CF 3: Clinical Trials & Advocacy Core

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CF-3: Clinical Trials and Advocacy Core ABSTRACT Sarcomas are a rare and heterogeneous group of malignancies of mesenchymal origin that affect individuals of all ages. Sarcomas portend a poor prognosis with an estimated three-year survival rate of 20% for patients with metastatic disease. Treatments for patients with sarcoma have greatly lagged behind those available for the epithelial and hematopoietic malignancies. Sarcoma therefore represents an area of unmet potential in which there is a tremendous need for preclinical and clinical advancement. Clinical research on sarcoma presents unique challenges that are inherent to serving a rare patient population with each disease subtype having a unique biologic, pathogenic, genetic, and epigenetic basis that can be characterized and therapeutically exploited. The conduct of clinical trials on sarcoma is a labor-intensive undertaking that requires specific attention, initiatives, infrastructure, and expertise, apart from and in addition to those of any major cancer center. The main objective of the Clinical Trials and Advocacy Core (CF-3) is to support the translational and clinical efforts of the MSKCC SPORE in Soft Tissue Sarcoma. The CF-3 will be jointly run by key members of the adult and pediatric sarcoma programs at Memorial Sloan Kettering Cancer Center (MSKCC), ensuring the fluid application of novel therapies across all age groups. The CF-3 will bridge the adult and pediatric sarcoma programs at MSKCC; the basic science, translational, and clinical aspects of the various SPORE projects; and the Administrative, Biostatistical, and Biospecimen Cores. Additionally, the CF-3 will facilitate seamless clinical collaboration with other Sarcoma SPOREs, cooperative/government funding mechanisms for clinical trials (ETCTN/Cancer Therapy Evaluation Program [CTEP]/Alliance), pharmaceutical companies, advocacy groups, and immune and developmental therapeutic programs. The CF-3 will provide SPORE investigators with expertise in clinical trial development and administration, support staff for the clinical trials, expertise in and administration of clinical trial correlates, financial support for conducting clinical trials and performing correlative studies, and mechanisms for developing and acquiring novel therapies for rare diseases. The CF-3, in close collaboration with the other SPORE cores, will provide the much-needed infrastructure to ensure that the translational mission of the SPORE is realized across age groups in a timely, cost- effective, and cooperative manner. CF-3 will work to facilitate the engagement and involvement of minority participants in our clinical research. CF-3 will also develop a program to involve patient advocacy and support groups, with the goal of developing our clinical trial protocols to best serve the needs of the patients. This aim will also have an educational component, which will allow for conversations between the MSKCC Sarcoma Disease Management Team and patients, caregivers, and advocates.