Failed BRAF! This Sucks! What Now?

Thanks Jerry,

All I can do is research and present my findings to my husband…ultimately, he says it is his body, his cancer, his decision.  I will be here to hold everything together and support him.

Jan

Thanks Jerry,

All I can do is research and present my findings to my husband…ultimately, he says it is his body, his cancer, his decision.  I will be here to hold everything together and support him.

Jan

I have spent all week looking for info on this and can find very little.  The side effects are scary and results are unknown,  so my husband has been reluctant to jump into this trial.   He has also postponed the challenge of IL-2. 

Ultimately, it is his decision!!   I simply get him as much information as I can, to help him make the choice that he feels is best for him.  And than support him, no matter which treatment he decides to do.

If anyone has more info on  VEGF, please share it with us.

Thank you

Jan

I have spent all week looking for info on this and can find very little.  The side effects are scary and results are unknown,  so my husband has been reluctant to jump into this trial.   He has also postponed the challenge of IL-2. 

Ultimately, it is his decision!!   I simply get him as much information as I can, to help him make the choice that he feels is best for him.  And than support him, no matter which treatment he decides to do.

If anyone has more info on  VEGF, please share it with us.

Thank you

Jan

We just got word that he failed the BRAF four days before Christmas.  My husband decided to just enjoy the holidays, not worry too much (I do that for him) and postpone the decision until after Christmas.  We have to wait 28-30 days to even get into a new trial, so one week did not seem to matter much.  He will make a decision this week.  But, the Dr said if we choose IPI, we cannot qualify for the VEGF.

There are not a lot of results for the VEGF as it is very new and not open everywhere yet.  Dirk is concerned about trying a brand new trial with no improvement stats and lots of risky side effects.  

He wants to make sure that the quality of his life will not suffer long term damage while trying to improve the quantity.  This will be a consideration when he chooses treatment.

Jan

We just got word that he failed the BRAF four days before Christmas.  My husband decided to just enjoy the holidays, not worry too much (I do that for him) and postpone the decision until after Christmas.  We have to wait 28-30 days to even get into a new trial, so one week did not seem to matter much.  He will make a decision this week.  But, the Dr said if we choose IPI, we cannot qualify for the VEGF.

There are not a lot of results for the VEGF as it is very new and not open everywhere yet.  Dirk is concerned about trying a brand new trial with no improvement stats and lots of risky side effects.  

He wants to make sure that the quality of his life will not suffer long term damage while trying to improve the quantity.  This will be a consideration when he chooses treatment.

Jan

Thanks Emily, I will research this trial too!

It's frustrating because we have to wait 28-30 days for several of these trials.  I am reading all of the material on the trials, but there are so many definitions that I don't understand…feel like I need a medical degree!

Jan

Thanks Emily, I will research this trial too!

It's frustrating because we have to wait 28-30 days for several of these trials.  I am reading all of the material on the trials, but there are so many definitions that I don't understand…feel like I need a medical degree!

Jan

Sorry, I know this a long response!

Ok, cried myself to sleep last night!  Fired up the computer this morning and let the fingers fly!!

Option # 1 – Eisai Trial NCT01136967  Looked up a few things: There have been limited (5) trials so far with this drug (about 300 patients) in Europe, USA & Japan.

An Open-Label, 2-Cohort, Multicenter, Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma

Description:

This is a multicenter, open-label, 2-cohort, phase 2 study to assess the objective response rate of E7080 in previously treated subjects with American Joint Committee on Cancer (AJCC) unresectable stage III or stage IV melanoma and disease progression.

Cohort 1 will enroll subjects not harboring the V600E BRAF mutation with disease progression following first-line standard of care therapy, and

Cohort 2 will enroll subjects harboring the V600E BRAF mutation with disease progression following BRAF-V600E-targeted therapy. Eligible subjects must have measurable disease according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

You take 24 mg of E7080 pills once per day (3 pills, two 10mg and one 4 mg).

Visits to Dr. on day 1 and day 15 of 28 day cycles for blood & urine testing, with  CT and/or MRI every 8 weeks (2 cycles) and every 24 weeks (6 cycles) a bone scan.

Just some of the exclusions:

1. Melanoma of intraocular origin or brain or leptomeningeal metastases.

2. More than 1 prior systemic chemotherapy regimen for unresectable stage III or stage IV disease (if BRAF V600E mutation negative) or not previously treated with BRAF V600E-targeted therapy (if BRAF V600E mutation positive)

3. Any anti-cancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of  study drug.

Exclusion #2 is why we cannot come back to this if we choose the other options.  i just don't know if it worth the time and side effects to try this first.

Very common Side effects: seen in more than 1 in 10 patients

•  high blood pressure (makes sense as the drug is supposed to shrink the blood vessels to the cancer)  

• protein in the urine (may indicate damage to kidneys)

• sore mouth and/ or ulceration

•Dysphonia (impairment in ability to produce voice sounds)???

• nausea or vomiting,  diarrhea,feeling tired or unwell,  loss of appetite, weight loss, headache

There are lots of other side effects listed that are common (anywhere from 1 to 10 people in every 100) too many to list, but some are pretty scary sounding!!!

Exclusion #2 is why we cannot come back to this if we choose the other options.  i just don't know if it worth the time and side effects to try this first.

There are no results listed anywhere (I guess that's why it's called investigational).

