› Forums › General Melanoma Community › High Dose Interferon and Ipi Trial
- This topic has 42 replies, 10 voices, and was last updated 8 years, 11 months ago by
BrianP.
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- May 11, 2015 at 10:57 pm
My mother was recently diagnosed with Stage III melanoma, primary site unknown. She had a small mass in her right parotid that her ENT orginally though was benign. During her surgery on April 2, 2015 the doctor was concerned with the appearance of the mass and a frozen biospy was completed. Orginal diagnosis was non-oat cell Small Cell Carcinoma. It was two weeks later and path results going to Mayo that they confirmed she had Melanoma. Her orignal surgery was converted into a total parotidectomy and level I and IIb dissection. PET/CT scans just confirmed she still has three localized lymph nodes positive with melanoma and MRI was clear. We are seeing the melanoma specialist and he has suggested my mother participate in a clinical trial where she will be started on High dose interferon for four week five days per week which then moves to the standard three SQ injections per week with Ipi every three weeks two infusions. The trial is around 3 or 10 mg doses of ipi, and she would then receive the radical neck dissection on week six. Afterward she would go into a maintenance phase of the interferon with SQ injections and the Ipi would eventually be given every 12 weeks for the entire study for approx. one year.
I am concerned about the delay in the radical neck dissection for six weeks and knowing all the side effects with the study.
Is there anyone else who is going through this study right now, or any one have additional insight?
- Replies
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- May 12, 2015 at 4:41 am
My husband was in this trial . It sounds like you are a bit confused about the trial or it is different from his. He was in the 10 mg arm and is NED now after having"progression "" after the initial ipi infusions. He managed the side effects. Read. My posts for more info. Good luck
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- May 12, 2015 at 4:41 am
My husband was in this trial . It sounds like you are a bit confused about the trial or it is different from his. He was in the 10 mg arm and is NED now after having"progression "" after the initial ipi infusions. He managed the side effects. Read. My posts for more info. Good luck
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- May 12, 2015 at 12:27 pm
The trial they want my mother in she will receive both treatments at the same time (ipi and interferon). The ipi is randomized to either 10 mg or 3 mg arm. Then after the "Induction" phase (six weeks) she will have a right total neck dissection.
when your husband was on the 10 mg how did he tolerate the ipi? Any major side effects?
Thanks so much for responding. I have been in the medical field for 13 years but non of my focus was in oncology so this forum has been very helpful to hear from others.
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- May 14, 2015 at 11:36 am
How old is your mother and how good is her health ?
This is very heavy duty and a very toxic combination of therapies.
No way would I do it.
If you cant get something like keytruda I wouldnt bother.
I would have the surgery and wait and recover.
And then look at other options.
Too much potential for bad side effects and both ipi and interferon dont have great statistics when it comes to long term disease free survival.
Always ask for the statistics and always ask for the side effects. In this case i dont reckon it is worth the risk of your current health and a small chance of increasing OS.
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- May 14, 2015 at 11:36 am
How old is your mother and how good is her health ?
This is very heavy duty and a very toxic combination of therapies.
No way would I do it.
If you cant get something like keytruda I wouldnt bother.
I would have the surgery and wait and recover.
And then look at other options.
Too much potential for bad side effects and both ipi and interferon dont have great statistics when it comes to long term disease free survival.
Always ask for the statistics and always ask for the side effects. In this case i dont reckon it is worth the risk of your current health and a small chance of increasing OS.
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- May 14, 2015 at 11:36 am
How old is your mother and how good is her health ?
This is very heavy duty and a very toxic combination of therapies.
No way would I do it.
If you cant get something like keytruda I wouldnt bother.
I would have the surgery and wait and recover.
And then look at other options.
Too much potential for bad side effects and both ipi and interferon dont have great statistics when it comes to long term disease free survival.
Always ask for the statistics and always ask for the side effects. In this case i dont reckon it is worth the risk of your current health and a small chance of increasing OS.
