› Forums › General Melanoma Community › anything for brain mets other than whole brain?
- This topic has 12 replies, 3 voices, and was last updated 11 years, 8 months ago by
Jin.
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- September 4, 2012 at 5:56 am
Hello to all you incredible folks. I've been reading this blog since my husband, Chris, was diagnosed with Stage 4 Mel in Jan. 2011. You all have been an inspiration and huge support in our journey. So, I thank you and thank you.
Hello to all you incredible folks. I've been reading this blog since my husband, Chris, was diagnosed with Stage 4 Mel in Jan. 2011. You all have been an inspiration and huge support in our journey. So, I thank you and thank you.
Chris's journey started with a visit to the emergency room followed by a craniotomy for a bleeding brain tumor. This was the first we know he had cancer. He was lucky enough to get on a GSK Braf Inhibitor trial at UCSF in April 2011. Everything looked good for a year and then in April 2012, his scans showed progression in both the brain and the body. He had Gamma Knife to treat the brain mets in May. Also went on Zelboraf and Yervoy In May. Brain MRI in July showed two (out of 14) of the mets treated with gamma had progressed and there were four tiny new mets in his brain. We chose to have no steroids and no treatment of his brain as that would almost certainly require steroids too. We crossed our fingers and hoped the Yervoy would work. Chris is due to have another MRI of his brain this friday. Based on the subcus we can feel, it doesn't appear to be working. We've talked to everyone we can think of but can't any PD-1 or PDL-1 or Adoptive Cell Transfer that will allow him on if he has active brain mets.
Does anyone know of anything? His oncologist is recommending whole brain radiation followed by a gamma knife "boost" in the hope that that will give him 8 wks of brain stability. Everything we've read or hear about whole brain would indicate that whole brain is going to have significant and permanent neurological side effects. Chris is 61, in great health other than the melanoma, and we'd love to have some option other than whole brain radiation.
Any ideas would be much appreciated.
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- September 4, 2012 at 6:58 am
Hi sorry to hear the boat you are in, but stay positive.
I don't think WBR is as bad as people say. Frankly melanoma is your biggest concern, so I would probably listen to your oncologist. My father did WBR for 5 days, and it didn't work but some people do have a measure of success with little side effects. Fatigue tends to be the biggest issue, the treatment knocks you around, but it's doable. I would then follow with gamma as a boost definately. Unfortunately there are not a lot of options trial wise once you have brain mets. Dexamethisone gave me dad real quality of life for 4 months and he never had a headache through out his journey. My dad was 64 and also in good health. Have you tried Temador yet? Ive heard of some on this board having good success as far as keeping things stable.
I't s a hard road, but hang in there.
Nahmi from Melbourne
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- September 4, 2012 at 4:59 pm
Hi Nahmi,
Thanks so much for this. I'm very sorry to hear about your dad. My heart is with you and I really appreciate that you are still on this board.
It's encouraging to hear about the success of Dex with your dad. And we'll definitely check into Temador. I don't know anything about it.
With all best,
Jin
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- September 4, 2012 at 4:59 pm
Hi Nahmi,
Thanks so much for this. I'm very sorry to hear about your dad. My heart is with you and I really appreciate that you are still on this board.
It's encouraging to hear about the success of Dex with your dad. And we'll definitely check into Temador. I don't know anything about it.
With all best,
Jin
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- September 4, 2012 at 4:59 pm
Hi Nahmi,
Thanks so much for this. I'm very sorry to hear about your dad. My heart is with you and I really appreciate that you are still on this board.
It's encouraging to hear about the success of Dex with your dad. And we'll definitely check into Temador. I don't know anything about it.
With all best,
Jin
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- September 4, 2012 at 6:58 am
Hi sorry to hear the boat you are in, but stay positive.
I don't think WBR is as bad as people say. Frankly melanoma is your biggest concern, so I would probably listen to your oncologist. My father did WBR for 5 days, and it didn't work but some people do have a measure of success with little side effects. Fatigue tends to be the biggest issue, the treatment knocks you around, but it's doable. I would then follow with gamma as a boost definately. Unfortunately there are not a lot of options trial wise once you have brain mets. Dexamethisone gave me dad real quality of life for 4 months and he never had a headache through out his journey. My dad was 64 and also in good health. Have you tried Temador yet? Ive heard of some on this board having good success as far as keeping things stable.
I't s a hard road, but hang in there.
Nahmi from Melbourne
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- September 4, 2012 at 6:58 am
Hi sorry to hear the boat you are in, but stay positive.
I don't think WBR is as bad as people say. Frankly melanoma is your biggest concern, so I would probably listen to your oncologist. My father did WBR for 5 days, and it didn't work but some people do have a measure of success with little side effects. Fatigue tends to be the biggest issue, the treatment knocks you around, but it's doable. I would then follow with gamma as a boost definately. Unfortunately there are not a lot of options trial wise once you have brain mets. Dexamethisone gave me dad real quality of life for 4 months and he never had a headache through out his journey. My dad was 64 and also in good health. Have you tried Temador yet? Ive heard of some on this board having good success as far as keeping things stable.
