› Forums › General Melanoma Community › Washout period for TIL?
- This topic has 48 replies, 7 voices, and was last updated 9 years, 6 months ago by
RJoeyB.
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- November 7, 2014 at 6:00 pm
Just got a call from June Kryk. She's saying I need a 4 week washout period before I first see them. Does that sound right? The paper work form said to stay on my current treatment until I get accepted into a trial. I would have thought the 4 week washout period would be after the first visit not before. Am I missing something?
Basically otherwise she explained the process like I expected. They get all the scans and stuff they need. I go for the first visit where they remove one tumor. They grow the cells and I go home. Once the cells grow which she said varies from 3 to 6 weeks. Then I go back for a second visit for 3 weeks. Week 1 is the chemo to wipe out my white blood cells. Week 2 is getting the new cells and 3 days of IL-2. The rest is recovery. The 3rd visit is 4 weeks later for scans.
Oh for those who know her June Kryk is retiring and the lady who called me yesterday Jessica Yingling is her replacement.
Artie
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- November 7, 2014 at 6:29 pm
Artie,
I didnt have a washout, but TIL was the first thing I did — it was 2010, Yervoy and the BRAF/MEKs weren' tapproved yet and the anti-PD-1's were even further away. I just did a quick look at Dr. Rosenberg's current trials, and one of the first TILtrials I see here:
http://clinicaltrials.gov/ct2/show/study/NCT01993719
In eligibility criteria 13 and 14 read:
13. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). Patients must have progressive disease after prior treatment. Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.14. Six weeks must have elapsed from the time of any antibody therapy that could affect an anti cancer immune response, including anti-CTLA4 antibody therapy, so at the time the patient receives the preparative regimen to allow antibody levels to decline. Note: Patients who have previously received ipilimumab and have documented GI toxicity must have a colonoscopy with normal colonic biopsies.To me, it reads like they should be able to evaluate you now. It doesn't make sense (to me) to require you to stop your PD-1 for four weeks until they've accepted you into the trial. Then they could have you start the washout. (By the way, (14) mentions anti-CTLA4 and ipilimumab, but would also include PD-1.) I'd ask for clarification on this and see if you can be evaluated before stopping the PD-1. I'd also want to know that they're confident that they have resectable tumor to harvest before stopping.Otherwise, yes, the schedule is pretty standard for their TIL protocols, even with the small variations they have from trial to trial. But both the 4- and 6- week "washouts" they list count back from when you start the chemo ("the preparatory regimen"), not when they harvest the tumor.Joe -
- November 7, 2014 at 6:29 pm
Artie,
I didnt have a washout, but TIL was the first thing I did — it was 2010, Yervoy and the BRAF/MEKs weren' tapproved yet and the anti-PD-1's were even further away. I just did a quick look at Dr. Rosenberg's current trials, and one of the first TILtrials I see here:
http://clinicaltrials.gov/ct2/show/study/NCT01993719
In eligibility criteria 13 and 14 read:
13. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). Patients must have progressive disease after prior treatment. Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.14. Six weeks must have elapsed from the time of any antibody therapy that could affect an anti cancer immune response, including anti-CTLA4 antibody therapy, so at the time the patient receives the preparative regimen to allow antibody levels to decline. Note: Patients who have previously received ipilimumab and have documented GI toxicity must have a colonoscopy with normal colonic biopsies.To me, it reads like they should be able to evaluate you now. It doesn't make sense (to me) to require you to stop your PD-1 for four weeks until they've accepted you into the trial. Then they could have you start the washout. (By the way, (14) mentions anti-CTLA4 and ipilimumab, but would also include PD-1.) I'd ask for clarification on this and see if you can be evaluated before stopping the PD-1. I'd also want to know that they're confident that they have resectable tumor to harvest before stopping.Otherwise, yes, the schedule is pretty standard for their TIL protocols, even with the small variations they have from trial to trial. But both the 4- and 6- week "washouts" they list count back from when you start the chemo ("the preparatory regimen"), not when they harvest the tumor.Joe-
- November 7, 2014 at 8:39 pm
Good. Thanks Joe. That is exactly the way I understood it too. So Nov 4 was lastest pd1. Next would be Nov 25. They are thinking to see me first week of Dec so like Dec 1 let's say is the harvest. Assume 4 weeks to grow the cells (although she says it varies from 3 to 6 weeks) so preparatory regimen on Dec 29. So yeah walking that back makes sense not to get the Nov 25 dose. All depends on when they really want to start, how long the cells take and stuff. Kind of scary not getting my pd1 for so long but after the harvest if they take the huge tumor in my shoulder like my doc here thinks I should be pretty good tumor wise. The other 30 or so tumors aren't anywhere near as big as it is. Plus pd1 might already keep working for me even without it at least a little. I'll play it by ear for now. Good to know. Thanks.
