Advice on first step

Hey Naomi,

I'm not an expert or anything, but I was on Temodar for a short time and it didn't work for me. Frankly, my oncologist didn't think it would work either, it was just that, at the time, he was trying to get me into a clinical trial and the trail required that you'd tried and failed on a chemotherapy. Though I can't speak to the complexities of your father's situation (i.e., whether or not clinical trials will allow him to take part given his kidney transplant), I would definitely get a second opinion about that (unless of course this doctor is 100% certain that he can't take part in a clinical trial and you trust him/her 100%). As to your question about the difference between protocol and off-protocal treatments, the most simple difference is that off-protocal treatments are approved drugs so your doctor can give them to anyone they want in any combination of drugs that they think safe (and, of course, your insurance approves). Protocal treatment (or clinical trials) means that the drug companies are still testing the drug so can therefore limit the participants to anyone they want. For instance, many trials won't allow people who have brain tumors. Again, I don't know about restrictions due to organ transplants, so you'll want to check into that. I do, however, believe that there are many more promising melanoma drugs than Abraxane and Temodar, so perhaps look through this forum and see what drugs people seem excited about. Also, always a good idea to post a profile so that people know the details of what your father's going through, and can more accurately be of assistance.

Best of luck!

Josh

Hey Naomi,

I'm not an expert or anything, but I was on Temodar for a short time and it didn't work for me. Frankly, my oncologist didn't think it would work either, it was just that, at the time, he was trying to get me into a clinical trial and the trail required that you'd tried and failed on a chemotherapy. Though I can't speak to the complexities of your father's situation (i.e., whether or not clinical trials will allow him to take part given his kidney transplant), I would definitely get a second opinion about that (unless of course this doctor is 100% certain that he can't take part in a clinical trial and you trust him/her 100%). As to your question about the difference between protocol and off-protocal treatments, the most simple difference is that off-protocal treatments are approved drugs so your doctor can give them to anyone they want in any combination of drugs that they think safe (and, of course, your insurance approves). Protocal treatment (or clinical trials) means that the drug companies are still testing the drug so can therefore limit the participants to anyone they want. For instance, many trials won't allow people who have brain tumors. Again, I don't know about restrictions due to organ transplants, so you'll want to check into that. I do, however, believe that there are many more promising melanoma drugs than Abraxane and Temodar, so perhaps look through this forum and see what drugs people seem excited about. Also, always a good idea to post a profile so that people know the details of what your father's going through, and can more accurately be of assistance.

Best of luck!

Josh

Hey Naomi,

I'm not an expert or anything, but I was on Temodar for a short time and it didn't work for me. Frankly, my oncologist didn't think it would work either, it was just that, at the time, he was trying to get me into a clinical trial and the trail required that you'd tried and failed on a chemotherapy. Though I can't speak to the complexities of your father's situation (i.e., whether or not clinical trials will allow him to take part given his kidney transplant), I would definitely get a second opinion about that (unless of course this doctor is 100% certain that he can't take part in a clinical trial and you trust him/her 100%). As to your question about the difference between protocol and off-protocal treatments, the most simple difference is that off-protocal treatments are approved drugs so your doctor can give them to anyone they want in any combination of drugs that they think safe (and, of course, your insurance approves). Protocal treatment (or clinical trials) means that the drug companies are still testing the drug so can therefore limit the participants to anyone they want. For instance, many trials won't allow people who have brain tumors. Again, I don't know about restrictions due to organ transplants, so you'll want to check into that. I do, however, believe that there are many more promising melanoma drugs than Abraxane and Temodar, so perhaps look through this forum and see what drugs people seem excited about. Also, always a good idea to post a profile so that people know the details of what your father's going through, and can more accurately be of assistance.

Best of luck!

Josh

Hi, Naomi. I'm sorry to hear about your father's troubles. We could help you better if you would complete a profile so we would have more informaiton about his situation. You do not say, for example, what stage of melanoma your father has or ifhe has brain mets. Since the oncologist is recommending Temodar, I am going to assume that he does have brain mets.

It sounds as though he has a very caring and thoughtful oncologist who is willing to work with you. That's great. Is your father being treated at a melanoma Center of Excellence? If not, you should consult with a Center of Excellence before making a final decision about treatment. Things are changing so fast in this field that it is difficult for a general oncologist to keep up with it. 