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- May 14, 2015 at 1:32 pm
Hi,
Sorry about your mother. My husband didn't have any experience for the interferon but did have Ipi at the 10 mg/kg and he did great. Mostly small side effects and was in the clinical trial with Ipi and GMCSF.
He started in March 2011 and became NED (no evidence of disease) by Oct 2012 and he was stage IV when he started with metasis in the liver and lungs and a unresectable lesion pushing on the C1 C2 cervical spine (which would have left him a quadriplegic if he had surgery) and 4 surface sub q's which we watched shrink away.
Squash, just for your information not everyone gets a bad reaction. My husband was 59 years old when he started the trial. He has been NED for 2 1/2 years and who knows how long it will last but he is doing good.
But like I just said everyones reaction to the drugs is different. He also make sure his Vitamin D3 levels remain high and he attributes this to helping him. If you wish to read more about his journey it is in his profile.
Judy (loving wife of Gene Stage IV and now NED)
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- May 14, 2015 at 1:32 pm
Hi,
Sorry about your mother. My husband didn't have any experience for the interferon but did have Ipi at the 10 mg/kg and he did great. Mostly small side effects and was in the clinical trial with Ipi and GMCSF.
He started in March 2011 and became NED (no evidence of disease) by Oct 2012 and he was stage IV when he started with metasis in the liver and lungs and a unresectable lesion pushing on the C1 C2 cervical spine (which would have left him a quadriplegic if he had surgery) and 4 surface sub q's which we watched shrink away.
Squash, just for your information not everyone gets a bad reaction. My husband was 59 years old when he started the trial. He has been NED for 2 1/2 years and who knows how long it will last but he is doing good.
But like I just said everyones reaction to the drugs is different. He also make sure his Vitamin D3 levels remain high and he attributes this to helping him. If you wish to read more about his journey it is in his profile.
Judy (loving wife of Gene Stage IV and now NED)
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- May 14, 2015 at 1:32 pm
Hi,
Sorry about your mother. My husband didn't have any experience for the interferon but did have Ipi at the 10 mg/kg and he did great. Mostly small side effects and was in the clinical trial with Ipi and GMCSF.
He started in March 2011 and became NED (no evidence of disease) by Oct 2012 and he was stage IV when he started with metasis in the liver and lungs and a unresectable lesion pushing on the C1 C2 cervical spine (which would have left him a quadriplegic if he had surgery) and 4 surface sub q's which we watched shrink away.
Squash, just for your information not everyone gets a bad reaction. My husband was 59 years old when he started the trial. He has been NED for 2 1/2 years and who knows how long it will last but he is doing good.
But like I just said everyones reaction to the drugs is different. He also make sure his Vitamin D3 levels remain high and he attributes this to helping him. If you wish to read more about his journey it is in his profile.
Judy (loving wife of Gene Stage IV and now NED)
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- May 12, 2015 at 12:27 pm
The trial they want my mother in she will receive both treatments at the same time (ipi and interferon). The ipi is randomized to either 10 mg or 3 mg arm. Then after the "Induction" phase (six weeks) she will have a right total neck dissection.
when your husband was on the 10 mg how did he tolerate the ipi? Any major side effects?
Thanks so much for responding. I have been in the medical field for 13 years but non of my focus was in oncology so this forum has been very helpful to hear from others.
-
- May 12, 2015 at 12:27 pm
The trial they want my mother in she will receive both treatments at the same time (ipi and interferon). The ipi is randomized to either 10 mg or 3 mg arm. Then after the "Induction" phase (six weeks) she will have a right total neck dissection.
when your husband was on the 10 mg how did he tolerate the ipi? Any major side effects?
Thanks so much for responding. I have been in the medical field for 13 years but non of my focus was in oncology so this forum has been very helpful to hear from others.
-
- May 12, 2015 at 4:41 am
My husband was in this trial . It sounds like you are a bit confused about the trial or it is different from his. He was in the 10 mg arm and is NED now after having"progression "" after the initial ipi infusions. He managed the side effects. Read. My posts for more info. Good luck
-
- May 14, 2015 at 5:30 pm
I'd look to get in the Ipi vs. Nivo tria that's happening now as Ipi alone is effective and Nivo (another PD-1 blocker) has the potential to be more effective and less toxic like Pembro. In a recent study, Pembo beat Ipi so well they ended the study and moved those on Ipi to Pembro. Doesn't mean Ipi is not good, it's just that Pembor was much better. Nivo is expected to be the same.
