Director, Clinical Experimental Therapeutics Program
Director, Clinical Experimental Therapeutics Program
500 University Drive
Hershey, PA 17033
Phone: (717) 531-3012
“I just didn’t believe that this support existed. It was a dream come true, but even more."
Under Dr. Brown’s leadership, the early phase clinical research enterprise was expanded and re-organized and the Experimental Therapeutics Research and Clinical Team (ExTRaCT) was established. The mission of this Experimental Therapeutics Program is to provide novel, biologically relevant treatment regimens that incorporate cutting-edge science to pediatric and AYA patients with cancer with the goal of becoming a leader of Phase I/II Clinical Trials site.
The makeup of ExTRaCT includes 6 physicians, 1 nurse practitioner, 1 clinical specialist pharmacist, 1 clinical research nurse and 1 regulatory/compliance specialist all within the Division of Pediatric Hematology/Oncology. The objectives of ExTRaCT is to identify and expedite screening of potential patients for participation in early phase clinical trials, consult and consent potential early phase study patients and their families, participate in a “shared-care” model with the patients’ primary oncologists, and to ensure thorough documentation.
In addition, ExTRaCT members help identify and implement innovative early phase clinical studies, develop SOP’s and policies for the Experimental Therapeutics Program, develop strategies to increase visibility of ExTRaCT to the entire Penn State Health community as well as regionally and nationally, educate and act as role models for fellows and peers and identify opportunities for scholarly work.
Also under Dr. Brown’s direction, in 2014, Penn State Hershey became a member of the Neuroblastoma and Medulloblastoma Translational Research Consortium (NMTRC). The NMTRC is a network of more than 20 universities, children’s hospitals, and institutions that offers a number of early phase clinical trials including one clinical trial using a very novel, individualized approach of determining the treatment plan based upon the unique biologic properties of the tumor itself. For a number of different cancer types, relapsed or refractory disease is typically incurable with today’s therapies.
In this study led by the NMTRC, biopsies of the patient’s tumor(s) are obtained and then sent to TGen for sophisticated, cutting-edge genomic analysis of the individual tumor. Based on the molecular aberrations within the tumor, a report that predicts potential response of the individual tumor to over 200 drugs and naturally occurring compounds is generated. Then, a panel of NMTRC members, consisting of pediatric oncologists, pharmacists, pathologists and scientists, holds a “virtual tumor board” during which time the patient’s clinical course is reviewed, the results of the report discussed and a molecularly guided treatment plan (that is based upon the specific tumor analysis) is devised. Then, the patient begins his/her personalized, molecularly guided therapy.
The following are publications of Dr. Brown:
Dinardo L, Brown, V, Perez E, Brunin N, Sullivan K: A Single Center Study of Hematopoietic Stem Cell Transplantation for Primary Immune Deficiencies (PIDD). Pediatric Transplantation, 16(1):63-72, 2012.
Barrett D, Brown VI, Grupp SA, Teachey DT: Targeting the PI3K/Akt/mTOR Signaling Axis in Children with Hematologic Malignancies. Pediatric Drugs, 14(5):299-316, 2012. (PMID: 22845486)
Frangoul H, Min E, Wang W, Chandrasekhar R, Calder C, Evans M, Manes B, Bruce K, Brown V, Ho R, Domm J: Incidence and risk factors for hypogammaglobulinemia in pediatric patients following allo-SCT. Bone Marrow Transplantation, 48(11):1456-9, 2013. (PMID:23708706)
Maheshwari S, Kassim A, Yef RF, Domm J, Calder C, Evans M, Manes B, Bruce K, Brown V, Ho R, Frangoul H, Yang E: Targeted Busulfan therapy with a steady-state concentration of 600- 700 ng/mL in patients with sickle cell disease receiving HLA-identical sibling bone marrow transplant. Bone Marrow Transplantation, 49(3):366-9, Mar 2014. (PMID: 24317124)
Brown V.I.: Entry on "Graft versus Host Disease". In: The 5 Minute Pediatric Consult, 7th Edition. Michael D. Cabana, et al (eds.). Lippincott Williams and Wilkins, Baltimore, MD, in press.
Burke MJ, Verneris MR, Le Rademacher J, He W, Abdel-Azim H, Abraham AA, Auletta JJ, Ayas M, Brown VI, Cairo MS, Chan KW, Diaz Perez MA, Dvorak CC, Egeler RM, Guilcher GMT, Hayashi RJ, Kasow KA, Leung WH, Olsson RF, Pulsipher MA, Shah NN, Thiel E, Kitko CL: Transplant Outcomes for Children with T-Cell Acute Lymphoblastic Leukemia in Second Remission: A Report of the CIBMTR®. Biology of Blood and Marrow Transplantation, 21(12): 2154-9, Dec 2015. (PMID: 26327632)
Khandelwal P, Millard HR, Thiel E, Abdel-Azim H, Abraham AA, Auletta JJ, Boulad F, Brown VI, Camitta BM, Chan KW, Chaudhury S, Cowan MJ, Angel-Diaz M, Gadalla SM, Gale RP, Hale G, Kasow KA, Keating AK, Kitko CL, MacMillan ML, Olsson RF, Page KM, Seber A, Smith AR, Warwick AB, Wirk B, Mehta PA: Hematopoietic Stem Cell Transplantation Activity in Pediatric Cancer between 2008 and 2014 in the United States: A CIBMTR Report. Biology of Blood and Marrow Transplantation, 23(8): 1342-9, Aug 2017. (PMID:28450183)
Bitan M, Ahn KW, Millard HR, Pulsipher MA, Abdel-Azim H, Auletta JJ, Brown VI, Chan KW, Diaz MA, Dietz A, Vincent MG, Guilcher G, Hale G, Hayashi RJ, Keating A, Mehta P, Myers K, Page K, Prestige T, Shah N, Smith AR, Woolfrey A, Thiel E, Davies SM, Eapen M: Personalized Prognostic Risk Score for Long-Term Survival for Children with Acute Leukemia after Allogeneic Transplant. Biology of Blood and Marrow Transplantation, 23 (9): 1523-30, Sept 2017. (PMID: 28527984)
Slayton W, Schultz K, Kairalla JA, Devidas M, Mi X, Pulsipher M, Chang BH, Mulligan CG, Iacobucci I, Silverman LB, Borowitz MJ, Carroll AJ, Heerema NA, Gastier-Foster JM, Wood BL, Mizrahy SL,Merchant TE, Brown VI, Sieger L, Siegal MJ, Raetz EA, Winick NJ, Loh ML, Carroll WL, Hunger SP: Dasatinib plus intensive chemotherapy in children, adolescents, and young adults with Philadelphia chromosome positive acute lymphoblastic leukemia: Results of Children’s Oncology Group trial AALL0622. J Clinical Oncology, accepted.