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