A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III NSCLC Save

Date Added
July 18th, 2017
PRO Number
Pro00065494
Researcher
Joanna Metzner-sadurski
Keywords
Cancer, Cancer/Lung
Summary

This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib with chemoradiation therapy works in treating patients with stage III non-small cell lung cancer. Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, etoposide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving erlotinib hydrochloride is more effective than crizotinib with chemoradiation therapy in treating patients with non-small cell lung cancer.

Patients will be randomized to 1 of 4 treatment arms. After completion of study treatment, patients are followed up at 1 and 2 months, 4-6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

Circulating Tumor DNA as Liquid Biopsy in Patients with Stage IV Solid Tumors, a Feasibility Study at MUSC HCC Save

Date Added
July 13th, 2017
PRO Number
Pro00066497
Researcher
Antonio Giordano
Keywords
Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Cancer/Lymphoma, Stage IV
Summary

The overall goal of this study is to study circulating tumor DNA (ctDNA) in the blood to determine how cancer cells in patients react to treatment. DNA is short for deoxyribonucleic acid. DNA contains information that determines in part the traits, such as eye color, height, or disease risk, that are passed on from parent to child. This reaction will be measured by studying patient blood that will be collected before and during treatment until there is disease progression.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 1/2 Study on the Safety of Rovalpituzumab Tesirine Administered in Combination with Nivolumab or Nivolumab and Ipilimumab for Adults with Extensive-Stage Small Cell Lung Cancer Save

Date Added
June 27th, 2017
PRO Number
Pro00065422
Researcher
John Wrangle
Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with extensive-stage small cell lung cancer (SCLC). This study is being conducted to test whether or not rovalpituzumab tesirine (SC16LD6.5) combined with nivolumab alone or with nivolumab and ipilimumab are useful treatments for small cell lung cancer, after at least one prior treatment has failed.The investigational drugs in this study are Rovalpituzumab Tesirine (SC16LD6.5), Nivolumab (BMS-936558, MDX1106, ONO-4538, Opdivo®), and Ipilimumab (MDX-010, Yervoy®) . If participants agree to take part in this study, their involvement will last for as long as their study doctor confirms their cancer is not getting worse and there have been no significant side effects. There is no limit to the number of cycles of study treatment participants can receive.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Study to Evaluate a Panel of Blood Biomarkers for Use in Patients Undergoing Evaluation for Lung Cancer, ONC-LN-04 Save

Date Added
June 5th, 2017
PRO Number
Pro00061266
Researcher
Gerard Silvestri
Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

The primary objective of this study is to develop a blood-based gene expression signature, known as the ONC-LN-04 Lung Test, to be used in the detection of lung cancer in patients who underwent radiologic screening for lung cancer and had lung nodules detected. We intend to enroll volunteers who are being evaluated by a Medical University of South Carolina (MUSC) pulmonologist as part of their standard medical care. Participants will be current or former smokers, who have either (a) radiologic evidence of lung nodules, or (b) a confirmed diagnosis of non-small cell lung cancer (NSCLC) and has not undergone surgical excision, chemotherapy or radiation therapy for this malignancy. A single blood sample will be obtained from willing participants, then stored and analyzed for measurement of gene expression and development of the ONC-LN-04 test. Active participation in this study will be over once a blood sample is obtained; however, we may need access to participants' medical records post-enrollment and sample collection in order to monitor medical outcomes. Review of participants' medical records will occur until up to approximately 2,500 subjects have been enrolled and have provided clinical information and a blood sample.

Institution
MUSC
Recruitment Contact
Katherine Taylor
843-792-2297
taylkat@musc.edu

Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program Save

Date Added
May 1st, 2017
PRO Number
Pro00064511
Researcher
Gerard Silvestri
Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

The main objective of this study is to better understand the biomarkers of patients who are candidates for lung cancer screening. Biomarkers are biologic substances found in the blood and may be related to lung disease risk and detection. We intend to enroll volunteers who are participating in a lung cancer screening program at the Medical University of South Carolina and are being seen by a pulmonologist as part of their standard medical care. A single blood sample will be obtained, then stored and analyzed to better understand the biomarkers found in blood and to help develop and test blood based screening or diagnostic tests. Active participation in this study will be over once a blood sample is obtained. However, we may conduct medical chart reviews of some participants for up to 27 months in order to look at their medical outcomes.

