12 results match your criteria: "University of Louisville-James Graham Brown Cancer Center[Affiliation]"
Benefit of Avasopasem Manganese on Severe Oral Mucositis in Head and Neck Cancer in the ROMAN Trial: Unplanned Secondary Analysis.
Adv Radiat Oncol
January 2025
International Drug Development Institute (IDDI), Louvain-la-Neuve, Belgium.
Purpose: Oral mucositis (OM) is a debilitating side effect of cisplatin and intensity-modulated radiation therapy (IMRT) in patients with head and neck cancer. The phase 3 ROMAN trial showed avasopasem manganese (AVA) significantly decreased individual endpoints of incidence and duration of severe oral mucositis (SOM, World Health Organization [WHO] grade 3-4), with nominal decrease in severity (WHO grade 4) and significant increase in the delay in onset of SOM. We sought to determine the Net Treatment Benefit (NTB) of AVA versus placebo (PBO) using the generalized pairwise comparisons (GPC) method.
View Article and Find Full Text PDFTwo-Year Tumor Outcomes of a Phase 2B, Randomized, Double-Blind Trial of Avasopasem Manganese (GC4419) Versus Placebo to Reduce Severe Oral Mucositis Owing to Concurrent Radiation Therapy and Cisplatin for Head and Neck Cancer.
Int J Radiat Oncol Biol Phys
November 2022
Clinical Development, Primary Endpoint Solutions, Waltham, Massachusetts.
Purpose: Avasopasem manganese (GC4419), an investigational selective dismutase mimetic radioprotector, reduced duration, incidence, and severity of severe oral mucositis (World Health Organization grade 3-4) in a phase 2b, randomized, double-blind trial of patients receiving concurrent cisplatin (cis) and radiation therapy (RT) for head and neck cancer. We report the secondary endpoints of final 1- and 2-year tumor outcomes and exploratory data on trismus and xerostomia.
Methods And Materials: Patients with locally advanced oral cavity or oropharynx cancer to be treated with definitive or postop cis and RT were randomized to 1 of 3 arms: 30 mg avasopasem, 90 mg avasopasem, or placebo.
Assessment of hospitalization rates for immune-related adverse events with immune checkpoint inhibitors.
J Oncol Pharm Pract
October 2021
Department of Pharmacy, University of Louisville Hospital, Louisville, KY, USA.
Introduction: Immune checkpoint inhibitors (ICIs) have become the standard of care in many cancer types. As the number of patients receiving ICIs for various cancers continues to expand, patients and practitioners should be aware of potentially severe immune-related adverse events (irAEs). Despite reports of the incidence of grade 3/4 toxicities, the proportion of patients whose symptoms were clinically severe enough to warrant hospitalization for adverse event management is unknown.
View Article and Find Full Text PDFVascular Access Device Care and Management: A Comprehensive Organizational Approach.
J Infus Nurs
June 2021
Duke University School of Nursing, Durham, North Carolina (Dr Meyer); Infusion Nurses Society, Norwood, Massachusetts (Dr Berndt); VA Medical Center, Albany, New York (Ms Biscossi); Houston Baptist University, Houston, Texas (Dr Eld); Rutland Regional Medical Center, Rutland, Vermont (Ms Gillette-Kent); University of Louisville James Graham Brown Cancer Center, Louisville, Kentucky; University of Louisville School of Nursing, Louisville, Kentucky (Dr Malone); New York Presbyterian Brooklyn Methodist Hospital, New York, New York (Dr Wuerz). Britt M. Meyer, PhD, RN, CRNI®, VA-BC, NE-BC, is a Duke University School of Nursing quality implementation scholar who provides leadership for vascular access and infusion practices at Duke University Health System. She leads the 55-member vascular access team at Duke University Hospital and is widely published on vascular access and infusion topics. Dr Meyer is currently involved in a variety of research projects aimed at improving patient outcomes related to vascular access and infusion therapy. She presents nationally and internationally to disseminate emerging evidence and promote translation of evidence into practice. Dawn Berndt, DNP, RN, CRNI®, is the Clinical Education and Publications Manager for Infusion Nurses Society (INS). She has been an active INS member and a CRNI® since 2005. She served on INS' National Council on Education from 2011 to 2014 and on INS' Board of Directors as a director-at-large from 2017 to 2018. Prior to joining the INS team, Dawn worked for 13 years as a clinical nurse specialist for infusion and as nurse manager of the infusion center, the venous access team, and the RN response team at the University of Wisconsin Health-University Hospital. Michele Biscossi, MS, RN, ACNP-BC, CNL, VA-BC, is an acute care nurse practitioner and a clinical nurse leader within surgical service and interventional radiology and vascular access at the Albany Stratton VA Medical Center in Albany, New York. She is twice master's prepared in nursing education and as a clinical nurse specialist in critical