south carolina commission on higher education october 6, 2011
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South Carolina Commission on Higher Education October 6, 2011. Melanie Thomas, M.D., M.S. Associate Professor of Medicine Medical University of South Carolina Associate Director of Clinical Investigations Hollings Cancer Center Grace E. DeWolff Chair in Medical Oncology - PowerPoint PPT PresentationTRANSCRIPT
South Carolina Commission on Higher EducationOctober 6, 2011
South Carolina Commission on Higher EducationOctober 6, 2011
Melanie Thomas, M.D., M.S.
Associate Professor of Medicine Medical University of South Carolina
Associate Director of Clinical Investigations Hollings Cancer Center
Grace E. DeWolff Chair in Medical Oncology
Gastrointestinal Cancer Diagnostics Center of Economic Excellence
Melanie Thomas, M.D., M.S.
Associate Professor of Medicine Medical University of South Carolina
Associate Director of Clinical Investigations Hollings Cancer Center
Grace E. DeWolff Chair in Medical Oncology
Gastrointestinal Cancer Diagnostics Center of Economic Excellence
Melanie B. Thomas, M.D.SmartState Endowed Chair –
Gastrointestinal Cancer DiagnosticsEducation and Background
Melanie B. Thomas, M.D.SmartState Endowed Chair –
Gastrointestinal Cancer DiagnosticsEducation and Background
Undergraduate Education Boston College, BA Biology
Graduate Education Harvard University, MS Engineering
Medical School Boston University School of Medicine
Residency, Internal MedicineBeth Israel Deaconess Medical CenterHarvard Medical School, Boston, MA
Fellowship, Medical Oncology University of Texas M.D. Anderson Cancer Center
Faculty - Department of Gastrointestinal Medical Oncology 2002-2008
University of Texas M.D. Anderson Cancer Center
August 2008-present MUSC-Hollings Cancer CenterAssociate Director of Clinical InvestigationsAssociate Professor of Medicine
National Cancer Institute Designation for Hollings Cancer Center
National Cancer Institute Designation for Hollings Cancer Center
• May 1, 2008, I signed offer letter to join MUSC-HCC as Associate Director of Clinical Investigations on August 1.
• May 20, 2008 Core Grant Application submitted to NCI.
• September 2008 NCI Site Visit, Charleston.
• Responsible for Hollings Cancer Center Protocol Review and Monitoring System (PRMS), clinical trial accrual, quality.
• December 2008 - Conditional approval received, citing 7 issues requiring response.
• Resubmission December 2010 after extensive improvements.
• Full approval of PRMS with laudatory comments January 2011.
• May 1, 2008, I signed offer letter to join MUSC-HCC as Associate Director of Clinical Investigations on August 1.
• May 20, 2008 Core Grant Application submitted to NCI.
• September 2008 NCI Site Visit, Charleston.
• Responsible for Hollings Cancer Center Protocol Review and Monitoring System (PRMS), clinical trial accrual, quality.
• December 2008 - Conditional approval received, citing 7 issues requiring response.
• Resubmission December 2010 after extensive improvements.
• Full approval of PRMS with laudatory comments January 2011.
Gastrointestinal (GI) Cancers in SCGastrointestinal (GI) Cancers in SC
• Two of every 5 South Carolinians will develop cancer in their lifetime.
• SC ranks slightly higher than the US average for cancer incidence (new cases per 100,000) and mortality.
• Cancers of the Gastrointestinal tract include:
• Esophagus, stomach, small intestine, pancreas, liver, gallbladder, bile ducts, colorectal.
• Cancer Registry data (1996-2001) GI cancers comprise 37% of all cancers in SC.
• SC ranks 26th in the U.S. in colorectal cancer mortality.
• Cancers of the liver and bile ducts are the fastest rising cancers in SC:
• Annual increase 9.5% incidence, 2.2% mortality (similar to U.S.)
• AA (men>women) with pancreatic, colorectal cancer, have worse outcome compared to Caucasians.
• Two of every 5 South Carolinians will develop cancer in their lifetime.
