Repetitive transcranial magnetic stimulation for smoking cessation in cancer patients Save

Date Added
September 5th, 2017
PRO Number
Pro00066330
Researcher
Xingbao Li
Keywords
Brain, Cancer, Smoking
Summary

Cigarette smoking is a significant public health concern especially in cancer patients. rTMS has been investigated for smoking cessation in healthy smokers. This study will test the therapeutic benefits of rTMS for smoking cessation in cancer patients with smoking. Firstly, we will evaluate total number of smoke-free days during a 7-day quit attempt. Secondly, we will evaluate cigarette consumption and cue craving for smoking during the quit attempt period.

Institution
MUSC
Recruitment Contact
Xingbao Li
843-792-5729
lixi@musc.edu

Phase Ib/II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies Save

Date Added
August 22nd, 2017
PRO Number
Pro00066806
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Brain Tumor, Cancer, Cancer/Brain
Summary

This study is for patients that have been diagnosed with Central Nervous System (CNS) Tumors. The investigational drugs in this study are Nivolumab and Ipilimumab. The purpose of this study is to test the effectiveness, safety, and tolerability of Nivolumab when given alone or when combined with Ipilimumab. The duration of patient participation may be more than 3 years. If enrolled in treatment, the exact length of time will depend on the patients response to treatment.

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

QUILT-3.055: A Phase IIb, Single-Arm, Open-Label Study of ALT-803 in Combination with Pembrolizumab or Nivolumab in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer who have Disease Progression Following an Initial Response to Treatment with PD-1 Checkpoint Inhibitor Therapy Save

Date Added
August 22nd, 2017
PRO Number
Pro00068710
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 advanced or metastatic non-small cell lung cancer (NSCLC) whose disease improved or remained unchanged after receiving nivolumab or pembrolizumab and whose disease has now worsened. The investigational drug in this study is called ALT-803. Participants can expect to receive the study drug ALT-803 in combination with an approved drug called pembrolizumab or they will receive ALT-803 in combination with an approved drug called nivolumab. Participants will receive ALT-803 in combination with pembrolizumab if they have previously received pembrolizumab. They will receive ALT-803 in combination with nivolumab if they have previously received nivolumab. The purpose of this research study is to test the effectiveness of the study drug, ALT-803, in combination with either pembrolizumab or nivolumab in patients with advanced or metastatic NSCLC that initially had improvement or no change in disease after receiving pembrolizumab or nivolumab and who now have disease worsening. Participation in this study should take approximately 24 months.

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

Validation of the Palliative Performance Scale to predict survival of older adults admitted to the hospital from the Emergency Department. Save

Date Added
August 4th, 2017
PRO Number
Pro00063739
Researcher
Leigh Vaughan
Keywords
Cancer, Dementia, Heart, Kidney, Liver, Pulmonary, Stroke
Summary

The Palliative Performance Scale has been shown to predict survival among hospice and palliative medicine patients in the outpatient and inpatient clinical settings, where lower PPS scores are directly related to shorter survival. We seek to evaluate if this relationship persists among a racially diverse, older adult population when assessed at the time of admission from the emergency department.

Institution
MUSC
Recruitment Contact
Jonas Te Paske
8432597649
tepaske@musc.edu

A multicenter, multinational, randomized, double-blind, pharmacokinetic and pharmacodynamic (PK/PD) dose-finding study of oral netupitant administered concomitantly with oral palonosetron in pediatric cancer patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy. Save

Date Added
July 25th, 2017
PRO Number
Pro00067181
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for pediatric patients that have been diagnosed with cancer and are receiving chemotherapy. The investigational drugs in this study are netupitant and palonosetron. The purpose of this study is to learn more about how well the combination of oral netupitant and oral palonosetron works in preventing nausea and vomiting associated with chemotherapy in children. Participation in the study will last for a maximum of 31 days, which includes a screening period up to 14 days before randomization (up to 7 days for patients aged less than 2 years), the day of enrollment/randomization, administration of study drugs and chemotherapy (Study Day 1), and the control visits (Study Days 2 to 5).

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

A Phase I open label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of ONO-7475 in patients with acute leukemias Save

Date Added
July 25th, 2017
PRO Number
Pro00068834
Researcher
Juan Varela
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with a type of cancer called Acute Myeloid Leukemia (AML). The investigational drug in this study is ONO-7475. The purpose of this study is to see whether ONO-7475 slows down the growth of cells that cause cancers like leukemias such as AML. The estimated duration of study participation in Part A is 6 months. You can continue in the study as long as you are gaining benefit from the study treatment.

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

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

A Phase 3 Randomized, Open-Label Study Comparing Pexa-Vec (Vaccinia GM-CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy Save

Date Added
June 27th, 2017
PRO Number
Pro00066060
Researcher
Juan Camacho
Keywords
Cancer, Cancer/Gastrointestinal, Liver, Men's Health, Vaccine, Women's Health
Summary

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy

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

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

Date Added
June 5th, 2017
PRO Number
Pro00064384
Researcher
Nichole Tanner
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 Ralph H. Johnson VA Medical Center 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

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