care. Ms Biscossi has worked as adjunct nursing faculty at Excelsior College in Albany, NY, and at the Sage Colleges in Troy, NY. She is widely published on vascular access and infusion therapy as well as pain management and venous thromboembolic prevention and treatment in international peer-reviewed journals. She is an active member of AVA and INS and has served on the National Board of Directors for AVA, The AVA Foundation, and INS' National Council on Education. She is one of the original co-authors of the Vascular Access Certification Exam Review Guide for AVA and is three times nationally board certified. Ms Biscossi presents nationally and internationally to disseminate emerging evidence and promote translation of evidence into practice. Melanie Eld, PhD, RN, is a nurse leader with 11 years of experience in clinical education. She has served in various academic, management, and administration positions and as a consultant to frontline clinicians and managers. Dr Eld's clinical background is in hematopoietic progenitor stem cell transplant, hematology, and infusion. Currently, she is a professor in the School of Nursing and Allied Health at Houston Baptist University, teaching courses in patho-pharmacology and nursing research. Ginger Gillette-Kent, MSN, MBA, RN, APRN, ANP-BC, NEA-BC, is a nurse practitioner with 14 years of experience in a variety of areas, including 5 years in leadership, infusion, diagnostic imaging, and interventional radiology. Currently, Ms Gillette-Kent works as a manager of nursing at Rutland Regional Medical Center and screens patients for lung cancer. She is focused on defeating the concept "because we've always done it that way" and embracing evidence-based medicine. Angie Malone, DNP, APRN, ACNS-BC, OCN, AOCNS, is an oncology clinical nurse specialist with 18 years of experience in oncology, palliative care, and vascular access. She is the director of medical oncology and infusion services at University of Louisville James Graham Brown Cancer Center. Dr Malone seeks innovative ways to improve operations, nursing practice, and the patient experience in the oncology setting. Currently, Dr Malone serves as faculty and teaches evidence-based practice courses at University of Louisville School of Nursing DNP program. She has presented on a myriad of topics in oncology, vascular access, and evidence-based practice. Lorelle Wuerz, PhD, MSN, RN, VA-BC, NEA-BC, is a nursing leader with 15 years of experience managing medical-surgical, labor and delivery, recovery, postpartum, critical care, surgical, trauma, and transplant services. She is currently the director of nursing for practice, quality, and professional development at New York Presbyterian Brooklyn Methodist Hospital. Dr Wuerz speaks nationally on various topics in nursing and has authored several manuscripts on nursing leadership, professionalism, and vascular access-related topics.
The Infusion Nurses Society asserts that a comprehensive organizational approach to vascular access device (VAD) care and management is imperative to ensure safe and efficacious patient care. It is essential that each organization (1) develops policies and procedures to align VAD care and management with recognized standards of practice; (2) integrates unique aspects of organization-selected VAD care products into policies and procedures and establishes expectations for adherence to these organizational directives; (3) develops a framework for gathering and analyzing clinical data related to patient outcomes for VAD care and management; (4) utilizes quality outcome data to facilitate evidence-based best practices within the organization; and (5) evaluates and facilitates educational programming to validate clinician competency.
View Article and Find Full Text PDFPurpose: Oral mucositis (OM) remains a common, debilitating toxicity of radiation therapy (RT) for head and neck cancer. The goal of this phase IIb, multi-institutional, randomized, double-blind trial was to compare the efficacy and safety of GC4419, a superoxide dismutase mimetic, with placebo to reduce the duration, incidence, and severity of severe OM (SOM).
Patients And Methods: A total of 223 patients (from 44 institutions) with locally advanced oral cavity or oropharynx cancer planned to be treated with definitive or postoperative intensity-modulated RT (IMRT; 60 to 72 Gy [≥ 50 Gy to two or more oral sites]) plus cisplatin (weekly or every 3 weeks) were randomly assigned to receive 30 mg (n = 73) or 90 mg (n = 76) of GC4419 or to receive placebo (n = 74) by 60-minute intravenous administration before each IMRT fraction.
Purpose: Retrospective studies suggest that it may be safe to extend the maintenance flushing interval of implanted ports from once every month, as recommended by the manufacturer, to once every 3 months, but no prospective cohort studies have been done specifically assessing the safety and feasibility of this intervention.