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- November 7, 2014 at 9:34 pm
Hi Artie!
My situation was different because i hadn't had any treatment for about three months. I was all set to do IL2 at UVA when the opportunity to do the TIL came up. I didn't have a tumor that they could use….I thought they could use a tumor that was on my shoulder blade, but it was wrapped around my ribs. They said it would be a very major surgery. The other tumors were too small. They took a core biopsy of the shoulder blade tumor and tried to harvest my cells but they didn't grow. I was bummed! Then they emailed me about the MAGE TCR trial. The protocol was very similar to the TIL. I hope it works out for you!!!! Although the MAGE TCR didn't work for me, I have no regrets. I'm doing well with Keytruda. My LDH went from 534 to 141 but if that trend stops and I start to have progression, I'll do the TIL too…assuming that I have a tumor that they can use. Good luck, Artie!!! Keep us posted.
Terrie
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- November 7, 2014 at 9:34 pm
Hi Artie!
My situation was different because i hadn't had any treatment for about three months. I was all set to do IL2 at UVA when the opportunity to do the TIL came up. I didn't have a tumor that they could use….I thought they could use a tumor that was on my shoulder blade, but it was wrapped around my ribs. They said it would be a very major surgery. The other tumors were too small. They took a core biopsy of the shoulder blade tumor and tried to harvest my cells but they didn't grow. I was bummed! Then they emailed me about the MAGE TCR trial. The protocol was very similar to the TIL. I hope it works out for you!!!! Although the MAGE TCR didn't work for me, I have no regrets. I'm doing well with Keytruda. My LDH went from 534 to 141 but if that trend stops and I start to have progression, I'll do the TIL too…assuming that I have a tumor that they can use. Good luck, Artie!!! Keep us posted.
Terrie
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- November 7, 2014 at 9:34 pm
Hi Artie!
My situation was different because i hadn't had any treatment for about three months. I was all set to do IL2 at UVA when the opportunity to do the TIL came up. I didn't have a tumor that they could use….I thought they could use a tumor that was on my shoulder blade, but it was wrapped around my ribs. They said it would be a very major surgery. The other tumors were too small. They took a core biopsy of the shoulder blade tumor and tried to harvest my cells but they didn't grow. I was bummed! Then they emailed me about the MAGE TCR trial. The protocol was very similar to the TIL. I hope it works out for you!!!! Although the MAGE TCR didn't work for me, I have no regrets. I'm doing well with Keytruda. My LDH went from 534 to 141 but if that trend stops and I start to have progression, I'll do the TIL too…assuming that I have a tumor that they can use. Good luck, Artie!!! Keep us posted.
Terrie
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- November 8, 2014 at 1:45 am
So just to clarify for you, they're going to evaluate you for one of the TIL trials (or possibly something else, if appropriate) in early December, and if they accept you, they'll go ahead and do the tumor harvest during that same trip? I guess that makes sense and saves you a trip, plus if there's an issue with getting into the trial, you'd only miss a single dose of PD-1. I live closer to Bethesda, about 2.5 hours from Philly, so we were back and forth a lot (12 times in less than a year, but that was for TIL, IL-2, scans, 2 surgeries, etc.), and my first visit was the evaluation, we came home not knowing if I was accepted into any trial, let alone which one. A few days later they told me which trial they were recommending and a few days after that, I was "randomized" into my arm of the trial, and back in Bethesda a couple of days later for the tumor harvest — perhaps a week or so from evaluation to harvest.
Refresh my memory, from where are you traveling Artie? And as far as the shoulder, it sounds as if your doctor thinks it is resectable? For some reason, I thought it was a bone met you had in your shoulder — is it in the soft tissue?
After the harvest, it got complicated for me, similar to what happened with Terrie. My cells from my original back lesion didn't grow fast enough (they knew within a week of the harvest), so I switched to the IL-2 arm. I did two courses of IL-2, then my cells started growing, but by that time I had other complications, including a shoulder bone met that was a fracture risk and a small bowel met that was a risk during chemo. So I had a radical resection of the shoulder met and replaced with a 10" titanium rod and later had the small bowel met harvested and they grew a second batch of cells from it — they grew like wildfire in three weeks and I was quickly back to complete the TIL after that… but 6 months after my original harvest surgery.
