Project: Research project

Project Details


DESCRIPTION (adapted from applicant's abstract): The overall objective of
this project is to provide support for performance of clinical studies of
the Cancer and Leukemia Group B at the Lombardi Cancer Center at Georgetown
University Medical School. The LCC/GUMC is an NCI-designated Comprehensive
Cancer Center. In 1988, Marc Lippman, M.D., assumed Directorship of the
Lombardi Cancer Center. Under his direction, the Cancer Center was
designated as a Federally Funded Cancer Center in 1989. The Cancer Center
became a Federal designated "Comprehensive Cancer Center" in 1992, and the
Cancer Center Support Grant was renewed in 1996 with an overall rating of
"excellent to outstanding." During the previous funding period, LCC/GUMC
has participated in CALGB studies as an unfunded affiliate institution of
the University of Maryland Cancer Center. In March, 1997, the CALGB Board
of Directors approved LCC/GUMC as a Main Member Institution. At that time,
Dr. Daniel F. Hayes was named as Institutional Principal Investigator.
LCC/GUMC will participate in the entire range of multimodatity clinical
studies, including both therapeutic studies, correlative science studies.
and companion studies of quality of life, survivorship, and cost
effectiveness analyses. LCC faculty have been active in all three areas of
CALGB activities: accrual, scientific leadership, and administrative tasks.
As of May 1, 1997, 41 CALGB protocols were active at LCC/GUMC. A total of
129 patients have entered CALGB studies since LCC entered CALGB in 1990,
with 78 of these during this funding period (1993-1996). Accrual has
increased over the last three years: 1994, 10 patients; 1995, 26 patients,
and 1996, 31 patients. 17 percent of these patients were from minority
populations, and 69 percent of patients entered onto CALGB trials were
women. A recent audit by CALGB rated LCC as "Acceptable." Several
initiative are being used to increase accrual at LCC, including recruitment
of onsite clinical faculty committed to clinical trials, organization of a
highly coordinated Clinical Research Management Office, development of a
clinical Research Consortium of off-site affiliates. and development of a
Patient Accession Core Project. Lombardi has a major program to increase
accrual of minorities and women to clinical trials, coordinated by the
Associate Director of the Cancer Center, Dr. John Kemer. It is estimated
that LCC will accrue 95 patients/year to CALCB therapeutic and companion
studies. LCC faculty are already leaders in CALGB, with 12 cadre committee
members, two of whom are Committee Chairs (Dr. Hayes, Solid Tumor
Correlative Science; Dr. Raymond Weiss, Audit). Five faculty members are
Study Chairs for 11 active CALGB trials or companion studies. Two faculty
have two concepts under review that are likely to open in the next twelve
months. Because of the depth of scientific accomplishments of the LCC
faculty, it is anticipated that many more will assume leadership roles
within CALGB now that LCC/GUMC has Main Member Status. Three faculty have
had administrative roles, including Dr. Raymond Weiss who started and has
been the only Chair of the Audit Committee. The LCC research infrastructure
for clinical and translational science is substantial, and LCC faculty are
expected to provide leadership in developing clinical and correlative
science studies during the next funding cycle. In summary, with Main
Membership status and maturation of the Cancer Center, the LCC is expected
to become one of the leading institutions within the CALGB during the next
five years.
StatusNot started