New Vaccine Trial for Stage 2b/c and Stage 3 Resected

Yes, the existance of a "control arm" (either a placebo or some current standard treatment) is frustrating for patients. Unfortunately, in order to determine if a drug really is more effective than what is currently available, there must be a control group. Scientifically, that is absolutely, positively required. Doctors, researchers, and the FDA do not want to be approving expensive, often dangerous, drugs that really are no better than what is available already. In point of fact, 75% of the drugs that enter Phase 1 testing never get past Phase 2 or Phase 3 because as the studies get larger and the statistics more reliable, the drugs fail to show any real benefit. If such drugs were approved, the pharmaceutical companies would essentially be making a ton of money while offering false hope to patients. So control arms are necessary. 

That being said, the study described here is enrolling 2/3 of the patients in the experimental (vaccine) arm and 1/3 in the control (placebo) arm. That is good news for your sister. A few clinical trials allow "cross-overs", which means that if someone in the control arm develops new tumors, they can request to be switched to the experimental arm. You would have to ask the clinical trial coordinator if cross-overs are allowed for this study. 

No matter what melanoma stage one is in, choosing a treatment option is difficult and scary. It might help you to bear in mind that up until a year or two ago, there were NO viable treatments for melanoma. We are fortunate to be living in a time where so many promising new drugs are available to us through clinical trials. 

Thank you very much for your prompt reply. I understand things better now. And yes, we're very grateful that all this is happening now compared to just a short time ago when choices were so few (though I wasn't aware that it was that recently that those choices were made available.) -Also grateful that we live relatively close to one of the finest cancer treatment centers that there is. And we're excited at the chance for sis to be among the very persons who may offer hope to thousands more in the future.
I'll let sis know that she can ask about "cross-over" options with this trial. 

And again, if anyone has any more information on this, we'd be very grateful if you'd share.

Thanks again,

Kay

Thank you very much for your prompt reply. I understand things better now. And yes, we're very grateful that all this is happening now compared to just a short time ago when choices were so few (though I wasn't aware that it was that recently that those choices were made available.) -Also grateful that we live relatively close to one of the finest cancer treatment centers that there is. And we're excited at the chance for sis to be among the very persons who may offer hope to thousands more in the future.
I'll let sis know that she can ask about "cross-over" options with this trial. 

And again, if anyone has any more information on this, we'd be very grateful if you'd share.

Thanks again,

Kay

Thank you very much for your prompt reply. I understand things better now. And yes, we're very grateful that all this is happening now compared to just a short time ago when choices were so few (though I wasn't aware that it was that recently that those choices were made available.) -Also grateful that we live relatively close to one of the finest cancer treatment centers that there is. And we're excited at the chance for sis to be among the very persons who may offer hope to thousands more in the future.
I'll let sis know that she can ask about "cross-over" options with this trial. 

And again, if anyone has any more information on this, we'd be very grateful if you'd share.

Thanks again,

Kay

Yes, the existance of a "control arm" (either a placebo or some current standard treatment) is frustrating for patients. Unfortunately, in order to determine if a drug really is more effective than what is currently available, there must be a control group. Scientifically, that is absolutely, positively required. Doctors, researchers, and the FDA do not want to be approving expensive, often dangerous, drugs that really are no better than what is available already. In point of fact, 75% of the drugs that enter Phase 1 testing never get past Phase 2 or Phase 3 because as the studies get larger and the statistics more reliable, the drugs fail to show any real benefit. If such drugs were approved, the pharmaceutical companies would essentially be making a ton of money while offering false hope to patients. So control arms are necessary. 

That being said, the study described here is enrolling 2/3 of the patients in the experimental (vaccine) arm and 1/3 in the control (placebo) arm. That is good news for your sister. A few clinical trials allow "cross-overs", which means that if someone in the control arm develops new tumors, they can request to be switched to the experimental arm. You would have to ask the clinical trial coordinator if cross-overs are allowed for this study. 

No matter what melanoma stage one is in, choosing a treatment option is difficult and scary. It might help you to bear in mind that up until a year or two ago, there were NO viable treatments for melanoma. We are fortunate to be living in a time where so many promising new drugs are available to us through clinical trials. 

Yes, the existance of a "control arm" (either a placebo or some current standard treatment) is frustrating for patients. Unfortunately, in order to determine if a drug really is more effective than what is currently available, there must be a control group. Scientifically, that is absolutely, positively required. Doctors, researchers, and the FDA do not want to be approving expensive, often dangerous, drugs that really are no better than what is available already. In point of fact, 75% of the drugs that enter Phase 1 testing never get past Phase 2 or Phase 3 because as the studies get larger and the statistics more reliable, the drugs fail to show any real benefit. If such drugs were approved, the pharmaceutical companies would essentially be making a ton of money while offering false hope to patients. So control arms are necessary. 

That being said, the study described here is enrolling 2/3 of the patients in the experimental (vaccine) arm and 1/3 in the control (placebo) arm. That is good news for your sister. A few clinical trials allow "cross-overs", which means that if someone in the control arm develops new tumors, they can request to be switched to the experimental arm. You would have to ask the clinical trial coordinator if cross-overs are allowed for this study. 

No matter what melanoma stage one is in, choosing a treatment option is difficult and scary. It might help you to bear in mind that up until a year or two ago, there were NO viable treatments for melanoma. We are fortunate to be living in a time where so many promising new drugs are available to us through clinical trials.