Joe
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- November 8, 2014 at 1:45 am
So just to clarify for you, they're going to evaluate you for one of the TIL trials (or possibly something else, if appropriate) in early December, and if they accept you, they'll go ahead and do the tumor harvest during that same trip? I guess that makes sense and saves you a trip, plus if there's an issue with getting into the trial, you'd only miss a single dose of PD-1. I live closer to Bethesda, about 2.5 hours from Philly, so we were back and forth a lot (12 times in less than a year, but that was for TIL, IL-2, scans, 2 surgeries, etc.), and my first visit was the evaluation, we came home not knowing if I was accepted into any trial, let alone which one. A few days later they told me which trial they were recommending and a few days after that, I was "randomized" into my arm of the trial, and back in Bethesda a couple of days later for the tumor harvest — perhaps a week or so from evaluation to harvest.
Refresh my memory, from where are you traveling Artie? And as far as the shoulder, it sounds as if your doctor thinks it is resectable? For some reason, I thought it was a bone met you had in your shoulder — is it in the soft tissue?
After the harvest, it got complicated for me, similar to what happened with Terrie. My cells from my original back lesion didn't grow fast enough (they knew within a week of the harvest), so I switched to the IL-2 arm. I did two courses of IL-2, then my cells started growing, but by that time I had other complications, including a shoulder bone met that was a fracture risk and a small bowel met that was a risk during chemo. So I had a radical resection of the shoulder met and replaced with a 10" titanium rod and later had the small bowel met harvested and they grew a second batch of cells from it — they grew like wildfire in three weeks and I was quickly back to complete the TIL after that… but 6 months after my original harvest surgery.
Joe
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- November 8, 2014 at 1:45 am
So just to clarify for you, they're going to evaluate you for one of the TIL trials (or possibly something else, if appropriate) in early December, and if they accept you, they'll go ahead and do the tumor harvest during that same trip? I guess that makes sense and saves you a trip, plus if there's an issue with getting into the trial, you'd only miss a single dose of PD-1. I live closer to Bethesda, about 2.5 hours from Philly, so we were back and forth a lot (12 times in less than a year, but that was for TIL, IL-2, scans, 2 surgeries, etc.), and my first visit was the evaluation, we came home not knowing if I was accepted into any trial, let alone which one. A few days later they told me which trial they were recommending and a few days after that, I was "randomized" into my arm of the trial, and back in Bethesda a couple of days later for the tumor harvest — perhaps a week or so from evaluation to harvest.
Refresh my memory, from where are you traveling Artie? And as far as the shoulder, it sounds as if your doctor thinks it is resectable? For some reason, I thought it was a bone met you had in your shoulder — is it in the soft tissue?
After the harvest, it got complicated for me, similar to what happened with Terrie. My cells from my original back lesion didn't grow fast enough (they knew within a week of the harvest), so I switched to the IL-2 arm. I did two courses of IL-2, then my cells started growing, but by that time I had other complications, including a shoulder bone met that was a fracture risk and a small bowel met that was a risk during chemo. So I had a radical resection of the shoulder met and replaced with a 10" titanium rod and later had the small bowel met harvested and they grew a second batch of cells from it — they grew like wildfire in three weeks and I was quickly back to complete the TIL after that… but 6 months after my original harvest surgery.
Joe
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- November 8, 2014 at 8:11 pm
I'll be coming from Saint Louis. So about 800 miles. Due to the weather and knowing I will need to recover from surgery we plan to stay while they grow the cells.
Yeah the one in my shoulder started in my left scapula bone. Since then it is huge with soft tissue involvement. I basically look like the hunchback from notre dame. I can basically take my hand and it's like feeling a soft grape fruit size mass. Plus according to the scans there are other spreads of that tumor here and there granted the center they say is nectrotic. I also have a smaller one that started in my left collar bone and spread to soft tissue about the size of a small child's fist. So yeah they got plenty of soft tissue to work with. They won't be able to get the entire tumor but certainly a huge mass.
Artie
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- November 8, 2014 at 8:11 pm
I'll be coming from Saint Louis. So about 800 miles. Due to the weather and knowing I will need to recover from surgery we plan to stay while they grow the cells.
Yeah the one in my shoulder started in my left scapula bone. Since then it is huge with soft tissue involvement. I basically look like the hunchback from notre dame. I can basically take my hand and it's like feeling a soft grape fruit size mass. Plus according to the scans there are other spreads of that tumor here and there granted the center they say is nectrotic. I also have a smaller one that started in my left collar bone and spread to soft tissue about the size of a small child's fist. So yeah they got plenty of soft tissue to work with. They won't be able to get the entire tumor but certainly a huge mass.
Artie
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- November 8, 2014 at 8:11 pm
I'll be coming from Saint Louis. So about 800 miles. Due to the weather and knowing I will need to recover from surgery we plan to stay while they grow the cells.
