› Forums › Cutaneous Melanoma Community › New Vaccine Trial for Stage 2b/c and Stage 3 Resected
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alpineartist.
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- June 6, 2012 at 8:43 pm
I like that there is another new option for those considering Interferon…
From the press release: http://www.polynoma.com/docs/PolynomaCommencesPhaseIIIMelanomaVaccineClinicalTrial.pdf
I like that there is another new option for those considering Interferon…
From the press release: http://www.polynoma.com/docs/PolynomaCommencesPhaseIIIMelanomaVaccineClinicalTrial.pdf
Polynoma’s melanoma vaccine has an extensive clinical history, having been safely administered to over 650 patients. The current Phase III study of POL 103A has been initiated based on the results of two randomized, placebo-controlled Phase II trials that demonstrated strong efficacy in terms of significantly improved Recurrence-free survival (“RFS”) and overall survival (“OS”). Additionally, POL 103A has exhibited an excellent safety profile.
Dr. Chiplin commented, “POL 103A’s strong safety profile and tolerability have a significant advantage over Interferon, which has limited efficacy and poor tolerability despite its being the current standard of care for resected Stage IIb – III melanoma patients, for whom there are currently no other alternatives.”FROM CLINICALTRIALS.GOV
http://www.clinicaltrials.gov/ct2/show/NCT01546571?term=POL+103&rank=1
Eligibility:
Ages Eligible for Study: 18 Years to 75 Years
Inclusion Criteria:
Histologically confirmed Stage IIb, IIc, III melanoma
Surgical resection within 90 days of first dosing
Persons with positive sentinel nodes must have a complete lymphadenectomy
ECOG performance status 0 or 1Exclusion Criteria:
Any prior melanoma treatment other than surgery or regional irradiation
Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin
Use of biologic response modifiers within 60 days of first dosing
Subjects with history of other malignancy within past 5 years (with exceptions)
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- December 8, 2012 at 10:59 am
Hello. Thank you for posting this. I'm new to the board. My sister (IIIA, diag. Sept 2012) is eligible for this trial and will likely enroll. Has anyone else here enrolled? If so, what has been your experience so far?
I understand that placebo is part of the protocol. With such an insidious disease, it would seem that no one should receive placebo but all should be treated in some way. Can anyone explain this to me? And if on placebo, she's been told that it won't be for the duration of the trial. Is this true?Anything more that we can learn about this trial would be a huge help. Thank you all and God bless!
Kay
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- December 8, 2012 at 2:56 pm
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.
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- December 8, 2012 at 5:12 pm
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
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- December 8, 2012 at 5:12 pm
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
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- December 8, 2012 at 5:12 pm
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
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- December 8, 2012 at 2:56 pm
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.
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- December 8, 2012 at 2:56 pm
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.
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- December 8, 2012 at 10:59 am
Hello. Thank you for posting this. I'm new to the board. My sister (IIIA, diag. Sept 2012) is eligible for this trial and will likely enroll. Has anyone else here enrolled? If so, what has been your experience so far?
I understand that placebo is part of the protocol. With such an insidious disease, it would seem that no one should receive placebo but all should be treated in some way. Can anyone explain this to me? And if on placebo, she's been told that it won't be for the duration of the trial. Is this true?Anything more that we can learn about this trial would be a huge help. Thank you all and God bless!
Kay
-
- December 8, 2012 at 10:59 am
Hello. Thank you for posting this. I'm new to the board. My sister (IIIA, diag. Sept 2012) is eligible for this trial and will likely enroll. Has anyone else here enrolled? If so, what has been your experience so far?
I understand that placebo is part of the protocol. With such an insidious disease, it would seem that no one should receive placebo but all should be treated in some way. Can anyone explain this to me? And if on placebo, she's been told that it won't be for the duration of the trial. Is this true?Anything more that we can learn about this trial would be a huge help. Thank you all and God bless!
Kay
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