Scientific Advisory Council
The Scientific Advisory Council was formed to provide guidance
for the upcoming clinical trials of the Sunshine Project and to
select and plan future clinical trials conducted through the Sunshine
Project. The Council is comprised of preeminent doctors and
other leaders in their respective fields from throughout the United
States who can collaborate, each bringing additional resources
that will ultimately benefit the Sunshine Project. The Council
currently includes the following individuals: Dr. Scott Antonio,
Dr. Richard Gorlick, Dr. Steven Grant, Dr. Patricia LoRusso and
Dr. Mace L. Rothenberg.
Dr. Antonia directs a translational research program that
has the overall goal of developing novel immunotherapeutic
strategies for the treatment of cancer patients. The basic
research component of the program is to perform preclinical
proof-of-principle testing of new vaccines, and to determine
the mechanisms by which the tumor microenvironment is hostile
to T cells. The vaccines currently under development are a
GM-CSF/CD40 ligand gene-modified tumor cell vaccine, and dendritic
cell based vaccines. With respect to the study of the tumor
microenvironment, indoleamine 2,3-dioxygenase (IDO) has been
identified as a significant immunosuppressive enzyme produced
by tumor cells. A competitive inhibitor of IDO is currently
being developed as a tumor vaccine augmentation strategy. Optimization
and safety testing of the vaccines and augmentation strategies
in anticipation of FDA IND applications is also performed.
The clinical research component of the translational research
program involves the testing of the vaccines and augmentation
strategies in cancer patients. An infrastructure has been put
into place to accomplish this. A diverse group of investigators
at the H. Lee Moffitt Cancer Center needed to accomplish these
logistically complex clinical trials has been formed, and a vaccine
production facility that operates with standard operating procedures
compliant with current good manufacturing practices is operational.
A phase I B7-1 gene-modified autologous tumor cell vaccine trial
involving patients with metastatic renal cell carcinoma has been
completed, and the phase II trial in ongoing.
A graduate of Brooklyn College, Dr. Gorlick received his MD
degree from the State University of New York Health Science
Center, Brooklyn and completed an internship and residency
in pediatrics at Columbia-Presbyterian Medical Center. He
was a fellow at Memorial Sloan-Kettering Cancer Center and
Faculty Member for eight years before joining the Albert Einstein
College of Medicine in 2004 as an Associate Professor of Pediatrics
and Molecular Pharmacology and Division Chief of Pediatric
Hematology-Oncology at the Children's Hospital at Montefiore.
In 2005 he became the Vice Chairman of Pediatrics. At the Albert
Einstein College of Medicine he is also the Director of the
Sarcoma Research Laboratory and the Chair of the Data Safety
and Monitoring Committee
Dr. Gorlick's laboratory is interested in drug resistance
in osteosarcoma focusing on potential therapeutic targets and
mechanisms of pathogenesis with view to improving treatment
options. His clinical interests are in the care of children
and young adults afflicted with sarcomas. Since the time
of his initial ASCO awards, his research has been continuously
supported by grants from the National Cancer Institute, NIH,
the Leukemia Society of America (now called the Leukemia and
Lymphoma Society) as well as other foundations. He has
published over 100 peer-reviewed papers, book chapters and
reviews, several of which have been cited over 100 times by
others in their own research publications.
Much of Dr. Gorlick's work involves national and international
collaborations. He has held many leadership positions
in the Children's Cancer Group and Children's Oncology Group
cooperative clinical trials organizations. He was instrumental
at initiating the Children's Oncology Group's Bone Tumor Banking
Effort. At present he serves as the Vice Chair of the Bone
Tumor Disease Committee of the Children's Oncology Group. He
serves as a member of the Developmental Therapeutics Group
of the Sarcoma Alliance for Research Through Collaboration
(SARC). He serves on many advisory and editorial boards and
on review panels for the NIH and other funding entities.
Dr. Gorlick is viewed as an international leader in translational
research on osteosarcoma and he will lecture to us on, "Current
Concepts on the Molecular Biology of Osteosarcoma."
Dr. Steven Grant is associate director for translational research
and co-leader of the Cancer Cell Biology program at the Virginia
Commonwealth University Massey Cancer Center. He holds the
Shirley Carter and Sture Gordon Olson chair in oncology and
is a professor of medicine, pharmacology, biochemistry and
microbiology. Grant is an internationally recognized cancer
researcher whose work has established a new approach to cancer
treatment. Grant has demonstrated that combinations of signaling
inhibitors induce programmed cell death in cancer cells and
that blocking pathways that cancer cells use to escape treatment
causes them to activate a suicide program. His concepts are
now in Phase I clinical trials at Massey and other National
Cancer Institute-designated centers including those at Johns
Hopkins, Memorial Sloan-Kettering, and the MD Anderson Cancer
Center. His focus has been on leukemias, lymphomas and other
blood disorders, but much of his research has implications
for new treatment strategies for solid tumors as well. Grant
Joined Massey in 1988. He has had continuous funding from NCI
and other sources for more than 24 years.