Steve
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- May 14, 2015 at 5:30 pm
I'd look to get in the Ipi vs. Nivo tria that's happening now as Ipi alone is effective and Nivo (another PD-1 blocker) has the potential to be more effective and less toxic like Pembro. In a recent study, Pembo beat Ipi so well they ended the study and moved those on Ipi to Pembro. Doesn't mean Ipi is not good, it's just that Pembor was much better. Nivo is expected to be the same.
Steve
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- May 14, 2015 at 9:13 pm
Two years ago, at the age of 71, I was diagnosed with malignant metastatic melanoma in my left parotid gland. There was no evidence of a primary melanoma on my skin and the PET Scan showed the 2.5 cm lesion on my left parotid gland as the only site of a malignancy. Three weeks later, I had a left total parotidectomy and left supraomohyoid neck dissection (levels 1 through 3). After the surgery I was NED (no evidence of disease) and was eligible to take part in Clinical Trial ECOG E1609: A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma. Arm A received 10 milligrams ipilimumab per Kilogram body weight; Arm C received 3 mg/Kg; Arm B received the Interferon. You can look up the study chart for more detail.
I was randomized into Arm C. I received only two infusions of ipilimumab at 3 mg/Kg because I had a strong irAE, immune related Adverse Event. Treatment was stopped. My reactions were dealt with, and I am still in the study. I get regular CT Scans and blood work. I have been NED since the surgery.
I am not familiar with the study being proposed to your mother. There is usually a comprehensive protocol to be signed before participation in a clinical trial begins. It should be read very carefully and all questions answered to your satisfaction before signing.
Your mother and your family have my very best wishes.
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- May 14, 2015 at 9:13 pm
Two years ago, at the age of 71, I was diagnosed with malignant metastatic melanoma in my left parotid gland. There was no evidence of a primary melanoma on my skin and the PET Scan showed the 2.5 cm lesion on my left parotid gland as the only site of a malignancy. Three weeks later, I had a left total parotidectomy and left supraomohyoid neck dissection (levels 1 through 3). After the surgery I was NED (no evidence of disease) and was eligible to take part in Clinical Trial ECOG E1609: A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma. Arm A received 10 milligrams ipilimumab per Kilogram body weight; Arm C received 3 mg/Kg; Arm B received the Interferon. You can look up the study chart for more detail.
I was randomized into Arm C. I received only two infusions of ipilimumab at 3 mg/Kg because I had a strong irAE, immune related Adverse Event. Treatment was stopped. My reactions were dealt with, and I am still in the study. I get regular CT Scans and blood work. I have been NED since the surgery.
I am not familiar with the study being proposed to your mother. There is usually a comprehensive protocol to be signed before participation in a clinical trial begins. It should be read very carefully and all questions answered to your satisfaction before signing.
Your mother and your family have my very best wishes.
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- May 14, 2015 at 9:13 pm
Two years ago, at the age of 71, I was diagnosed with malignant metastatic melanoma in my left parotid gland. There was no evidence of a primary melanoma on my skin and the PET Scan showed the 2.5 cm lesion on my left parotid gland as the only site of a malignancy. Three weeks later, I had a left total parotidectomy and left supraomohyoid neck dissection (levels 1 through 3). After the surgery I was NED (no evidence of disease) and was eligible to take part in Clinical Trial ECOG E1609: A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma. Arm A received 10 milligrams ipilimumab per Kilogram body weight; Arm C received 3 mg/Kg; Arm B received the Interferon. You can look up the study chart for more detail.
I was randomized into Arm C. I received only two infusions of ipilimumab at 3 mg/Kg because I had a strong irAE, immune related Adverse Event. Treatment was stopped. My reactions were dealt with, and I am still in the study. I get regular CT Scans and blood work. I have been NED since the surgery.