I't s a hard road, but hang in there.
Nahmi from Melbourne
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- September 4, 2012 at 10:31 pm
Jin,
You may want to look into this phase 2 trial. It sounds promising.
Ipilimumab and Fotemustine in Patients With Advanced Melanoma (NIBIT-M1): An Open-Label, Single-Arm Phase 2 Trial
Lancet Oncol. 2012 Aug 12;[Epub Ahead of Print], AM Di Giacomo, PA Ascierto, L Pilla, M Santinami, PF Ferrucci, D Giannarelli, A Marasco, L Rivoltini, E Simeone, SVL Nicoletti, E Fonsatti, D Annesi, P Queirolo, A Testori, R Ridolfi, G Parmiani, M Maio
Abstract
Results of this open-label, single-arm phase II study of the combination of ipilimumab and fotemustine in patients with advanced melanoma showed that the combination is active in patients with metastatic disease, including those with brain metastases.
Abstract
Background: Ipilimumab improves survival of patients with metastatic melanoma, many of whom develop brain metastases. Chemotherapy-induced release of tumour antigens might amplify ipilimumab's antitumour activity. We aimed to investigate the efficacy and safety of ipilimumab plus fotemustine in patients with metastatic melanoma with or without asymptomatic brain metastases.
Methods: In our open-label, single-arm phase 2 trial, we enrolled patients 18 years or older with measurable, locally advanced, unresectable stage III or stage IV melanoma between July 6, 2010, and April 14, 2011. Eligible patients had a life expectancy of 16 weeks or more and an Eastern Cooperative Oncology Group performance status of 1 or less, and could have received a maximum of one previous line of chemotherapy. Participants received induction treatment of 10 mg/kg intravenous ipilimumab every 3 weeks to a total of four doses, and 100 mg/m2 intravenous fotemustine weekly for 3 weeks and then every 3 weeks from week 9 to week 24. Patients with a confirmed clinical response were eligible for maintenance treatment from week 24, with ipilimumab every 12 weeks and fotemustine every 3 weeks. The primary endpoint was the proportion of patients with immune-related disease control as established with immune-related response criteria. Analyses were done per protocol.
Findings: 86 patients were eligible for treatment, of whom 20 had asymptomatic brain metastases at baseline. 40 patients in the study population achieved disease control (46.5%, 95% CI 35.7–57.6), as did ten with brain metastases (50.0%, 27.2–72.8). 47 patients (55%) had grade 3 or 4 treatment-related adverse events, of which the most common was myelotoxicity (thrombocytopenia in 21 [24%] patients and neutropenia in 16 [19%]). The most common grade 3 or 4 immune-related adverse events were hepatic: 21 patients (24%) had grade 3 or 4 increases in concentrations of alanine aminotransferase or aspartate aminotransferase.
Interpretation: The combination of ipilimumab plus fotemustine has clinical activity in patients with metastatic melanoma, including those with brain metastases.
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- September 4, 2012 at 11:59 pm
Hello Brian,
Thanks for this. It looks to me like this trial is over and they will be starting up a Phase III trial which certainly could be of interest. As far as I could tell they only accepted "asymptomatic" brain metastases in the Phase ii which would exclude Chris. He still has some brain mets that are growing. Maybe in the Phase iii trial they'll open up a brain mets arm. That would be incredible.
Thanks again,
Jin
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- September 4, 2012 at 11:59 pm
Hello Brian,
Thanks for this. It looks to me like this trial is over and they will be starting up a Phase III trial which certainly could be of interest. As far as I could tell they only accepted "asymptomatic" brain metastases in the Phase ii which would exclude Chris. He still has some brain mets that are growing. Maybe in the Phase iii trial they'll open up a brain mets arm. That would be incredible.
Thanks again,
Jin
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- September 4, 2012 at 11:59 pm
Hello Brian,
Thanks for this. It looks to me like this trial is over and they will be starting up a Phase III trial which certainly could be of interest. As far as I could tell they only accepted "asymptomatic" brain metastases in the Phase ii which would exclude Chris. He still has some brain mets that are growing. Maybe in the Phase iii trial they'll open up a brain mets arm. That would be incredible.
Thanks again,
Jin
-
- September 4, 2012 at 10:31 pm
Jin,
You may want to look into this phase 2 trial. It sounds promising.
Ipilimumab and Fotemustine in Patients With Advanced Melanoma (NIBIT-M1): An Open-Label, Single-Arm Phase 2 Trial
Lancet Oncol. 2012 Aug 12;[Epub Ahead of Print], AM Di Giacomo, PA Ascierto, L Pilla, M Santinami, PF Ferrucci, D Giannarelli, A Marasco, L Rivoltini, E Simeone, SVL Nicoletti, E Fonsatti, D Annesi, P Queirolo, A Testori, R Ridolfi, G Parmiani, M Maio
Abstract
Results of this open-label, single-arm phase II study of the combination of ipilimumab and fotemustine in patients with advanced melanoma showed that the combination is active in patients with metastatic disease, including those with brain metastases.