Yeah the one in my shoulder started in my left scapula bone. Since then it is huge with soft tissue involvement. I basically look like the hunchback from notre dame. I can basically take my hand and it's like feeling a soft grape fruit size mass. Plus according to the scans there are other spreads of that tumor here and there granted the center they say is nectrotic. I also have a smaller one that started in my left collar bone and spread to soft tissue about the size of a small child's fist. So yeah they got plenty of soft tissue to work with. They won't be able to get the entire tumor but certainly a huge mass.
Artie
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- November 10, 2014 at 6:33 pm
Hey Artie,
On the practical front, I'd suggest starting to look at lodging options for Bethesda now, if you haven't already. Other than my time at NIH, we haven't had to travel for appointments, scans, or treatment, so I don't have a good comparison, but lodging in and around Bethesda was often close to capacity and expensive. I mentioned somewhere here (this post or another), that over about a year, we made 12 overnight trips (driving) between Philly and Bethesda, including the 2 one week inpatient stays for IL-2, another one week stay for small bowel tumor resection, and the big three week "spa stay" (as we call it) for the TIL preparation, infusion, and IL-2. But given the proximity to DC, and the visitors to NIH alone, there were times things filled quickly.
If you'll be an inpatient for a week or longer, there is a facility on the NIH campus called the Safra Lodge where caregivers can stay at no cost. Availability isn't guaranteed and there's a priority list — they should assign you a social worker during your intake visit and the request for the lodge should come from them (it actually needs to come from the clinical trial nurse, but the social worker can coordinate it). It's a nice facility right next to the Clinical Center, two minutes walking distance. My wife was able to stay there during all of my first IL-2 round, most of the second, and all of my TIL treatment. There were some nights during IL-2 that she stayed with me in the hospital, but it was great having the lodge the rest of the time for her to have a place so close where she could get a good night's sleep, shower, or even an afternoon nap. There were a couple of nights during the preparatory chemo that I was able to stay at the lodge instead of in the hospital, too. One less night trying to sleep in any hospital is a good thing.
Be prepared for heavy security, especially during your first visit — heavier than any airport or other security than I've been through. But if you're accepted into the trial, make sure you and anyone traveling with you gets a long-term visitor pass (it's good for a year), that will make getting into the fortification a lot easier.
Finally, other than the intake visit, once you're participating in a trial, they reimburse travel expenses for the patient. In my case, it was driving mileage, but it adds up. I also think there is a lodging per diem for the patient, but only if they are requiring you to stay local but not as an inpatient, which we never encountered.
Joe
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- November 10, 2014 at 6:33 pm
Hey Artie,
On the practical front, I'd suggest starting to look at lodging options for Bethesda now, if you haven't already. Other than my time at NIH, we haven't had to travel for appointments, scans, or treatment, so I don't have a good comparison, but lodging in and around Bethesda was often close to capacity and expensive. I mentioned somewhere here (this post or another), that over about a year, we made 12 overnight trips (driving) between Philly and Bethesda, including the 2 one week inpatient stays for IL-2, another one week stay for small bowel tumor resection, and the big three week "spa stay" (as we call it) for the TIL preparation, infusion, and IL-2. But given the proximity to DC, and the visitors to NIH alone, there were times things filled quickly.
If you'll be an inpatient for a week or longer, there is a facility on the NIH campus called the Safra Lodge where caregivers can stay at no cost. Availability isn't guaranteed and there's a priority list — they should assign you a social worker during your intake visit and the request for the lodge should come from them (it actually needs to come from the clinical trial nurse, but the social worker can coordinate it). It's a nice facility right next to the Clinical Center, two minutes walking distance. My wife was able to stay there during all of my first IL-2 round, most of the second, and all of my TIL treatment. There were some nights during IL-2 that she stayed with me in the hospital, but it was great having the lodge the rest of the time for her to have a place so close where she could get a good night's sleep, shower, or even an afternoon nap. There were a couple of nights during the preparatory chemo that I was able to stay at the lodge instead of in the hospital, too. One less night trying to sleep in any hospital is a good thing.
Be prepared for heavy security, especially during your first visit — heavier than any airport or other security than I've been through. But if you're accepted into the trial, make sure you and anyone traveling with you gets a long-term visitor pass (it's good for a year), that will make getting into the fortification a lot easier.
Finally, other than the intake visit, once you're participating in a trial, they reimburse travel expenses for the patient. In my case, it was driving mileage, but it adds up. I also think there is a lodging per diem for the patient, but only if they are requiring you to stay local but not as an inpatient, which we never encountered.