I am not familiar with the study being proposed to your mother. There is usually a comprehensive protocol to be signed before participation in a clinical trial begins. It should be read very carefully and all questions answered to your satisfaction before signing.
Your mother and your family have my very best wishes.
-
- May 14, 2015 at 5:30 pm
I'd look to get in the Ipi vs. Nivo tria that's happening now as Ipi alone is effective and Nivo (another PD-1 blocker) has the potential to be more effective and less toxic like Pembro. In a recent study, Pembo beat Ipi so well they ended the study and moved those on Ipi to Pembro. Doesn't mean Ipi is not good, it's just that Pembor was much better. Nivo is expected to be the same.
Steve
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- May 14, 2015 at 9:58 pm
That would be a very intense treatment to be on both. I am nearing the end of interferon therapy and am looking forward to getting back to normal.
Good luck to your mom – this is a complex diagnosis and the treatments are even more confusing! Luckily this is a time of lots of hope and excitement around melanoma treatments.
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- May 14, 2015 at 9:58 pm
That would be a very intense treatment to be on both. I am nearing the end of interferon therapy and am looking forward to getting back to normal.
Good luck to your mom – this is a complex diagnosis and the treatments are even more confusing! Luckily this is a time of lots of hope and excitement around melanoma treatments.
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- May 14, 2015 at 9:58 pm
That would be a very intense treatment to be on both. I am nearing the end of interferon therapy and am looking forward to getting back to normal.
Good luck to your mom – this is a complex diagnosis and the treatments are even more confusing! Luckily this is a time of lots of hope and excitement around melanoma treatments.
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- May 16, 2015 at 11:59 am
This is a time for lots of hope and excitement around melanoma treatments and it is time to move on from the old toxic treatments (interferon) and onto the Keytruda and Opdivo. IPI only has small response rate and lots of issues too. You didn't say how old your mom was? or her stage? I agree with Squash, surgery and healing are in her best interest for now.
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- May 16, 2015 at 11:59 am
This is a time for lots of hope and excitement around melanoma treatments and it is time to move on from the old toxic treatments (interferon) and onto the Keytruda and Opdivo. IPI only has small response rate and lots of issues too. You didn't say how old your mom was? or her stage? I agree with Squash, surgery and healing are in her best interest for now.
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- May 16, 2015 at 11:59 am
This is a time for lots of hope and excitement around melanoma treatments and it is time to move on from the old toxic treatments (interferon) and onto the Keytruda and Opdivo. IPI only has small response rate and lots of issues too. You didn't say how old your mom was? or her stage? I agree with Squash, surgery and healing are in her best interest for now.
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- May 18, 2015 at 2:09 am
Well. The first month is pretty intense, after that I was quite sick 3 days a week for the next 11 months. I am lucky that I was in the best shape of my life going into treatments and I have an incredibly supportive partner who was able to take me to appointments and put up with my poor moods! I'm so grateful for the days that I do feel well on treatment. I tried to keep up with exercise as best as possible but I did have to take the year off work. I talk about my experience in a bit more depth on my blog.
Thinking of your mom and wishing her strength!
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- May 18, 2015 at 2:09 am
Well. The first month is pretty intense, after that I was quite sick 3 days a week for the next 11 months. I am lucky that I was in the best shape of my life going into treatments and I have an incredibly supportive partner who was able to take me to appointments and put up with my poor moods! I'm so grateful for the days that I do feel well on treatment. I tried to keep up with exercise as best as possible but I did have to take the year off work. I talk about my experience in a bit more depth on my blog.
Thinking of your mom and wishing her strength!
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- May 18, 2015 at 2:09 am
Well. The first month is pretty intense, after that I was quite sick 3 days a week for the next 11 months. I am lucky that I was in the best shape of my life going into treatments and I have an incredibly supportive partner who was able to take me to appointments and put up with my poor moods! I'm so grateful for the days that I do feel well on treatment. I tried to keep up with exercise as best as possible but I did have to take the year off work. I talk about my experience in a bit more depth on my blog.
