Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis from Colon Cancer with Concomitant Systemic Oxaliplatin, Fluorouracil and Leucovorin chemotherapy, and anti-Angiogenic Therapy
PI: Robert Martin, MD, PhD
RC: Tiffany Metzger, (502) 629-3383
tiffany.metzger@louisville.edu
Pager 464-0242

Transcatheter arterial chemoembolization with doxorubicin-loaded LC beads in the treatment of liver-dominant metastases in patients with stage IV metastatic melanoma: A multi-center, non-randomized, feasibility trial
PI: Robert Martin, MD, PhD
RC: Tiffany Metzger, (502) 629-3383
tiffany.metzger@louisville.edu
Pager 464-0242
For more details, watch our stage 4 melanoma to the liver clinical trial video

A Phase III Clinical Trial to Evaluate the Safety and Efficacy of Treatment with 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects with Recurrent Metastatic Melanoma.
PI: Kelly M. McMasters, MD, PhD
RC: Debby Hulsewede, CCRC, CCRP (502) 629-3308
Deborah.hulsewede@nortonhealthcare.org
Pager 299-1301

An Open, Single-Arm Study to Assess the Clinical Activity of recMAGE-A3 + AS15 in Patients with Unresectable, MAGE-A3 Positive Metastatic Cutaneous Melanoma
PI: Kelly M. McMasters, MD, PhD
RC: Debby Hulsewede, CCRC, CCRP (502) 629-3308
Deborah.hulsewede@nortonhealthcare.org
Pager 299-1301

A Double-Blind, Randomized, Placebo-Controlled Phase III Study to Assess the Efficacy of recMAGE-A3 + AS15 ASCI as Adjuvant Therapy in Patients with Mage-A3-Positive Resected Stage III Melanoma
PI: Kelly M. McMasters, MD, PhD
RC: Debby Hulsewede, CCRC, CCRP (502) 629-3308
Deborah.hulsewede@nortonhealthcare.org
Pager 299-1301

A Phase II Study of Low Dose Hyperacute®-Pancreatic Cancer Vaccine in Subjects with Surgically Resected Pancreatic Cancer
PI: Charles Scoggins, MD, MBA
RC: Debby Hulsewede, CCRC, CCRP (502) 629-3308
Deborah.hulsewede@nortonhealthcare.org
Pager 299-1301

A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients with Operable Pancreatic Carcinoma
PI: Robert Martin, MD, PhD
RC: Susan Ellis, RN, (502) 629-3384
susan.ellis@louisville.edu
pager 478-1235

Clinical Evaluation of Neaodjuvant Gemcitabine, Docetaxel, and Capecitabine with Concurrent Radiation for Patients with Potentially Resectable Pancreatic Carcinoma
PI: Robert Martin, MD, PhD
RC: Susan Ellis, RN, (502) 629-3384
susan.ellis@louisville.edu
pager 478-1235

Clinical Evaluation of Polyflex® Stenting in Esophageal Cancer Patients undergoing Chemotherapy and/or Radiation Therapy
PI: Robert Martin, MD, PhD
RC: Susan Ellis, RN, (502) 629-3384
susan.ellis@louisville.edu
pager 478-1235

A Phase II Study of Neoadjuvant Therapy with Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients with Locall Advanced Adenocarcinoma of the Distal Esophagus
PI: Robert Martin, MD, PhD
RC: Susan Ellis, RN, (502) 629-3384
susan.ellis@louisville.edu
pager 478-1235

A Phase III Randomized, Double-Blind, Placebo-Controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma after Surgical Resection or Local Ablation
PI: Robert Martin, MD, PhD
RC: Susan Ellis, RN, (502) 629-3384
susan.ellis@louisville.edu
pager 478-1235

A Randomized Phase II Trial of Chemoradiotherapy versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head and Neck
PI: William Spanos, MD
RC: Stacy Baum, RN,
(502) 562-3429

Jeffrey Jorden, MD
Protocol C13007/ A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease
Millenium/Quintiles
12/08-12/11

Jeffrey Jorden, MD
Protocol C13008/ A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease
Millenium/Quintiles
12/08-12/11