I know there are some experts out there in MRF land…give me your input regarding this trial over the other options.

Thanks

Jan (wife to Dirk, stage IV; mets in liver, lungs, kidney, bone, external chest; tried surgery, Interferon and BRAF) 

I asked that already…no results,  trial just opened up, only taking 10 patients at UCLA.

Jan

I asked that already…no results,  trial just opened up, only taking 10 patients at UCLA.

Jan

Sorry, I know this a long response!

Ok, cried myself to sleep last night!  Fired up the computer this morning and let the fingers fly!!

Option # 1 – Eisai Trial NCT01136967  Looked up a few things: There have been limited (5) trials so far with this drug (about 300 patients) in Europe, USA & Japan.

An Open-Label, 2-Cohort, Multicenter, Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma

Description:

This is a multicenter, open-label, 2-cohort, phase 2 study to assess the objective response rate of E7080 in previously treated subjects with American Joint Committee on Cancer (AJCC) unresectable stage III or stage IV melanoma and disease progression.

Cohort 1 will enroll subjects not harboring the V600E BRAF mutation with disease progression following first-line standard of care therapy, and

Cohort 2 will enroll subjects harboring the V600E BRAF mutation with disease progression following BRAF-V600E-targeted therapy. Eligible subjects must have measurable disease according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

You take 24 mg of E7080 pills once per day (3 pills, two 10mg and one 4 mg).

Visits to Dr. on day 1 and day 15 of 28 day cycles for blood & urine testing, with  CT and/or MRI every 8 weeks (2 cycles) and every 24 weeks (6 cycles) a bone scan.

Just some of the exclusions:

1. Melanoma of intraocular origin or brain or leptomeningeal metastases.

2. More than 1 prior systemic chemotherapy regimen for unresectable stage III or stage IV disease (if BRAF V600E mutation negative) or not previously treated with BRAF V600E-targeted therapy (if BRAF V600E mutation positive)

3. Any anti-cancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of  study drug.

Exclusion #2 is why we cannot come back to this if we choose the other options.  i just don't know if it worth the time and side effects to try this first.

Very common Side effects: seen in more than 1 in 10 patients

•  high blood pressure (makes sense as the drug is supposed to shrink the blood vessels to the cancer)  

• protein in the urine (may indicate damage to kidneys)

• sore mouth and/ or ulceration

•Dysphonia (impairment in ability to produce voice sounds)???

• nausea or vomiting,  diarrhea,feeling tired or unwell,  loss of appetite, weight loss, headache

There are lots of other side effects listed that are common (anywhere from 1 to 10 people in every 100) too many to list, but some are pretty scary sounding!!!

Exclusion #2 is why we cannot come back to this if we choose the other options.  i just don't know if it worth the time and side effects to try this first.

There are no results listed anywhere (I guess that's why it's called investigational).

I know there are some experts out there in MRF land…give me your input regarding this trial over the other options.

Thanks

Jan (wife to Dirk, stage IV; mets in liver, lungs, kidney, bone, external chest; tried surgery, Interferon and BRAF) 

Stephanie, I'm sorry to hear about your Mom's battle.  The waiting and limbo have always been hard for us to handle.  It just makes me nuts!  I don't have any answers on adoptive cell.  You might want to search for it on here.  I am sure someone on here can help with that.

Just to update, I have posted more recently.  While trying to qualify for the E7080 trial in January, they found a lesion in my husband's brain.  That bumped us from a lot of trials, so we opted to go right into IPI. We already did the testing and waiting, so there was no more wasted time.  He has had two IPI infusions so far, however, we are still waiting on UCLA to schedule brain radiation.  They did another MRI last Wed for planning purposes.  The one lesion has grown from 3mm to 8mm in the last month and there is now another 6mm lesion in a different area of the brain.  What the hell are they waiting for????  They certainly do not seem to be in any hurry to treat him.  As with everyone, the waiting in crazy!

There are a lot of people on here who can give you hope and support so continue to drop in and write.  This board has saved my sanity several times when I have been on the edge.

Jan in OC, (wife to Dirk,  8/09; stage IV, mets in liver, lungs, kidney, brain; surgery; one month HD Interferon & one month self injections; eleven months BRAF,currently  IPI)

Stephanie, I'm sorry to hear about your Mom's battle.  The waiting and limbo have always been hard for us to handle.  It just makes me nuts!  I don't have any answers on adoptive cell.  You might want to search for it on here.  I am sure someone on here can help with that.

Just to update, I have posted more recently.  While trying to qualify for the E7080 trial in January, they found a lesion in my husband's brain.  That bumped us from a lot of trials, so we opted to go right into IPI. We already did the testing and waiting, so there was no more wasted time.  He has had two IPI infusions so far, however, we are still waiting on UCLA to schedule brain radiation.  They did another MRI last Wed for planning purposes.  The one lesion has grown from 3mm to 8mm in the last month and there is now another 6mm lesion in a different area of the brain.  What the hell are they waiting for????  They certainly do not seem to be in any hurry to treat him.  As with everyone, the waiting in crazy!

There are a lot of people on here who can give you hope and support so continue to drop in and write.  This board has saved my sanity several times when I have been on the edge.

Jan in OC, (wife to Dirk,  8/09; stage IV, mets in liver, lungs, kidney, brain; surgery; one month HD Interferon & one month self injections; eleven months BRAF,currently  IPI)