Roswell Park Cancer Institute (RPCI) has considerable expertise in the development and conduct of pilot/pre-phase I, phase I and phase l/ll studies, which are the foundation for the development of novel therapeutic approaches in hematologic and solid tumor malignancies. Early Phase Clinical Research Support (EPCRS) provides resources for the short-term conduct of early phase agent or device studies developed by RPCI investigators and emanating from the CCSG research programs. The continued vitality and translational potential of CCSG Programs relies critically on this support for early phase studies, which rarely receive support through other mechanisms. With the recent recruitment of a number of new investigators to the CCSG Programs and RPCI, accrual to these studies has increased substantially, for example, from 24 (2008) to 118 (2012) for phase I investigator-initiated studies. Alex A. Adjei, MD, PhD, Associate Director for Clinical Research, oversees this CCSG component. The primary responsibilities of the clinical research coordinators in this Resource are the implementation, conduct, oversight, collection and quality control of data for phase I and pilot studies. Dr. Adjei oversees the prioritization for the use of EPCRS resources in his capacity as Associate Director for Clinical Research. The process builds on established mechanisms and structures through the Protocol Review and Monitoring System to ensure that only high priority, eligible studies receive support. In order to be eligible for support through EPCRS, the study must be led by an RPCI investigator and/or have resulted from clinical or preclinical studies performed by an RPCI investigator with an RPCI faculty member as a co-investigator. In addition, the study should not be supported by peer-reviewed funding, a co-operative agreement or other contracts. Over the last grant period, a number of studies have been initiated that were based on research findings from investigators involved in the CCSG programs. These trials either had laboratory funding but not clinical trial funding or they led to peer-reviewed funding after support by the EPPRS. Examples include phase I studies of TRC105 [Dr. Ben Seon (TM)] DAMD17031046), cixutumumab + eriofinib [Adjei (ET), R21 CAI 35595], Eriofinib chemoprevention [Dr. Mary Reid (PS), N01 CN-35157], and a vaccine study for NY-ESO expressing ovarian and fallopian tube cancers [Dr. Kunle Odunsi/Dr. ProtuI Shrikant (TH), R01CA158318].
Eariy phase clinical research is essential to translating outstanding basic science into clinical care. EPCRS provides critical support to advance the most novel science into clinical testing prior to extramural funding.
|Zhao, Zhiguo; Wen, Wanqing; Michailidou, Kyriaki et al. (2016) Association of genetic susceptibility variants for type 2 diabetes with breast cancer risk in women of European ancestry. Cancer Causes Control 27:679-93|
|Goossens, Maria E; Isa, Fatima; Brinkman, Maree et al. (2016) International pooled study on diet and bladder cancer: the bladder cancer, epidemiology and nutritional determinants (BLEND) study: design and baseline characteristics. Arch Public Health 74:30|
|Clyde, Merlise A; Palmieri Weber, Rachel; Iversen, Edwin S et al. (2016) Risk Prediction for Epithelial Ovarian Cancer in 11 United States-Based Case-Control Studies: Incorporation of Epidemiologic Risk Factors and 17 Confirmed Genetic Loci. Am J Epidemiol 184:579-589|
|Wilton, John; Kurenova, Elena; Pitzonka, Laura et al. (2016) Pharmacokinetic analysis of the FAK scaffold inhibitor C4 in dogs. Eur J Drug Metab Pharmacokinet 41:55-67|
|Sexton, Sandra; Tulowitzki, Ryan; Jones, Craig A et al. (2016) Involvement of the renin-angiotensin system in the development of nephrogenic systemic fibrosis-like lesions in the RenTag mouse model. Clin Exp Nephrol 20:162-8|
|Shafirstein, Gal; Battoo, Athar; Harris, Kassem et al. (2016) Photodynamic Therapy of Non-Small Cell Lung Cancer. Narrative Review and Future Directions. Ann Am Thorac Soc 13:265-75|
|Pharoah, Paul D P; Song, Honglin; Dicks, Ed et al. (2016) PPM1D Mosaic Truncating Variants in Ovarian Cancer Cases May Be Treatment-Related Somatic Mutations. J Natl Cancer Inst 108:|
|Austin, David C; Strand, Douglas W; Love, Harold L et al. (2016) NF-ÎºB and androgen receptor variant 7 induce expression of SRD5A isoforms and confer 5ARI resistance. Prostate 76:1004-18|
|Rohrbach, Daniel J; Rigual, Nestor; Arshad, Hassan et al. (2016) Intraoperative optical assessment of photodynamic therapy response of superficial oral squamous cell carcinoma. J Biomed Opt 21:18002|
|Chinnam, Meenalakshmi; Wang, Xiaoling; Zhang, Xiaojing et al. (2016) Evaluating Effects of Hypomorphic Thoc1 Alleles on Embryonic Development in Rb1 Null Mice. Mol Cell Biol 36:1621-7|
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