Since receiving her Doctor of Osteopathy
degree from Michigan State University College of Osteopathic
Medicine, Dr. LoRusso has focused her career on cancer drug
development -- initially preclinically with a subsequent
and present focus on clinical investigation. This work
has led to successful competition, for over 14 years, as
the PI of the National Cancer Institute (NCI)-funded Phase
I U01 grant at Wayne State University/Karmanos Cancer Institute. Her
publications reflect her integral involvement in the development
of early therapeutics and include her work with many now
approved anti-cancer agents, including capecitabine, gefitinib,
zoledronic acid, lapatanib, ixabepilone, and Recentin, as
examples.
Dr. LoRusso co-chairs the NCI/CTEP Investigational Drug Steering
Committee and the Experimental Therapeutics Committee for the
Southwest Oncology Group (SWOG), and she has served on numerous
committees for the American Association of Cancer Research
(AACR), the American Society of Clinical Oncology (ASCO) and
AACR-NCI-EORTC. She has recently served as track leader
for the Clinical Trials track of the Cancer Education Committee
of the American Society of Clinical Oncology (ASCO). Having
served either ad hoc or as an appointed member on multiple
study sections in the past, including such sections as subcommittee
D of Program Projects grants, and Small Business Innovation
Research (SBIR) and Department of Defense (DOD) study sections,
she currently serves on the Clinical Oncology Subcommittee
for Quick Trials grants study section.
She has been integrally involved in cancer education, teaching
both medical and graduate students in such courses as cancer
biology, pharmacology and breast cancer, as well as internal
medicine residents and oncology fellows through rounding and
clinical hands-on experience. In addition, she has successfully
mentored junior faculty who have received such honors as NCI
peer-reviewed funding, the ASCO Young Investigator Award, as
well as mentored numerous junior clinical faculty in clinical
trial design and execution with successful LOI and protocol
submissions and acceptance. Early clinical therapeutics
and novel trial designs comprise the focus of her career objectives. In
1999, she was awarded the Hero of Breast Cancer award and in
2004 the Bennett J. Cohen Educational Leadership Award for
Medical Research.
Mace L. Rothenberg, MD, is a professor of medicine at the
Vanderbilt University Medical Center and the Ingram Professor
of Cancer Research at the Vanderbilt-Ingram Cancer Center.
A 1982 graduate of New York University School of Medicine,
Dr. Rothenberg trained as an intern and resident in internal
medicine at Vanderbilt University from 1982 to 1985. He obtained
his medical oncology training at the National Cancer Institute
(NCI) from 1985 to 1988 and served as special assistant to
the director, division of cancer treatment, from 1988 to 1991.
In 1991, he was appointed assistant professor, then associate
professor, in the department of medicine, division of medical
oncology at the University of Texas Health Science Center in
San Antonio, and executive officer of the Southwest Oncology
Group. In 1998, Dr. Rothenberg returned to Vanderbilt, where
he is currently a professor of medicine, the Ingram Professor
of Cancer Research, director of Phase I drug development, co-leader
of the experimental therapeutics orogram, and director of clinical
and translational research for the Vanderbilt SPORE in gastrointestinal
cancer.
Dr. Rothenberg is active in clinical-translational research
(supported by U01 and P50 grants from the NCI) as well as teaching
and mentoring early-career investigators (supported by a K24
grant from the NCI). He has served as an ad hoc reviewer
on several NIH study sections. He has published more than 100
articles and book chapters, primarily in the areas of early-stage
drug development, gastrointestinal malignancies and ovarian
cancer. He serves on the editorial boards of several leading
medical journals, including the Journal of Clinical Oncology, Investigational
New Drugs, Cancer Chemotherapy and Pharmacology and Clinical Colorectal
Cancer. Dr. Rothenberg’s research focuses on the evaluation of new
drugs in humans from clinical, pharmacologic, biologic and genetic perspectives.
His work was critical to the development and eventual US Food and Drug Administration
approval of irinotecan (CPT-11, Camptosar®) in 1996, oxaliplatin (Eloxatin®)
in 2002 for colorectal cancer and gemcitabine (Gemzar®) in 1996 for pancreatic
cancer.
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