Several of the newer melanoma treatments are designed to stimulate the immune system to attack melanoma. This includes Ipi (Yervoy) which is FDA approved, as well as anti-PD1, anti-PDL1, and others. If your father is on immunosuppressants because of his kidney transplant, these treatments are not appropriate. However, there are 4 treatments that are called "targeted chemo" and are drugs designed to specifically designed to attack the melanoma cells. Those include Zelboraf (FDA approved) as well as MEK, dabrafenib, LGX818, and a few others. These are in clinical trials and may be appropriate for your father. Some of them do allow patients with brain mets. Also, your oncologist is correct that Zelboraf + MEK has a better chance of working long term than does Zelboraf alone. I think there is still a ongoing clinical trial combining these two and that trial is allowing people with brain mets. 

You don't say how sick your father is, how widespread is his disease, or where he lives. Those are all important considerations. But the best thing you can do is 1) make sure your father consults with a specialized melanoma clinic, and 2) research clinical trials on your own at http://www.clinicaltrials.gov and any trials that seem appropriate with your oncologist. 

Hi, Naomi. I'm sorry to hear about your father's troubles. We could help you better if you would complete a profile so we would have more informaiton about his situation. You do not say, for example, what stage of melanoma your father has or ifhe has brain mets. Since the oncologist is recommending Temodar, I am going to assume that he does have brain mets.

It sounds as though he has a very caring and thoughtful oncologist who is willing to work with you. That's great. Is your father being treated at a melanoma Center of Excellence? If not, you should consult with a Center of Excellence before making a final decision about treatment. Things are changing so fast in this field that it is difficult for a general oncologist to keep up with it. 

Several of the newer melanoma treatments are designed to stimulate the immune system to attack melanoma. This includes Ipi (Yervoy) which is FDA approved, as well as anti-PD1, anti-PDL1, and others. If your father is on immunosuppressants because of his kidney transplant, these treatments are not appropriate. However, there are 4 treatments that are called "targeted chemo" and are drugs designed to specifically designed to attack the melanoma cells. Those include Zelboraf (FDA approved) as well as MEK, dabrafenib, LGX818, and a few others. These are in clinical trials and may be appropriate for your father. Some of them do allow patients with brain mets. Also, your oncologist is correct that Zelboraf + MEK has a better chance of working long term than does Zelboraf alone. I think there is still a ongoing clinical trial combining these two and that trial is allowing people with brain mets. 

You don't say how sick your father is, how widespread is his disease, or where he lives. Those are all important considerations. But the best thing you can do is 1) make sure your father consults with a specialized melanoma clinic, and 2) research clinical trials on your own at http://www.clinicaltrials.gov and any trials that seem appropriate with your oncologist. 

Hi, Naomi. I'm sorry to hear about your father's troubles. We could help you better if you would complete a profile so we would have more informaiton about his situation. You do not say, for example, what stage of melanoma your father has or ifhe has brain mets. Since the oncologist is recommending Temodar, I am going to assume that he does have brain mets.

It sounds as though he has a very caring and thoughtful oncologist who is willing to work with you. That's great. Is your father being treated at a melanoma Center of Excellence? If not, you should consult with a Center of Excellence before making a final decision about treatment. Things are changing so fast in this field that it is difficult for a general oncologist to keep up with it. 

Several of the newer melanoma treatments are designed to stimulate the immune system to attack melanoma. This includes Ipi (Yervoy) which is FDA approved, as well as anti-PD1, anti-PDL1, and others. If your father is on immunosuppressants because of his kidney transplant, these treatments are not appropriate. However, there are 4 treatments that are called "targeted chemo" and are drugs designed to specifically designed to attack the melanoma cells. Those include Zelboraf (FDA approved) as well as MEK, dabrafenib, LGX818, and a few others. These are in clinical trials and may be appropriate for your father. Some of them do allow patients with brain mets. Also, your oncologist is correct that Zelboraf + MEK has a better chance of working long term than does Zelboraf alone. I think there is still a ongoing clinical trial combining these two and that trial is allowing people with brain mets. 

You don't say how sick your father is, how widespread is his disease, or where he lives. Those are all important considerations. But the best thing you can do is 1) make sure your father consults with a specialized melanoma clinic, and 2) research clinical trials on your own at http://www.clinicaltrials.gov and any trials that seem appropriate with your oncologist. 