Joe
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- November 10, 2014 at 6:33 pm
Hey Artie,
On the practical front, I'd suggest starting to look at lodging options for Bethesda now, if you haven't already. Other than my time at NIH, we haven't had to travel for appointments, scans, or treatment, so I don't have a good comparison, but lodging in and around Bethesda was often close to capacity and expensive. I mentioned somewhere here (this post or another), that over about a year, we made 12 overnight trips (driving) between Philly and Bethesda, including the 2 one week inpatient stays for IL-2, another one week stay for small bowel tumor resection, and the big three week "spa stay" (as we call it) for the TIL preparation, infusion, and IL-2. But given the proximity to DC, and the visitors to NIH alone, there were times things filled quickly.
If you'll be an inpatient for a week or longer, there is a facility on the NIH campus called the Safra Lodge where caregivers can stay at no cost. Availability isn't guaranteed and there's a priority list — they should assign you a social worker during your intake visit and the request for the lodge should come from them (it actually needs to come from the clinical trial nurse, but the social worker can coordinate it). It's a nice facility right next to the Clinical Center, two minutes walking distance. My wife was able to stay there during all of my first IL-2 round, most of the second, and all of my TIL treatment. There were some nights during IL-2 that she stayed with me in the hospital, but it was great having the lodge the rest of the time for her to have a place so close where she could get a good night's sleep, shower, or even an afternoon nap. There were a couple of nights during the preparatory chemo that I was able to stay at the lodge instead of in the hospital, too. One less night trying to sleep in any hospital is a good thing.
Be prepared for heavy security, especially during your first visit — heavier than any airport or other security than I've been through. But if you're accepted into the trial, make sure you and anyone traveling with you gets a long-term visitor pass (it's good for a year), that will make getting into the fortification a lot easier.
Finally, other than the intake visit, once you're participating in a trial, they reimburse travel expenses for the patient. In my case, it was driving mileage, but it adds up. I also think there is a lodging per diem for the patient, but only if they are requiring you to stay local but not as an inpatient, which we never encountered.
Joe
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- November 7, 2014 at 8:39 pm
Good. Thanks Joe. That is exactly the way I understood it too. So Nov 4 was lastest pd1. Next would be Nov 25. They are thinking to see me first week of Dec so like Dec 1 let's say is the harvest. Assume 4 weeks to grow the cells (although she says it varies from 3 to 6 weeks) so preparatory regimen on Dec 29. So yeah walking that back makes sense not to get the Nov 25 dose. All depends on when they really want to start, how long the cells take and stuff. Kind of scary not getting my pd1 for so long but after the harvest if they take the huge tumor in my shoulder like my doc here thinks I should be pretty good tumor wise. The other 30 or so tumors aren't anywhere near as big as it is. Plus pd1 might already keep working for me even without it at least a little. I'll play it by ear for now. Good to know. Thanks.
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- November 7, 2014 at 8:39 pm
Good. Thanks Joe. That is exactly the way I understood it too. So Nov 4 was lastest pd1. Next would be Nov 25. They are thinking to see me first week of Dec so like Dec 1 let's say is the harvest. Assume 4 weeks to grow the cells (although she says it varies from 3 to 6 weeks) so preparatory regimen on Dec 29. So yeah walking that back makes sense not to get the Nov 25 dose. All depends on when they really want to start, how long the cells take and stuff. Kind of scary not getting my pd1 for so long but after the harvest if they take the huge tumor in my shoulder like my doc here thinks I should be pretty good tumor wise. The other 30 or so tumors aren't anywhere near as big as it is. Plus pd1 might already keep working for me even without it at least a little. I'll play it by ear for now. Good to know. Thanks.
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- November 7, 2014 at 6:29 pm
Artie,
I didnt have a washout, but TIL was the first thing I did — it was 2010, Yervoy and the BRAF/MEKs weren' tapproved yet and the anti-PD-1's were even further away. I just did a quick look at Dr. Rosenberg's current trials, and one of the first TILtrials I see here:
http://clinicaltrials.gov/ct2/show/study/NCT01993719
In eligibility criteria 13 and 14 read:
13. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). Patients must have progressive disease after prior treatment. Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.14. Six weeks must have elapsed from the time of any antibody therapy that could affect an anti cancer immune response, including anti-CTLA4 antibody therapy, so at the time the patient receives the preparative regimen to allow antibody levels to decline. Note: Patients who have previously received ipilimumab and have documented GI toxicity must have a colonoscopy with normal colonic biopsies.To me, it reads like they should be able to evaluate you now. It doesn't make sense (to me) to require you to stop your PD-1 for four weeks until they've accepted you into the trial. Then they could have you start the washout. (By the way, (14) mentions anti-CTLA4 and ipilimumab, but would also include PD-1.) I'd ask for clarification on this and see if you can be evaluated before stopping the PD-1. I'd also want to know that they're confident that they have resectable tumor to harvest before stopping.Otherwise, yes, the schedule is pretty standard for their TIL protocols, even with the small variations they have from trial to trial. But both the 4- and 6- week "washouts" they list count back from when you start the chemo ("the preparatory regimen"), not when they harvest the tumor.Joe -
- November 8, 2014 at 3:03 am
Hi Artie,
I know it's difficult to correspond with the NIH. I'm currently in a waiting period with the TIL trial but they sent me home to get chemo/radiation. About two years ago I was trying to get into the TIL program but it was so difficult to correspond with them I ended up going with a different option. They had all my notes, scans, etc and each time I called them they said they would call back, no response. First thing I would definitely reach out to your current oncologist and ask them to contact a doctor at the NIH or Dr. Rosenberg directly. If your oncologist will call on your behalf that will help.