• SC ranks slightly higher than the US average for cancer incidence (new cases per 100,000) and mortality.
• Cancers of the Gastrointestinal tract include:
• Esophagus, stomach, small intestine, pancreas, liver, gallbladder, bile ducts, colorectal.
• Cancer Registry data (1996-2001) GI cancers comprise 37% of all cancers in SC.
• SC ranks 26th in the U.S. in colorectal cancer mortality.
• Cancers of the liver and bile ducts are the fastest rising cancers in SC:
• Annual increase 9.5% incidence, 2.2% mortality (similar to U.S.)
• AA (men>women) with pancreatic, colorectal cancer, have worse outcome compared to Caucasians.
GI Cancers at Hollings Cancer Center
GI Cancers at Hollings Cancer Center
Cancer Type Number New Patients 2010
GIGI 390390
ThoracicThoracic 324324
GUGU 314314
Head & NeckHead & Neck 267267
MelanomaMelanoma 233233
BreastBreast 215215
Heme/BMTHeme/BMT 160160
GynGyn 136136
NeuroNeuro 7272
SarcomaSarcoma 4848
PediatricPediatric 4141
TotalTotal 22072207
Gastrointestinal Cancers
represent 18% of all tumor
types seen at HCC in 2010
Multidisciplinary Management of GI Cancers at MUSC
Multidisciplinary Management of GI Cancers at MUSC
• Patients benefit from comprehensive, multidisciplinary, integrated cancer care:
• Digestive Disease Center nationally renowned, regional referral center.
• Only liver transplantation program in SC.
• 2 GI surgical oncologists trained at M.D. Anderson Cancer Center.
• Interventional Radiology program offers therapeutic options not available elsewhere in SC.
• Weekly Tumor Boards in GI cancers, Liver Tumors
• Currently have 11 clinical trials active for GI cancer patients.
• Patients benefit from comprehensive, multidisciplinary, integrated cancer care:
• Digestive Disease Center nationally renowned, regional referral center.
• Only liver transplantation program in SC.
• 2 GI surgical oncologists trained at M.D. Anderson Cancer Center.
• Interventional Radiology program offers therapeutic options not available elsewhere in SC.
• Weekly Tumor Boards in GI cancers, Liver Tumors
• Currently have 11 clinical trials active for GI cancer patients.
SmartState Collaborations in GI Cancers:SmartState Collaborations in GI Cancers:
Kenneth Tew, PhDTranslational Cancer Therapeutics
Kenneth Tew, PhDTranslational Cancer Therapeutics
Charles D. Smith, PhDCancer Drug DiscoveryCharles D. Smith, PhDCancer Drug Discovery
John J. LeMasters, PhDCancer Drug DiscoveryJohn J. LeMasters, PhDCancer Drug Discovery
MUSC GI Cancers Research ProgramMUSC GI Cancers Research Program
Zihai Li, M.D.Cancer Stem Cell Biology
Zihai Li, M.D.Cancer Stem Cell Biology
Developed pilot study of novel cancer vaccine for pancreatic cancer patients.Developed pilot study of novel cancer vaccine for pancreatic cancer patients.
Co-developed Biomarker Retreat tobuild a biomarker discovery program in clinical cancer research
Co-developed Biomarker Retreat tobuild a biomarker discovery program in clinical cancer research
•Designed and activated a Phase I, First in Humans, first in class clinical trial of ABC 294640, novel drug developed by Dr. Smith and MUSC.
•Have co-written numerous NIH, MUSC Grant Applications.
•Designed and activated a Phase I, First in Humans, first in class clinical trial of ABC 294640, novel drug developed by Dr. Smith and MUSC.
•Have co-written numerous NIH, MUSC Grant Applications.
Studies effects of hypoxic and other injuries to liver cells, with liver transplant program.
Studies effects of hypoxic and other injuries to liver cells, with liver transplant program.
