Clinical Research in Oncology
Geoffrey Uy, MD
Medical Director for Clinical Research
The Division of Oncology at Washington University School of Medicine/Siteman Cancer Center leads one of the largest and most robust clinical cancer research programs in the United States. On average, the Division enrolls 3,000+ patients in more than 600 clinical trials annually, making it the largest cancer research program in the Midwest.
Clinical trials include both observational and interventional studies and cover a broad range of cancer types and therapeutic interventions, with particular expertise in conducting early phase I studies, immunotherapy and cellular therapeutics.
On average, 20% of new oncology patient consults convert to participation in therapeutic clinical trials.
Program Scope
Clinical research efforts are organized around 10 major disease-based groups:
- AIDS-related malignancies
- Breast
- Gastrointestinal
- Genitourinary
- Head and neck
- Hematologic malignancies
- Melanoma
- Neuro-oncology
- Sarcoma
- Thoracic
Program Infrastructure
The Division has an extensive infrastructure to support clinical research, with 160+ dedicated clinical research staff, including clinical research associates, financial coordinators, pharmacists and other support staff. The division also operates an oncology research pharmacy.
The primary clinical research facility is the Siteman Cancer Center on the campus of Barnes-Jewish Hospital and Washington University School of Medicine. Research also is supported at satellite facilities at Barnes-Jewish West County Hospital, Siteman Cancer Center-South County, Barnes-Jewish St. Peters Hospital, Christian Northeast Hospital, and Siteman Cancer Center– Southern Illinois.
The Division also has entered into several strategic relationships with pharmaceutical companies and contract research organizations, including Genentech, Immunotherapy Centers of Research Excellence (imCORETM) Network and the Quintiles Early Phase Oncology Network. It utilizes a central IRB model and operates master clinical trial agreements with more than 25 pharmaceutical companies in order to streamline operations.
Clinical Research Highlights
Clinical research efforts by investigators within the Division have shaped standard of care treatments for cancer patients worldwide. Examples include:
- CXCR4 and VLA4 inhibitors for mobilization of hematopoietic stem and progenitor cells (J. DiPersio)
- Decitabine for the treatment of AML (A. Cashen, J. Welch)
- CD30 monoclonal Ab and Ab-drug conjugates for Hodgkin and T-cell lymphomas (N. Bartlett)
- Nanoliposomal irinotecan for metastatic pancreatic adenocarcinoma (A. Wang-Gillam)
- Use of next generation sequencing to track disease progression and regression and sub-clonal architecture (T. Ley, D. Link, J. Welch, M. Walter)
- Novel HERZ/erb2 TKI for cancer therapy (C. Ma, R. Bose)
Collaborative Research Efforts
The physicians and scientists within the Division are national and international leaders in their respective oncology subspecialties. Many serve as principal investigators for large multi-center, multi-disciplinary clinical trials and are recipients of significant NIH- and industry-sponsored grants. They work collaboratively with researchers in other departments across the medical center campus as well as with investigators in other leading oncology programs across the country and around the world. Several serve as leaders in National Cancer Institute clinical research consortiums, including the Alliance for Clinical Trials in Oncology, Blood and Marrow Transplant Clinical Trials Network, AIDS Malignancy Consortium and the Experimental Therapeutics-Clinical Trials Network. In addition, our investigators are active members of the Multiple Myeloma Research Consortium (MMRC), Hoosier Oncology Group, and Sarcoma Alliance for Research through Collaboration (SARC).
Multi-Institutional Collaborations
Examples of investigator-initiated studies of novel therapeutic approaches and major multicenter clinical trials include:
- Novel bispecific antibodies against for the treatment of acute myeloid leukemia (J. DiPeriso, P. Westervelt)
- Cytokine induced memory like NK-cells for treatment of acute myeloid leukemia (T. Fehniger, R. Romee)
- Registration study of palbociclib plus cetuximab in head and neck cancers (D. Adkins)
- Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (ALCHEMIST) study for EGFR mutated lung cancer (R. Govindan)
- ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) (C. Ma)
- Gene edited CAR-T for treatment of T cell malignancies (J. DiPersio, M. Cooper)
- BCMA-CSI CAR-T for treatment of myeloma (J. DiPersio)
- Novel nanoparticle therapy for myeloma (Achilefu, M. Rettig)
- Novel JAK 1/2 inhibitors for treatment of GVHD (J. Choi)
- First in-human phase I clinical study of IL-15 superagonist complex ALT-803 to treat relapse after allogeneic hematopoietic cell transplantation (R. Romee, M. Berrien-Elliot, P. Westervelt, L. Peck, J. DiPersio, A. Cashen, T. Fehniger)
Current WU Multi-Investigator Grants
NCI Alliance U10 (PI: N. Bartlett)
U10CA180833 - Washington University/Siteman Cancer Center Lead Academic Site – N. Bartlett (Medical Oncology); D. Mutch (OBGYN), B. Siegel (Radiology), B. Kozower (Surgery), C. Robinson (Radiation Oncology)
03/14 - 02/19
The fundamental goal is to create a supportive environment that fosters scientific leadership and mentorship; the development of cooperative group clinical trials; substantial accrual to clinical trials across the entire NCTN; and exceptional conduct of clinical trials.
NCI PDX grant (PI: L. Ding and R. Govindan)
U54CA224083 - Washington University PDX Development and Trial Center (WU-PDTC) – R. Govindan (contact PI), Li Ding, Shunqiang Li
09/17 - 08/22
The WU-PDTC, as part of NCI PDXNet program, is developing and characterizing patient-derived xenografts (PDXs)across all major tumor types to advance the ability to predict clinical responses to new molecularly targeted agents under development.
NCI UM1 Phase I Centers (WU PI: A. Wang-Gillam)
UM1CA186704 - Duke-UNC-Washington University Partnership for Early Phase Clinical Trials in Cancer – A. Wang-Gillam, E. Claire Dees (UNC PI), James Abbruzzese (Duke & contact PI)
04/14 - 02/19
Collaborative goals are to conduct innovative early phase studies through the CTEP ET-CTN experimental therapeutics clinical trials network; expand access to novel clinical trials being conducted; develop innovative strategies and approaches for the development of novel anti-cancer agents and combination regimens; and support the career development of junior faculty interested in early phase cancer drug development.
NIH/NCI: U54 CA199092 Center for Multiple Myeloma Nanotherapy (PI: S. Achilefu, Project 3 Leader: J. DiPersio)
09/15 - 08/20
The objective is to develop nanotherapeutics to treat multiple myeloma.
NIH/NCI: 1 P30 CA91842 Cancer Center Support Grant (PI: T. Eberlein, Deputy Director: J. DiPersio)
01/01 - 07/20
Supports the Siteman Cancer Center of Barnes-Jewish Hospital and Washington University School of Medicine as a multidisciplinary comprehensive cancer research facility dedicated to advancing cancer diagnosis, treatment, and prevention.
NIH/NCI: 1 UG1 HL138669-01 BMT-CTN Use of memory NK cells for haploidentical allogeneic stem cell transplant (PI: P. Westervelt, Co-PI: J. DiPersio)
08/17 - 06/22
The goal is to achieve designation of the Washington University Bone Marrow Transplant program as a Core Clinical Center for the BMT Clinical Trials Network (CTN).