As far as washouts, I know my last treatment of PD1 was August 19th and I did get accepted into a trial in August. I then had to go for the surgery and then while you wait to see if your cells grow, you are then washing out. I believe my surgery was September 9th. So I don't think you necessarily have to have a washout before getting accepted. But you do need a somewhat of washout to remove one of your tumors for the TIL. I remember the doctors wouldn't take my tumor when I was accepted because I had to come back two weeks later. I hope that makes sense at all.
Good luck,
Shane
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- November 8, 2014 at 3:03 am
Hi Artie,
I know it's difficult to correspond with the NIH. I'm currently in a waiting period with the TIL trial but they sent me home to get chemo/radiation. About two years ago I was trying to get into the TIL program but it was so difficult to correspond with them I ended up going with a different option. They had all my notes, scans, etc and each time I called them they said they would call back, no response. First thing I would definitely reach out to your current oncologist and ask them to contact a doctor at the NIH or Dr. Rosenberg directly. If your oncologist will call on your behalf that will help.
As far as washouts, I know my last treatment of PD1 was August 19th and I did get accepted into a trial in August. I then had to go for the surgery and then while you wait to see if your cells grow, you are then washing out. I believe my surgery was September 9th. So I don't think you necessarily have to have a washout before getting accepted. But you do need a somewhat of washout to remove one of your tumors for the TIL. I remember the doctors wouldn't take my tumor when I was accepted because I had to come back two weeks later. I hope that makes sense at all.
Good luck,
Shane
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- November 8, 2014 at 3:03 am
Hi Artie,
I know it's difficult to correspond with the NIH. I'm currently in a waiting period with the TIL trial but they sent me home to get chemo/radiation. About two years ago I was trying to get into the TIL program but it was so difficult to correspond with them I ended up going with a different option. They had all my notes, scans, etc and each time I called them they said they would call back, no response. First thing I would definitely reach out to your current oncologist and ask them to contact a doctor at the NIH or Dr. Rosenberg directly. If your oncologist will call on your behalf that will help.
As far as washouts, I know my last treatment of PD1 was August 19th and I did get accepted into a trial in August. I then had to go for the surgery and then while you wait to see if your cells grow, you are then washing out. I believe my surgery was September 9th. So I don't think you necessarily have to have a washout before getting accepted. But you do need a somewhat of washout to remove one of your tumors for the TIL. I remember the doctors wouldn't take my tumor when I was accepted because I had to come back two weeks later. I hope that makes sense at all.
Good luck,
Shane
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- November 8, 2014 at 8:17 pm
Ok. Thanks. That must be what she was talking about is the washout before removing the tumor for the TIL.
So far I've been quite happy with them. They've called a few times and emailed a few times. Also I know from my local doc they are supposed to have everything shipped to nih monday. So yeah. I think everything is going smoothly. Also it seems to help that there are 2 of us my local doc is sending and since I'm the second one they already know what to do so it's going smooth. I don't know who the other person is but maybe we will meet.
Artie
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- November 8, 2014 at 8:17 pm
Ok. Thanks. That must be what she was talking about is the washout before removing the tumor for the TIL.
So far I've been quite happy with them. They've called a few times and emailed a few times. Also I know from my local doc they are supposed to have everything shipped to nih monday. So yeah. I think everything is going smoothly. Also it seems to help that there are 2 of us my local doc is sending and since I'm the second one they already know what to do so it's going smooth. I don't know who the other person is but maybe we will meet.
Artie
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- November 8, 2014 at 8:17 pm
Ok. Thanks. That must be what she was talking about is the washout before removing the tumor for the TIL.
So far I've been quite happy with them. They've called a few times and emailed a few times. Also I know from my local doc they are supposed to have everything shipped to nih monday. So yeah. I think everything is going smoothly. Also it seems to help that there are 2 of us my local doc is sending and since I'm the second one they already know what to do so it's going smooth. I don't know who the other person is but maybe we will meet.
