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Stage 1 clinical trials take healthy individuals, give them the drug, and wait to see if it kills them. To go from stage 1, through stage 2 (which determines ef
by abtinf 15y ago
Stage 1 clinical trials take healthy individuals, give them the drug, and wait to see if it kills them. To go from stage 1, through stage 2 (which determines effectiveness), through stage 3 (which determines safety for general distribution) takes 10-15 years.
In other words, this is not news. There are probably hundreds of similar clinical trials every year.
- Gatsky 15y agoNot quite. Phase I trials often happen in patients with the disease, because otherwise the data you get on toxicity aren't that relevant. Definitive efficacy is established in a phase III trial, along with safety. en.wikipedia.org/wiki/Phases_of_clinical_research This trial is news-worthy for a few reasons. One is that the only documented cases of cure of a disseminated cancer are proabably all due to an immune-mediated attack (exceptions are lymphomas and testicular cancers which can be cured with chemotherapy even if widespread). Vaccines are trying to exploit this mechanism. Another reason is that most of the treatments we use in phase I trials are poorly understood. The treatment employed in this study however utilises a pretty simple and elegant approach - find something that only cancer cells have, then try and bait the immune system with it.
- uptown 15y ago"The purpose of this study is to test the safety of a treatment called DC205 NY ESO 1 vaccine, given with and without sirolimus, and to see what effects (good or bad) it has on you and your type of cancer." http://www.roswellpark.org/clinical-trials/list/191511 http://www.roswellpark.org/clinical-trials/list/191511