a trusted team and forward thinking tumor board to get them,,,,,,,,,,,,,,,,but you CAN get them………..and certainly at ones own risk.
Cheers,
Charlie S
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- June 9, 2011 at 1:44 am
I'm not always clear,,,,,so let me clear that up !
I HAVE done IL2, I HAVE done IL7, 11 and 21 through a variety of methods, and I will do so again if it makes sense to me.
For many reasons I hold my medical decisions close to my vest because they have only applied to me, for my particular circumstances and according to my own best judgement…………………….and often my best judgement is at odds with conventional approaches to melanoma, but I get what I want and it has always been supported and approved by the medical reasoning of physicians.
Yes, there is risk involved and yes it is unconventional and no you just can't waltz into the docs office and say " hey, how about hittin' me up with this".
So YES I have done them, and YES under the right circumstance would do them again, NO there is no need to get them via a trial, but due to the risk, not every doc is going to be willing to do that for you.
Clear as mud, huh?
Cheers,
Charlie S
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- June 11, 2011 at 11:04 am
Yeah Charley, I thought you were very clear. I still wonder why more direct injections are not done in individual tumors. I hve a new tumor I just found last week. It’s about 2 cm across in my right chest. I will see my Onc Monday and get a T then. I have to decide if I want it cut out or try direct injections and what the Onc is willing to do. Wish me luck. Thanks for all your words. -
- June 11, 2011 at 11:04 am
Yeah Charley, I thought you were very clear. I still wonder why more direct injections are not done in individual tumors. I hve a new tumor I just found last week. It’s about 2 cm across in my right chest. I will see my Onc Monday and get a T then. I have to decide if I want it cut out or try direct injections and what the Onc is willing to do. Wish me luck. Thanks for all your words. -
- June 9, 2011 at 1:44 am
I'm not always clear,,,,,so let me clear that up !
I HAVE done IL2, I HAVE done IL7, 11 and 21 through a variety of methods, and I will do so again if it makes sense to me.
For many reasons I hold my medical decisions close to my vest because they have only applied to me, for my particular circumstances and according to my own best judgement…………………….and often my best judgement is at odds with conventional approaches to melanoma, but I get what I want and it has always been supported and approved by the medical reasoning of physicians.
Yes, there is risk involved and yes it is unconventional and no you just can't waltz into the docs office and say " hey, how about hittin' me up with this".
So YES I have done them, and YES under the right circumstance would do them again, NO there is no need to get them via a trial, but due to the risk, not every doc is going to be willing to do that for you.
Clear as mud, huh?
Cheers,
Charlie S
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- June 9, 2011 at 12:29 am
Nice to see you post this Michael. My team and I have played with not only IL2, but 7, 11 as well as the 21 you mentioned for some time.
Each one in the interleukine chain serves a different purpose and function with many others yet only are "thought" to do something but not definitive, but there are clear suggestions of symbiotic activity.
That said, there IS an important interplay in my opinion, from my one person clinical trial.
I might add, that these interleukins are widely available sans trials, but it surely takes a trusted team and forward thinking tumor board to get them,,,,,,,,,,,,,,,,but you CAN get them………..and certainly at ones own risk.
Cheers,
Charlie S
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