DESCRIPTION (provided by applicant): The purpose of this grant is to support the scientific and clinical activities of Cancer and Leukemia Group B (CALGB) by providing necessary infrastructure to the CALGB program at The Ohio State University (OSU). The multi-disciplinary collaborative research approach at OSU has a track record of providing more effective methods of prevention, detection and treatment of adult cancer, with a particular focus on breast, gastrointestinal, genitourinary, hematologic, and respiratory malignancies. This research focuses the efforts of medical, hematologic, surgical and radiation oncologists, transplanters, psychiatrists, pathologists, cytogeneticists, translational and basic laboratory scientists, statisticians, epidemiologists, nurses, pharmacists, and clinical research coordinators on well designed and conducted studies asking interrelated clinical and basic science questions whose answers contribute importantly to patient care and to reduction of cancer in populations at increased risk. This project includes the: 1) study of new therapeutic agents, and their toxicities, in Phase I, II and III clinical trials; 2) evaluation of efficacy and toxicity of new regimens including combinations of new and old agents in an effort to exploit synergistic combinations more effectively; 3) development of multi-modal approaches to specific tumor problems using surgical, immunological and radiotherapeutic measures in optimal combinations; 4) involvement of pertinent basic science disciplines such as molecular genetics, biochemistry, pharmacology, immunology, and biostatistics in the design and execution of specific therapy protocols; 5) improvement of cancer care in the community by using these protocols to educate pre- and post-doctoral students, nurses, allied medical personnel and physicians, 6) evaluation of biologic studies in correlation with clinical endpoints to develop more rationally based cancer management, 7) evaluation of cancer controls efforts such as early detection, and 8) study of the psycho-social aspects of cancer. Under the overall coordination of Clara D. Bloomfield, M.D., OSU contributes to CALGB activities through patient accrual to protocols, development and leadership of research protocols, leadership and participation in the scientific and administrative committees of CALGB, housing of multiple CALGB core labs and facilities, CALGB meeting participation and authorship on Group publications. In addition, OSU performs institutional pilots and provides lab data that lead to new CALGB studies. Support of this program should increase our ability to prevent, detect, treat and cure adult cancer and improve the quality of life of cancer survivors.
PRINCIPAL INVESTIGATOR:
Dr Clara Bloomfield has been the PI of the OSU institutional CALGB grant since 1999. She is the past Director of the Comprehensive Cancer Center at OSU and has participated in CALGB since 1972. She has been active in the leadership of CALGB and has served on the Board of Directors since 1982. During this reporting period she chaired one active CALGB protocol and chairs one in development. She is well suited to her position, demonstrating a thorough understanding of the conduct of multi-institutional clinical trials in cancer treatment and relevant laboratory studies.
PROTECTION OF HUMAN SUBJECTS (Resume): ACCEPTABLE
There are no concerns with respect to human subject protection.
INCLUSION OF WOMEN PLAN (Resume): ACCEPTABLE
Enrollment of women is acceptable.
INCLUSION OF MINORITIES PLAN (Resume): ACCEPTABLE
OSU has been reasonably effective in recruiting underrepresented populations to clinical trials; although the proportion of non-white racial minorities among new patients seen at the OSU Cancer Center is less than that observed in the primary catchment area (10.8% versus 12.5). The last year of enrollment demonstrated the greatest representation of minorities (12.7%), exceending the minority representation in the catchment area and of patients seen at OSU. This is acceptable.
INCLUSION OF CHILDREN PLAN (Resume): ACCEPTABLE
Patients greater than 18 years of age are enrolled. This is acceptable.
OVERALL RECOMMENDATION:
This application is rated excellent and recommended for six years of support. |