Methods: This was a phase II study in oncologic patients who retained a functional port after completion of systemic chemotherapy. Patients enrolled in the study had their port flushed once every 3 months and were observed until completion of five scheduled flushes (one on enrollment and four additional flushes, one every 3 months) or development of any port-related complication, including infections, thrombosis, and occlusions.
Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Accelerated Radiation Plus Cisplatin With or Without Cetuximab for Locally Advanced Head and Neck Carcinoma: NRG Oncology Radiation Therapy Oncology Group 0522.
Int J Radiat Oncol Biol Phys
March 2017
Emory University, Atlanta, GA.
Purpose: To analyze the quality of life (QOL) and performance status (PS) (secondary outcome) in patients with stage III to IV head and neck cancer (HNC) enrolled on a prospective randomized phase 3 trial comparing radiation-cisplatin without cetuximab (CIS) or with cetuximab (CET/CIS). The QOL hypothesis proposed a between-arm difference in Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) total score of ≥10% of the instrument range from baseline to 1 year.
Methods And Materials: Patients who gave consent to the QOL/PS study completed the FACT-HN, Performance Status Scale for HNC (PSS-HN), and EuroQol (EQ-5D) at baseline through to 5 years.
Griffithsin-Modified Electrospun Fibers as a Delivery Scaffold To Prevent HIV Infection.
Antimicrob Agents Chemother
November 2016
Department of Bioengineering, University of Louisville, Louisville, Kentucky, USA
Despite current prophylactic strategies, sexually transmitted infections (STIs) remain significant contributors to global health challenges, spurring the development of new multipurpose delivery technologies to protect individuals from and treat virus infections. However, there are few methods currently available to prevent and no method to date that cures human immunodeficiency virus (HIV) infection or combinations of STIs. While current oral and topical preexposure prophylaxes have protected against HIV infection, they have primarily relied on antiretrovirals (ARVs) to inhibit infection.
View Article and Find Full Text PDFFacile Method for the Production of Recombinant Cholera Toxin B Subunit in E. coli.
Methods Mol Biol
December 2016
Owensboro Cancer Research Program, University of Louisville James Graham Brown Cancer Center, 1020 Breckenridge Street Suite 201, Owensboro, KY, 42303, USA.
Herein, we report an Escherichia coli-based expression and purification method of recombinant cholera toxin B subunit (CTB). The CTB gene (E. coli codon optimized) is cloned into commercial pET-22b(+) vector using standard molecular biology techniques and the resulting vector is transformed into BL21(DE3) electrocompetent cells.
View Article and Find Full Text PDFMapping the CgrA regulon of Rhodospirillum centenum reveals a hierarchal network controlling Gram-negative cyst development.
BMC Genomics
December 2015
Molecular and Cellular Biochemistry Department, Indiana University, Bloomington, IN, 47405, USA.
Background: Several Gram-negative species undergo development leading to the formation of metabolically dormant desiccation resistant cysts. Recent analysis of cyst development has revealed that ~20 % of the Rhodospirillum centenum transcriptome undergo temporal changes in expression as cells transition from vegetative to cyst forms. It has also been established that one trigger for cyst formation is the synthesis of the signaling nucleotide 3', 5'- cyclic guanosine monophosphate (cGMP) that is sensed by a homolog of the catabolite repressor protein called CgrA.
View Article and Find Full Text PDFEfficacy of concurrent chemoradiotherapy for patients with locally recurrent or advanced inoperable breast cancer.
Clin Breast Cancer
April 2015
Department of Radiation Oncology, University of Louisville James Graham Brown Cancer Center, Louisville, KY.
Background: This study aimed to assess the efficacy and safety of chemoradiotherapy (CRT) for locally recurrent or advanced inoperable breast cancer.
Patients And Methods: Twenty patients treated between 2009 and 2013 were reviewed from a prospectively collected database. All patients had symptomatic recurrent or advanced breast cancer and had been deemed not to be ideal operative candidates.
Neoadjuvant chemoradiation for extrahepatic cholangiocarcinoma.
Am J Surg
December 1997
Division of Surgical Oncology, University of Louisville-James Graham Brown Cancer Center, Kentucky 40202, USA.
Background: The prognosis for patients with extrahepatic bile duct cancer remains poor. The purpose of this study was to evaluate our initial results with preoperative chemoradiation for extrahepatic cholangiocarcinoma, in the context of our experience with conventional treatment of this disease over the past 13 years.
Methods: From 1983 through 1996, analysis of all patients treated for extrahepatic cholangiocarcinoma was performed.