Susan Galandiuk, MD
A randomized controlled trial to compare the functional outcome and quality of life of patients with low rectal cancer who undergo a J Pouch or a side to end coloanal anastomosis
CCF
7/09-2015

Susan Galandiuk, MD
A 5-Year, Non-Interventional Registry Study of HUMIRA® (Adalimumab) in Patients With Moderately to Severely Active Crohn’s Disease (CD)
Abbott
2/08-2015

Susan Galandiuk, MD
Abdominal Wall Component Release to Repair Complex Hernias and Enterocutaneous Fistulas in Patients at High Risk of Developing Infectious and Wound Complications
none
8/09-8/11

Susan Galandiuk, MD
Prospective open label study of a smokeless tobacco product in Crohn’s disease patients with moderate to severely active Crohn’s disease who have failed prior attempts at smoking cessation
none currently
7/06-2016

Susan Galandiuk, MD
The Association of Gastrointestinal Disease, DNA Repair, and Host Defense Genes
Ask SG
11/97-ongoing

Michael McCafferty, MD
Hereditary Colorectal Cancer Registry
none
8/08-ongoing

Clinical Trials & Registries

Evaluation of Vascutek Rapidax™ in Comparison to Vascutek MAXIFLO™ Wrap for Hemodialysis Applications - Rap-001
Principal Investigator: Amit J. Dwivedi, M.D.
Sponsor: Sulzer Vascutek
Status: enrollment completed, study closed 2009

CHOICE: Carotid Stenting for High Surgical Risk Patients: Evaluating Outcomes Through the Collection of Clinical Evidence
Principal Investigator: Charles B. Ross, M.D.
Sponsor: Abbott Laboratories
Status: Active

CABANA: Carotid Stenting Boston Scientific Surveillance Program
Principal Investigator: Charles B. Ross, M.D.
Sponsor: Boston Scientific
Status: Closed

iCAST™ Atrium Registry Ultrasound Study (iCARUS)
Principal Investigator: Charles B. Ross, M.D.
Sub-investigator: Amit J. Dwivedi, M.D.
Sponsor: Atrium Medical
Status: closed

Biomet MarrowStimTM Peripheral Arterial Disease IDE Trial
Principal Investigator: Charles B. Ross, M.D.
Sub-investigator: Amit J. Dwivedi, M.D.
Sponsor: Biomet Biologics Inc.
Status: Active

Multicenter,Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of SingleDose of PRT-201 Administered Immediately after Arteriovenous Graft Creation inPatients with Chronic Kidney Disease
PrincipalInvestigator: Amit J. Dwivedi, M.D.
Sub-investigators:Charles B. Ross, M.D. and Andrea E. Yancey, M.D.
Sponsor: Proteon Therapeutics, Inc
Status: Active

AcuteVenous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis
PrincipalInvestigator: Charles B. Ross, M.D.
Sub-investigators: Amit J. Dwivedi, M.D., Andrea E. Yancey, M.D. and Marvin E. Morris, M.D.
Sponsor: NIH, Wash U, Covidien, and Genentech
Status: In IRB review

TGIAdipose-derived Stromal Cell (ASC)-coated Peripheral Vascular Graft (PVG)
PrincipalInvestigator: Charles B. Ross, M.D.
Sub-investigators:Amit J. Dwivedi, M.D., Andrea E. Yancey, M.D. and Marvin E. Morris, M.D.
Sponsor: Tissue Genesis Inc.
Status: In IRB review

Smith, Jason
Direct Peritoneal Resuscitation Effects in the Damage Control Patient
Not funded
9/10 -

Smith, Jason
Impact of VAP diagnosis on Hospital Reimbursement
Not Funded
11/09 -

Harbrecht, Brian
Acute appendicitis in Kentucky
Not Funded
6/10 -

Harbrecht, Brian
A Prospective Study Examining Clinical Outcomes Associated with the Management of the Open Abdomen with the ABThera™ Open Abdomen Negative Pressure Therapy System and the Barker’s Vacuum Packing Technique
KCI, Inc
3/10 -

Polk, Hiram C.
SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection
NIH - University of Virginia Department of Surgery
10/08