Sorry to hear about your father, but I want to express that your oncologist is most likely right about the clinical trials.  Typically, they have fairly strict enrollment criteria and having any other serious disease is most likely a disqualification.  Having a kidney transplant would most likely disqualify him from all trials.  Depending on the drug being administered, diabetes could also be a disqualifying factor.

Off protocol:  To get a drug off protocol, the clinical trial would have to accept him "just because".  The data they received could not be included in their study.  The trial would still be paying for the drug and following your father just as they would any other patient in their study, but his data would be tabulated separately.  I'm honestly not sure how many companies provide any off protocol positions.  I used to work for a medical device manufacturer and in the one clinical trial I was familiar with, we had maybe 2 or 3 off protocol patients.  One was a trial doctor's father and I believe two others were recommended by a doctor but were maybe "sicker" than was allowed for the treatment.  You'd most likely have to be working with a doctor on a particular study and that doctor would have to be fairly certain that the disqualifying factors for the trial would not be a real detriment to to patient if they were to receive the drug.  Also, the company providing the drug would have to allow for extra drug to be provided gratis.  Given your father's condition, off protocol might be the only way he can get a drug in clinical trials, but I'm not certain how often that might actually happen.

Off label:  This is when a drug has been FDA approved for a different cancer/condition.  It can be tried off label for other cancers, but may not be covered by insurance if not used for an approved condition.  In those cases, it might still be deemed "experimental" by the insurance companies.

Sorry to hear about your father, but I want to express that your oncologist is most likely right about the clinical trials.  Typically, they have fairly strict enrollment criteria and having any other serious disease is most likely a disqualification.  Having a kidney transplant would most likely disqualify him from all trials.  Depending on the drug being administered, diabetes could also be a disqualifying factor.

Off protocol:  To get a drug off protocol, the clinical trial would have to accept him "just because".  The data they received could not be included in their study.  The trial would still be paying for the drug and following your father just as they would any other patient in their study, but his data would be tabulated separately.  I'm honestly not sure how many companies provide any off protocol positions.  I used to work for a medical device manufacturer and in the one clinical trial I was familiar with, we had maybe 2 or 3 off protocol patients.  One was a trial doctor's father and I believe two others were recommended by a doctor but were maybe "sicker" than was allowed for the treatment.  You'd most likely have to be working with a doctor on a particular study and that doctor would have to be fairly certain that the disqualifying factors for the trial would not be a real detriment to to patient if they were to receive the drug.  Also, the company providing the drug would have to allow for extra drug to be provided gratis.  Given your father's condition, off protocol might be the only way he can get a drug in clinical trials, but I'm not certain how often that might actually happen.

Off label:  This is when a drug has been FDA approved for a different cancer/condition.  It can be tried off label for other cancers, but may not be covered by insurance if not used for an approved condition.  In those cases, it might still be deemed "experimental" by the insurance companies.

Sorry to hear about your father, but I want to express that your oncologist is most likely right about the clinical trials.  Typically, they have fairly strict enrollment criteria and having any other serious disease is most likely a disqualification.  Having a kidney transplant would most likely disqualify him from all trials.  Depending on the drug being administered, diabetes could also be a disqualifying factor.

Off protocol:  To get a drug off protocol, the clinical trial would have to accept him "just because".  The data they received could not be included in their study.  The trial would still be paying for the drug and following your father just as they would any other patient in their study, but his data would be tabulated separately.  I'm honestly not sure how many companies provide any off protocol positions.  I used to work for a medical device manufacturer and in the one clinical trial I was familiar with, we had maybe 2 or 3 off protocol patients.  One was a trial doctor's father and I believe two others were recommended by a doctor but were maybe "sicker" than was allowed for the treatment.  You'd most likely have to be working with a doctor on a particular study and that doctor would have to be fairly certain that the disqualifying factors for the trial would not be a real detriment to to patient if they were to receive the drug.  Also, the company providing the drug would have to allow for extra drug to be provided gratis.  Given your father's condition, off protocol might be the only way he can get a drug in clinical trials, but I'm not certain how often that might actually happen.

Off label:  This is when a drug has been FDA approved for a different cancer/condition.  It can be tried off label for other cancers, but may not be covered by insurance if not used for an approved condition.  In those cases, it might still be deemed "experimental" by the insurance companies.