Artie
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- November 8, 2014 at 4:54 am
Artie, I also looked at TIL at the NIH. I was initially accepted, but then ultimately rejected because of the then aggressive nature of my tumor burden. I keep an eye on TIL posts on this forum and MIF. My takeaway is that if I need to look at TIL again, while NIH would be ideal (particularly because of the proximity of the location for me)–MDA (Dr. Hwu) seems to have less stringent requirements. You might consider reaching out to them.
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- November 8, 2014 at 4:54 am
Artie, I also looked at TIL at the NIH. I was initially accepted, but then ultimately rejected because of the then aggressive nature of my tumor burden. I keep an eye on TIL posts on this forum and MIF. My takeaway is that if I need to look at TIL again, while NIH would be ideal (particularly because of the proximity of the location for me)–MDA (Dr. Hwu) seems to have less stringent requirements. You might consider reaching out to them.
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- November 8, 2014 at 4:54 am
Artie, I also looked at TIL at the NIH. I was initially accepted, but then ultimately rejected because of the then aggressive nature of my tumor burden. I keep an eye on TIL posts on this forum and MIF. My takeaway is that if I need to look at TIL again, while NIH would be ideal (particularly because of the proximity of the location for me)–MDA (Dr. Hwu) seems to have less stringent requirements. You might consider reaching out to them.
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- November 8, 2014 at 6:40 am
That's a good point Mat. I don't know many details, but MDA also has a "TIL banking" program that allows patients to have a tumor harvested and then frozen, banked for use later if the patient decides to proceed. I don't know the specific circumstances where they allow it, or where in the process the harvested tumor is frozen (following resection, after the TILs are selected, or after they are fully expanded/grown). But I know of several folks who have had this done and banked their tumor/TILs for future possible use.
The basic TIL protocol is the same as at NIH's. I think NIH may have some new variations they're trying with both the preparatory regimens (adding total body irradiation and varying the amount of chemotherapy) and the post-infusion IL-2 (trying to reduce or eliminate it), which may provide more options for patients to meet some of the eligibility criteria. Also, Moffitt (in Tampa) has a trial (or trials) with Lion Biotechnologies, who have licensed the NIH processes in hopes of turning it into a product. I think their current trials are combinations with ipi and another with nivo, so that could be a problem if you've already had either. However, to Mat's point, it's certainly worth a call to MDA and perhaps also Moffitt, as it may give you more options and chances to meet the trial criteria.
Joe
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- November 8, 2014 at 6:40 am
That's a good point Mat. I don't know many details, but MDA also has a "TIL banking" program that allows patients to have a tumor harvested and then frozen, banked for use later if the patient decides to proceed. I don't know the specific circumstances where they allow it, or where in the process the harvested tumor is frozen (following resection, after the TILs are selected, or after they are fully expanded/grown). But I know of several folks who have had this done and banked their tumor/TILs for future possible use.
The basic TIL protocol is the same as at NIH's. I think NIH may have some new variations they're trying with both the preparatory regimens (adding total body irradiation and varying the amount of chemotherapy) and the post-infusion IL-2 (trying to reduce or eliminate it), which may provide more options for patients to meet some of the eligibility criteria. Also, Moffitt (in Tampa) has a trial (or trials) with Lion Biotechnologies, who have licensed the NIH processes in hopes of turning it into a product. I think their current trials are combinations with ipi and another with nivo, so that could be a problem if you've already had either. However, to Mat's point, it's certainly worth a call to MDA and perhaps also Moffitt, as it may give you more options and chances to meet the trial criteria.
Joe
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- November 8, 2014 at 6:40 am
That's a good point Mat. I don't know many details, but MDA also has a "TIL banking" program that allows patients to have a tumor harvested and then frozen, banked for use later if the patient decides to proceed. I don't know the specific circumstances where they allow it, or where in the process the harvested tumor is frozen (following resection, after the TILs are selected, or after they are fully expanded/grown). But I know of several folks who have had this done and banked their tumor/TILs for future possible use.
The basic TIL protocol is the same as at NIH's. I think NIH may have some new variations they're trying with both the preparatory regimens (adding total body irradiation and varying the amount of chemotherapy) and the post-infusion IL-2 (trying to reduce or eliminate it), which may provide more options for patients to meet some of the eligibility criteria. Also, Moffitt (in Tampa) has a trial (or trials) with Lion Biotechnologies, who have licensed the NIH processes in hopes of turning it into a product. I think their current trials are combinations with ipi and another with nivo, so that could be a problem if you've already had either. However, to Mat's point, it's certainly worth a call to MDA and perhaps also Moffitt, as it may give you more options and chances to meet the trial criteria.