Thinking of your mom and wishing her strength!
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- May 18, 2015 at 11:17 pm
I would like to add another opinion about Interferon to the talk. Don't do it ( my experience was terrible on the drug) , there are much better choices out there today, like Ipi or Pd-1 drugs alone or in combination. Take some time and look at the stats on Interferon, they are not very good. Make sure you get a second opinion from a Melanoma specialist before going ahead with a decision. In June, new data will be presented at ASCO about the new drugs. Some of the trials being reported have large # of patients in them. The phase 3 trial that I am part of has around 1000 patients from many countries being treated by Ipi or Nivolumab or both together. I can't stress enough that it is important to educate yourself to the options. Wishing you the best!!! Ed
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- May 18, 2015 at 11:17 pm
I would like to add another opinion about Interferon to the talk. Don't do it ( my experience was terrible on the drug) , there are much better choices out there today, like Ipi or Pd-1 drugs alone or in combination. Take some time and look at the stats on Interferon, they are not very good. Make sure you get a second opinion from a Melanoma specialist before going ahead with a decision. In June, new data will be presented at ASCO about the new drugs. Some of the trials being reported have large # of patients in them. The phase 3 trial that I am part of has around 1000 patients from many countries being treated by Ipi or Nivolumab or both together. I can't stress enough that it is important to educate yourself to the options. Wishing you the best!!! Ed
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- May 18, 2015 at 11:17 pm
I would like to add another opinion about Interferon to the talk. Don't do it ( my experience was terrible on the drug) , there are much better choices out there today, like Ipi or Pd-1 drugs alone or in combination. Take some time and look at the stats on Interferon, they are not very good. Make sure you get a second opinion from a Melanoma specialist before going ahead with a decision. In June, new data will be presented at ASCO about the new drugs. Some of the trials being reported have large # of patients in them. The phase 3 trial that I am part of has around 1000 patients from many countries being treated by Ipi or Nivolumab or both together. I can't stress enough that it is important to educate yourself to the options. Wishing you the best!!! Ed
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- May 20, 2015 at 1:03 am
If I were in your mom's shoes I would look for a different option if one's available. I did the one month high dose and 11 month low dose of interferon and it was a tough year. I also have done Ipi and developed some pretty serious AEs with that treatment. Adding the two together has the potential to be pretty rough.
Do you know what phase the trial is? If it's phase II or III can you find out what the results are for the earlier trial? That is definitely something I would want to know.
It seems like there are a lot of anti-PD1 trials out there right now and I would definitely try to find one of those before enrolling in this trial. Have you sought out any second opinions? I would highly recommend that even if you satisfied with your current oncologist. Best of luck to you and your mom.
Brian
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- May 20, 2015 at 1:03 am
If I were in your mom's shoes I would look for a different option if one's available. I did the one month high dose and 11 month low dose of interferon and it was a tough year. I also have done Ipi and developed some pretty serious AEs with that treatment. Adding the two together has the potential to be pretty rough.
Do you know what phase the trial is? If it's phase II or III can you find out what the results are for the earlier trial? That is definitely something I would want to know.
It seems like there are a lot of anti-PD1 trials out there right now and I would definitely try to find one of those before enrolling in this trial. Have you sought out any second opinions? I would highly recommend that even if you satisfied with your current oncologist. Best of luck to you and your mom.
Brian
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- May 20, 2015 at 1:03 am
If I were in your mom's shoes I would look for a different option if one's available. I did the one month high dose and 11 month low dose of interferon and it was a tough year. I also have done Ipi and developed some pretty serious AEs with that treatment. Adding the two together has the potential to be pretty rough.
Do you know what phase the trial is? If it's phase II or III can you find out what the results are for the earlier trial? That is definitely something I would want to know.
It seems like there are a lot of anti-PD1 trials out there right now and I would definitely try to find one of those before enrolling in this trial. Have you sought out any second opinions? I would highly recommend that even if you satisfied with your current oncologist. Best of luck to you and your mom.
Brian
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