New Clinical Trials forGI Cancer Patients
Hollings Cancer Center 2008-2011
New Clinical Trials forGI Cancer Patients
Hollings Cancer Center 2008-2011
Study Contract ValueAn Open-Label, Multi-Center, Randomized Placebo-Controlled Phase II Study of Regorafenib in Combination with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) versus Placebo and FOLFIRI as Second Line Therapy in Patients with K-RAS or BRAF Mutant Metastatic Colorectal Cancer
$118,000.00$118,000.00
A Randomized Open-Label Multi-Institution Phase II Study of the Combination of Bevacizumab and Erlotinib Compared to Sorafenib in the First-Line Treatment of Patients with Advanced Hepatocellular Carcinoma (HCC)
$3,419,511.00$3,419,511.00
A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Follow by Concurrent Capectiabine and Radiotherapy in Extrahepatic Cholangiocarcinoma $12,000.00$12,000.00
Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of mFOLFOX6 Chemotherapy Plus Ramucirumab Drug Product (IMC-1121B) versus mFOLFOX6 Plus Placebo for Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, or Stomach
$181,273.00$181,273.00
A Phase I Pharmacokinetic and Pharmacodynamic Study of PF-03446962 in Patients with Advanced Solid Tumors - Hepatocellular Carcinoma $144,400.00$144,400.00An Open-Label, Multicenter, Randomized, Phase 3 Study of S-1 and Cisplatin Compared with 5-FU and Cisplatin in Patients with Metastatic Diffuse Gastric Cancer Previously Untreated with Chemotherapy
$79,303.00$79,303.00
A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy
$229,270.00$229,270.00
New Clinical Trials for GI Cancer Patients
Hollings Cancer Center 2008-2011
New Clinical Trials for GI Cancer Patients
Hollings Cancer Center 2008-2011
Study Contract ValueA Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas
$136,646.00$136,646.00
A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma $20,000.00$20,000.00
Phase 3 Prospective, Randomized, Blinded and Controlled Investigation of HEPASPHERE/QUADRASPHERE MICROSPHERES for Delivery of Doxorubicin DOXORUBICIN for the Treatment of Hepatocellular Cancer
$153,180.00$153,180.00
TOTAL $4,493,583.00
A Feasibility and Safety Study of Vaccination with Poly-ICLC and Peptide-pulsed Dendritic Cells in Patients with Metastatic Pancreatic Adenocarcinoma
$125,000.00$125,000.00(HCC Translational Research Pilot (HCC Translational Research Pilot Funds)Funds)
A Phase I, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of ABC294640 in Patients with Advanced Solid Tumors
$75,000$75,000(HCC Translational Research Pilot (HCC Translational Research Pilot Funds)Funds)
GI Cancer Research Future Initiatives
GI Cancer Research Future Initiatives
Study Comments/Funding
Prospective Study of Biomarkers to Evaluate Racial Differences in Outcome for Subjects Treated for Advanced Colorectal Cancer Investigator-initiated trial
A Phase II Trial of Neoadjuvant FOLFIRINOX Chemotherapy with or without Chemoradiation in the Treatment of Patients with Frankly Resectable or Borderline Resectable Pancreatic Cancer
Investigator-initiated trial
A Phase II Trial of Gemcitabine and Albumin-bound Paclitaxel with or without Chemoradiation in Patients with Locally-Advanced Adenocarcinoma of the Pancreas.
Investigator-initiated trial
Phase II Study of Hepatic Arterial Infusion (HAI) of Chemotherapy in Patients with Liver-dominant metastases from Adenocarcinoma of the Pancreas, Gallbladder, Bile Ducts, Small Intestine.
Collaboration with M.D. Anderson Cancer Center
Pancreatic Tissue Specimen Acquisition for ResearchHCC Translational Research Pilot FundingFunding from Talbot Family Foundation
Phase I Study f Crizotinib in Hepatic Dysfunction Pfizer, Inc.
South Carolina Commission on Higher EducationOctober 6, 2011
South Carolina Commission on Higher EducationOctober 6, 2011
Questions?
Gastrointestinal Cancer Diagnostics Center of Economic Excellence
Questions?
Gastrointestinal Cancer Diagnostics Center of Economic Excellence