Joe
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- November 8, 2014 at 6:43 am
I don't know if MDA is less stringent than NIH, but the more I think it the more true it is. Nearly a year ago I went to MDA and had a small tumor taken out. They right away offered testing my tumor to grow TIL's. Unfortunately I was coming off a year on BRAF Zelboraf and apparently that changes the tumor. So my TIL's did not grow. After 5 months this year coming off Anti-PD1 my tumor had enough Tcells to grow for the TIL program.
Either way, Artie, you should definitely check out MD Anderson and see if you can go there for TIL if the NIH is giving you the run around.
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- November 8, 2014 at 6:43 am
I don't know if MDA is less stringent than NIH, but the more I think it the more true it is. Nearly a year ago I went to MDA and had a small tumor taken out. They right away offered testing my tumor to grow TIL's. Unfortunately I was coming off a year on BRAF Zelboraf and apparently that changes the tumor. So my TIL's did not grow. After 5 months this year coming off Anti-PD1 my tumor had enough Tcells to grow for the TIL program.
Either way, Artie, you should definitely check out MD Anderson and see if you can go there for TIL if the NIH is giving you the run around.
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- November 8, 2014 at 6:43 am
I don't know if MDA is less stringent than NIH, but the more I think it the more true it is. Nearly a year ago I went to MDA and had a small tumor taken out. They right away offered testing my tumor to grow TIL's. Unfortunately I was coming off a year on BRAF Zelboraf and apparently that changes the tumor. So my TIL's did not grow. After 5 months this year coming off Anti-PD1 my tumor had enough Tcells to grow for the TIL program.
Either way, Artie, you should definitely check out MD Anderson and see if you can go there for TIL if the NIH is giving you the run around.
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- November 8, 2014 at 4:08 pm
Shane, you raise an interesting point that I hadn't heard before. That is, that BRAFi treatment lessens the likelihood of TIL cells growing. I had considered TIL as a Plan B option (I've been on Taf-Mek for more than a year)–but perhaps it is really a Plan C for me. I'll have to remember to ask about this.
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- November 8, 2014 at 4:08 pm
Shane, you raise an interesting point that I hadn't heard before. That is, that BRAFi treatment lessens the likelihood of TIL cells growing. I had considered TIL as a Plan B option (I've been on Taf-Mek for more than a year)–but perhaps it is really a Plan C for me. I'll have to remember to ask about this.
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- November 8, 2014 at 4:08 pm
Shane, you raise an interesting point that I hadn't heard before. That is, that BRAFi treatment lessens the likelihood of TIL cells growing. I had considered TIL as a Plan B option (I've been on Taf-Mek for more than a year)–but perhaps it is really a Plan C for me. I'll have to remember to ask about this.
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- November 8, 2014 at 8:27 pm
Thanks. Yeah I'm quite happy with the folks at NIH/NCI. I think in their heads they are already ready to try to treat me if everything checks out right thus thinking ahead for the washout. So yeah. They are great so far in my opinion. I couldn't ask for better.
I didn't know about that banking thing. Sounds like it could have been useful but then again with the BRAF stuff I took probably not.
Hmm. I've been through 2 BRAF treatments that neither shrank anything. The last I ended in May so hopefully with the help of the keytruda I've got since then the TIL cells will grow. They sure have a huge mass of soft tissue tumor to work with so maybe that will help. We shall see. I'm not going to worry about it.
Artie
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- November 8, 2014 at 8:27 pm
Thanks. Yeah I'm quite happy with the folks at NIH/NCI. I think in their heads they are already ready to try to treat me if everything checks out right thus thinking ahead for the washout. So yeah. They are great so far in my opinion. I couldn't ask for better.
I didn't know about that banking thing. Sounds like it could have been useful but then again with the BRAF stuff I took probably not.
Hmm. I've been through 2 BRAF treatments that neither shrank anything. The last I ended in May so hopefully with the help of the keytruda I've got since then the TIL cells will grow. They sure have a huge mass of soft tissue tumor to work with so maybe that will help. We shall see. I'm not going to worry about it.
Artie
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- November 8, 2014 at 8:27 pm
Thanks. Yeah I'm quite happy with the folks at NIH/NCI. I think in their heads they are already ready to try to treat me if everything checks out right thus thinking ahead for the washout. So yeah. They are great so far in my opinion. I couldn't ask for better.
I didn't know about that banking thing. Sounds like it could have been useful but then again with the BRAF stuff I took probably not.
Hmm. I've been through 2 BRAF treatments that neither shrank anything. The last I ended in May so hopefully with the help of the keytruda I've got since then the TIL cells will grow. They sure have a huge mass of soft tissue tumor to work with so maybe that will help. We shall see. I'm not going to worry about it.
Artie
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