Abstract
Background: Ipilimumab improves survival of patients with metastatic melanoma, many of whom develop brain metastases. Chemotherapy-induced release of tumour antigens might amplify ipilimumab's antitumour activity. We aimed to investigate the efficacy and safety of ipilimumab plus fotemustine in patients with metastatic melanoma with or without asymptomatic brain metastases.
Methods: In our open-label, single-arm phase 2 trial, we enrolled patients 18 years or older with measurable, locally advanced, unresectable stage III or stage IV melanoma between July 6, 2010, and April 14, 2011. Eligible patients had a life expectancy of 16 weeks or more and an Eastern Cooperative Oncology Group performance status of 1 or less, and could have received a maximum of one previous line of chemotherapy. Participants received induction treatment of 10 mg/kg intravenous ipilimumab every 3 weeks to a total of four doses, and 100 mg/m2 intravenous fotemustine weekly for 3 weeks and then every 3 weeks from week 9 to week 24. Patients with a confirmed clinical response were eligible for maintenance treatment from week 24, with ipilimumab every 12 weeks and fotemustine every 3 weeks. The primary endpoint was the proportion of patients with immune-related disease control as established with immune-related response criteria. Analyses were done per protocol.
Findings: 86 patients were eligible for treatment, of whom 20 had asymptomatic brain metastases at baseline. 40 patients in the study population achieved disease control (46.5%, 95% CI 35.7–57.6), as did ten with brain metastases (50.0%, 27.2–72.8). 47 patients (55%) had grade 3 or 4 treatment-related adverse events, of which the most common was myelotoxicity (thrombocytopenia in 21 [24%] patients and neutropenia in 16 [19%]). The most common grade 3 or 4 immune-related adverse events were hepatic: 21 patients (24%) had grade 3 or 4 increases in concentrations of alanine aminotransferase or aspartate aminotransferase.
Interpretation: The combination of ipilimumab plus fotemustine has clinical activity in patients with metastatic melanoma, including those with brain metastases.
-
- September 4, 2012 at 10:31 pm
Jin,
You may want to look into this phase 2 trial. It sounds promising.
Ipilimumab and Fotemustine in Patients With Advanced Melanoma (NIBIT-M1): An Open-Label, Single-Arm Phase 2 Trial
Lancet Oncol. 2012 Aug 12;[Epub Ahead of Print], AM Di Giacomo, PA Ascierto, L Pilla, M Santinami, PF Ferrucci, D Giannarelli, A Marasco, L Rivoltini, E Simeone, SVL Nicoletti, E Fonsatti, D Annesi, P Queirolo, A Testori, R Ridolfi, G Parmiani, M Maio
Abstract
Results of this open-label, single-arm phase II study of the combination of ipilimumab and fotemustine in patients with advanced melanoma showed that the combination is active in patients with metastatic disease, including those with brain metastases.
Abstract
Background: Ipilimumab improves survival of patients with metastatic melanoma, many of whom develop brain metastases. Chemotherapy-induced release of tumour antigens might amplify ipilimumab's antitumour activity. We aimed to investigate the efficacy and safety of ipilimumab plus fotemustine in patients with metastatic melanoma with or without asymptomatic brain metastases.
Methods: In our open-label, single-arm phase 2 trial, we enrolled patients 18 years or older with measurable, locally advanced, unresectable stage III or stage IV melanoma between July 6, 2010, and April 14, 2011. Eligible patients had a life expectancy of 16 weeks or more and an Eastern Cooperative Oncology Group performance status of 1 or less, and could have received a maximum of one previous line of chemotherapy. Participants received induction treatment of 10 mg/kg intravenous ipilimumab every 3 weeks to a total of four doses, and 100 mg/m2 intravenous fotemustine weekly for 3 weeks and then every 3 weeks from week 9 to week 24. Patients with a confirmed clinical response were eligible for maintenance treatment from week 24, with ipilimumab every 12 weeks and fotemustine every 3 weeks. The primary endpoint was the proportion of patients with immune-related disease control as established with immune-related response criteria. Analyses were done per protocol.
Findings: 86 patients were eligible for treatment, of whom 20 had asymptomatic brain metastases at baseline. 40 patients in the study population achieved disease control (46.5%, 95% CI 35.7–57.6), as did ten with brain metastases (50.0%, 27.2–72.8). 47 patients (55%) had grade 3 or 4 treatment-related adverse events, of which the most common was myelotoxicity (thrombocytopenia in 21 [24%] patients and neutropenia in 16 [19%]). The most common grade 3 or 4 immune-related adverse events were hepatic: 21 patients (24%) had grade 3 or 4 increases in concentrations of alanine aminotransferase or aspartate aminotransferase.
Interpretation: The combination of ipilimumab plus fotemustine has clinical activity in patients with metastatic melanoma, including those with brain metastases.
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