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Clinical Trials

List of Investigators

Kelly M. McMasters, MD, PhD
Anees B. Chagpar, MD
Glen A. Franklin, MD
Susan Galandiuk, MD
Richard E. Goldstein, MD, PhD
Charles R. Scoggins, MD

 
 

Kelly M. McMasters, MD, PhD

http://www.aboutlivertumors.com
http://www.aboutlivertumors.com
http://www.aboutbreasthealth.com/clinicaltrials.aspx
 http://www.louisvillesurgonc.com/clinical.html

Schering-Oncology Biotech

Sunbelt Melanoma Trial 

Southwestern Oncology Group

Phase III Randomized Study of Four Weeks of High Dose IFN-˙2b in Stage T3 – T4 or N1 (microscopic) Melanoma 

A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients with “No Evidence of Disease” after Complete Surgical Resection of “Locally Advanced” and/or Stage IV Melanoma

AVAX

M-Vax: A Feasibility and Bio-Equivalence Study Using a DNP-Modified Autologous Melanoma Tumor Cell Vaccine as Therapy in Patients with Stage III or IV Melanoma

Comparison of M-Vax Plus Low Dose Interleukin-2 versus Placebo Vaccine plus Low-Dose Interleukin-2 Paitents with Stage IV Melanoma

John Wayne Cancer Institute

Multicenter Selective Lymphadenectomy for Melanoma Trial II: A Phase III Multicenter Randomized Trial of Sentinel Lymphadenectomy and Complete Lymph Node Dissection versus Sentinel Lymphadenectomy Alone in Cutaneous Melanoma Patients with Molecular or Histopathological Evidence of Metastases in the Sentinel Node

Prospective Study of the Natural History of Subjects Who Were Entered in the MMAIT-03-001 and MMAIT-04-001 Trials and Underwent Post-Operative Therapy with BCG Plus Placebo or BCG plus Canvaxin

VICAL

A Phase III Clinical Trial to Evaluate the Safety and Efficacy of Treatment with 2 mg Intralesional Allovectin-7 Compared to DTIC or TMZ in Subjects with Recurrent Metastatic Melanoma

Veridex, LLC

Identification of Gene Markers to Differentiate Benign and Malignant Melanocytic Skin Lesions

 

Anees B. Chagpar, MD

http://www.aboutbreasthealth.com/clinicaltrials.aspx

University of Louisville, Departments of Anesthesiology & Surgery

Regional Anesthesia and Breast Cancer (Investigator-Initiated)

University of Louisville, Department of Surgery

Patient Satisfaction and Quality of Life: University Surgical Associates

Breast Clinic (Investigator-Initiated) 13 3

University of Louisville, Departments of Chemistry & Surgery

Biomarker Development for Environmental Impact on Breast Carcinogenesis (Investigator-Initiated)

National Cancer Institute of Canada (NCIC)

MA.27: A Randomized, Phase III Trial of Exemestane vs. Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer

MA.27B: The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density in Postmenopausal Women with Primary Breast Cancer: A Companion Study to MA.27

MA.27D: The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to MA.27

National Surgical Adjuvant Breast and Bowel Project (NSABP)

B-42: A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer

B-35: A Clinical Trial Comparing Anastrozole with Tamoxifen in Postmenopausal Patients with Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy with Radiation Therapy

ACOSOG

Z0011: A Randomized Trial of Axillary node Dissection in Women with Clinical T1 or T2N0M0 Breast Cancer who have a Positive Sentinel Node

Veridex, LLC

Beta Study: GeneSearch Breast Lymph Node (BLN) Assay for Intra-Operative Molecular Testing

Pivotal Study: GeneSearch Breast Lymph Node (BLN) Assay for Intra-Operative Molecular Testing

IMI, International Medical Innovations, Inc.

Detection of Malignancy in Nipple Aspirate Fluid Using a Quantitative Galactose Oxidase- Schiff’s Reaction

Glen A. Franklin, MD

http://www.uoflhealthcare.org/Default.aspx?tabid=504

Novo Nordisk, Inc.

A multi-center, randomized, double-blind, parallel group, placebo controlledtrial to evaluate the efficacy and safety of activated recombinant factor VII (rFVIIa/NovoSeven®/NiaStase®) in the treatment of refractory bleeding inseverely injured trauma patients

Cadence Pharmaceuticals

A Phase III, multi-center, randomized, evaluation committee-blinded study to assess the efficacy of topical administration of omiganan 1.0% gel in preventing local catheter site infections and catheter colonization in patients undergoing central venous catheterization

Eisai Pharmaceuticals

A controlled comparison of eritoran tetrasodium and placebo in patients with severe sepsis

Susan Galandiuk, MD

http://www.priceinstitute.com/grants/trials.html
http://www.uoflhealthcare.org/Default.aspx?tabid=504

Abbott Pharmaceutical, Inc.

A 5-Year, Non-Interventional Registry Study of HUMIRA® (Adalimumab)in Patients with Moderately to Severely Active Crohn’s Disease (CD) (08.0096)

Quintiles

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to SeverelyActive Ulcerative Colitis (07.0085)

Galandiuk Protocol

The Association of Gastrointestinal Disease, DNA Repair, and Host Defense Genes (361.97)

Galandiuk Protocol

Prospective open label study of a smokeless tobacco product in Crohn’s disease patients with moderately to severely active Crohn’s disease who have failed prior attempts at smoking cessation (323.06)

Pacira Pharmaceutical, Inc.

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects

 

Richard E. Goldstein, MD, PhD

http://www.louisvillesurgonc.com/clinical.html

Pfizer

A Pivotal Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 in Patients with 131I-refractory Metastatic or Unresectable Locally-advanced Papillary, Follicular, or Hurthle-cell Thyroid Cancer Who are also Refractory to, or Intolerant of, or have Clinical Contraindication to, Doxorubicin Treatment

 

Charles R. Scoggins, MD

http://www.louisvillesurgonc.com/clinicalGIST.html
http://www.aboutbreasthealth.com/clinicaltrials.aspx

 

American College of Surgeons Oncology Group

A Phase III Randomized Double-blind Study of Adjuvant STI571 (GleevecTM) Versus Placebo in Patients Following The Resection of Primary GastroIntestinal Stromal Tumor (GIST):   

 

Novartis

Gastrointestinal Stromal Tumors (GIST) Registry 

Neoprobe

Phase II, Single Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Lymphoseek as a Lymphoid Tissue Targeting Agent in Patients with Known or Suspected Melanoma or Breast Cancer Who are Undergoing Lymph Node Mapping