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Lunch for a Cure 2010 Funding
One of the most important clinical trials ever conceived -- and we are going to fund it!
The purpose of Lunch for a Cure is to fund important neuroblastoma research and this year's beneficiary of our "lunch" money is likely the most deserving of any clinical research project we have ever reviewed. At the end of September 2010, the New England Journal of Medicine published an article which showed that immunotherapy with ch14.18, GM-CSF, and interleukin-2 was associated with a 20% increase in survival as compared with standard therapy in children with high-risk neuroblastoma. This was an important discovery and points to the incredibly talented researchers and physicians that neuroblastoma has fighting for its children. After all, when was the last time you saw a 20% increase in survival for any cancer, if ever? The point is that this was an extraordinarily important finding and one that serves as the foundation of the clinical trial that Lunch for a Cure seeks to fund. Although this is an awe-inspiring discovery, patients with neuroblastoma are still faced with formidable challenges. First, although we have the results, the fact remains that ch14.18 is not an FDA approved drug and also falls victim to limited supply. As a result, it is only available through clinical trial. Unfortunately, for many with refractory or relapsed neuroblastoma, there are not any clinical trials available which provide this important drug. However, the clinical trial that Lunch for a Cure seeks to fund will provide this drug in a clinical trial for this population of children with neuroblastoma. Thus, providing a potentially life-saving and cure-cementing drug to a group of children which would not otherwise have access to it. In this sense, this clinical trial will save lives simply by providing access to a drug for patients that could not otherwise get it. The second obstacle for children with neuroblastoma deals with the toxicities of the drugs given to children along with ch14.18 to make it work optimally. One of the biggest challenges coming out of the article printed in the New England Journal of Medicine, was of developing more effective and less toxic ways to stimulate ch14.18. The proposed clinical trial seeks to utilize Lenalidomide, an FDA approved drug, to overcome these issues. Lenalidomide (CC-5013, Revlimid®) is a structural analog of thalidomide, but with less sedative and neurotoxic side effects. Lenalidomide has demonstrated immunomodulatory effects in both pre-clinical and clinical testing. Two pediatric studies completed to date did not reach a maximum tolerated dose. It is believed that Lennalidomide will both enhance the effectiveness of ch14.18 and reduce toxicity - a win/win scenario for children with neuroblastoma. It is an important study and strong preclinical research indicates that this is the direction of the future. Furthermore, as a research proposal, this garnered some of the best scores achievable for its scientific merit and importance to patients with neuroblastoma. The clinical trial will be run through New Approaches to Neuroblastoma Therapy (NANT), a consortium of hospitals and universities dedicated to developing and testing new therapies aimed at improving the outcome for children with advanced neuroblastoma with fewer side effects. Furthermore, the clinical trial will be guided by many of the same experts that were a part of the original clinical trial that made the discovery which increased survival by 20%. It is for these reasons that Lunch for a Cure has decided to use the funds donated this year to fund this incredibly important clinical trial. It is our belief that funding this trial today will only speed us towards the cure.
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