Institution
MUSC
Recruitment Contact
Lindsey Owens
(843) 792-8233
owensli@musc.edu

A Multi-Center Trial of the ProLung Test™ (Transthoracic Bioconductance Measurement) as an Adjunct to CT Chest Scans for the Risk Stratification of Patients with Pulmonary Lesions Suspicious for Lung Cancer Save

Date Added
April 26th, 2017
PRO Number
Pro00062336
Researcher
Gerard Silvestri
Keywords
Cancer/Lung, Pulmonary
Summary

This study examines a new device and technology that aims to detect how likely a lung nodule or lesion is cancerous. The technology is called the ProLung Test™ and it is noninvasive and has already been been evaluated for safety. The goal of this study is to optimize and validate the test and further asses its safety and tolerability.

Institution
MUSC
Recruitment Contact
Katherine Taylor
843-792-2297
taylkat@musc.edu

Early Intrapleural TPA Instillation Versus Late (ELEVATE) Save

Date Added
February 17th, 2017
PRO Number
Pro00058518
Researcher
Rohan Arya
Keywords
Cancer/Lung, Drug Studies, Infectious Diseases, Lung, Pulmonary, Shortness of Breath
Summary

When a chest tube is placed, it can be hard for the fluid to drain. Tissue plasminogen activator and DNase are given through the chest tube to help with draining the fluid. We are doing this research to see if early addition of tPA-DNase will help with better fluid draining.

Institution
Palmetto
Recruitment Contact
Rohan Mankikar
803-352-1237
rohan.mankikar@palmettohealth.org

A Pragmatic Trial to Evaluate a Guideline-Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia ?Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) Save

Date Added
November 16th, 2016
PRO Number
Pro00061360
Researcher
James Bearden
Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Lung
Summary

Some drugs used to treat cancer raise a patient?s risk of febrile neutropenia. Febrile neutropenia is a condition that involves a fever and a low number of neutrophils (a type of white blood cell) in the blood. Having a low number of neutrophils puts a patient at risk of infection. Colony-stimulating factors (CSFs) are medications sometimes given to patients getting cancer treatment to prevent or treat febrile neutropenia. CSFs are given as an injection under the skin or into a vein.

Current guidelines say that doctors should give CSF during cancer treatment based on how likely it is that the drugs will raise the risk of febrile neutropenia. Research shows that many doctors do not follow these guidelines. This may be harming patients. Underuse of CSFs can raise a patient's risk for febrile neutropenia. Overuse or unneeded use of CSFs can lead to side effects, like bone and muscle pain, but give no benefit and can be costly to the patient.

In some clinics there is an automated system that helps doctors decide when to use CSFs. The system prescribes CSFs when there is a high risk that the drugs will cause febrile neutropenia. It does not prescribe CSFs when there is a low risk that the drugs will cause febrile neutropenia. The research study team wants to find out if this type of system can help doctors use CSF when it is needed and not use it when it is not needed. The study team also wants to learn about the benefits and risks of using CSF with cancer treatment drugs that have a moderate (not high and not low) risk of febrile neutropenia.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

A feasibility study assessing exercise level and quality of life in patients with lung cancer. Save

Date Added
August 11th, 2016
PRO Number
Pro00052856
Researcher
Gerard Silvestri
Keywords
Cancer/Lung, Exercise, Lung
Summary

Self administered-surveys will be conducted of patients with advanced stage lung cancer who utilize the Hollings Cancer Center and East Cooper multidisciplinary thoracic oncology clinic for medical care. Information about their activity level and quality of life will be collected. Baseline activity level will be monitored for one week based on amount of steps recorded on the Fitbit® pedometer, and a physical activity prescription will be given for an additional three weeks. The results will help determine if exercise is beneficial to lung cancer patients and if exercise as an adjuvant treatment is viable.

Institution
MUSC
Recruitment Contact
Katherine Taylor
843-792-2297
taylkat@musc.edu

Blood Sample Collection in Subjects with Pulmonary Nodules or CT Suspicion of Lung Cancer Save

Date Added
April 28th, 2016
PRO Number
Pro00053740
Researcher
Nichole Tanner
Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

The main objective of this study is to better understand the biomarkers of patients with abnormal CT (computed tomography) scans of the lungs. Biomarkers are biologic substances found in the blood and may be related to lung disease risk and detection. We intend to enroll volunteers with abnormal CT scans who are being evaluated by a Ralph H. Johnson VA Medical Center pulmonologist as part of their standard medical care. A single blood sample will be obtained, then stored and analyzed to better understand the biomarkers found in blood and to help develop blood-based screening or diagnostic tests. Active participation in this study will be over once a blood sample is obtained. However, we may conduct medical chart reviews of some participants for up to 27 months in order to look at their medical outcomes.

Institution
MUSC
Recruitment Contact
Lindsey Owens
(843) 792-8233
owensli@musc.edu

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