A Randomized Phase II Study of Tepotinib with or without Ramucirumab in Participants with MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

Date Added
November 7th, 2024
PRO Number
Pro00140795
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer/Lung
Summary

This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.

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

Impacts of drug abuse-mediated inflammatory perturbations on affinity maturation of anti-CD4 autoantibodies and poor immune reconstitution from ART in HIV

Date Added
November 6th, 2024
PRO Number
Pro00140552
Researcher
Wei Jiang

List of Studies


Keywords
Drug Studies, HIV / AIDS
Summary

This study is to understand HIV-infected cocaine users have poor immunity after anti-HIV treatment, but HIV-infected cannabis users are likely different. Cocaine use always is associated high inflammation and cannabis use is associated with low inflammation. We study how inflammation cannot be controlled in cocaine users; our goal is to develop new therapies to help cocaine users to have a better health and immunity.

Institution
MUSC
Recruitment Contact
Wei Jiang
8438762457
jianw@musc.edu

Prospective Placebo-Controlled Trial of Intramuscular Steroid Administration for the Treatment of Unexplained Chronic Cough

Date Added
November 5th, 2024
PRO Number
Pro00140403
Researcher
Lauren Howser

List of Studies

Keywords
Throat
Summary

This study is being done to see if injections in different locations can help to minimize chronic cough. This is done through the injection of an anti-inflammatory medication (steroid) into your upper arm muscle. The procedure takes less than 5 minutes. There has not yet been a study completed using arm muscle injections. The safety profile of arm muscle injections is expected to be the same as the superior laryngeal nerve (SLN) injection which is in the neck is already used at MUSC in regular practice. This is the same medication and the same dosage as the arm injection in this study. By better understanding if this treatment helps improve chronic cough, an additional treatment option could be utilized for this patient population. SLN injections are usually only performed by fellowship trained laryngologists (an extra specialized year of training after ENT residency). However, if arm muscle injections are found to be equivalent in treating chronic cough, general ENT physicians could likely provide this treatment to their patients without the need to see a specialized laryngologist. This study will evaluate safety and effectiveness of the arm muscle injection. Steroids are investigational for the purpose of this study.

Institution
MUSC
Recruitment Contact
Kirsten Meenan
843-792-6755
meenan@musc.edu

Integrated Treatment for Opioid Use Disorder and PTSD

Date Added
November 5th, 2024
PRO Number
Pro00138487
Researcher
Tanya Saraiya

List of Studies

Keywords
Mental Health, Psychiatry, Substance Use
Summary

This study will test a therapy intervention, HOPE, for individuals with opioid use disorder and postttraumatic stress disorder. Interested individuals will need to be taking medications for opioid use disorder (e.g., suboxone, naltrexone, methadone). Interested participants will complete a 10-12 week therapy, and be asked to complete surveys.

Institution
MUSC
Recruitment Contact
Tanya Saraiya
347-961-8252
pathlab@musc.edu

Atomoxetine Effect on Attention, Executive Function, and Quality of Life in Veterans with Posttraumatic Stress Disorder

Date Added
November 5th, 2024
PRO Number
Pro00137933
Researcher
Zhewu Wang

List of Studies


Keywords
Psychiatry, Stress Disorders
Summary

The purpose of this research study is to determine the effectiveness of Atomoxetine, a medication approved for attention deficit hyperactivity disorder (ADHD), in improving quality of life as well as attention and mental skills such as memory, daily planning, and impulse control in Veterans with ADHD and post-traumatic stress disorder (PTSD). Reduced attention span, concentration difficulties, impaired inhibition and decision-making abilities, and memory problems are all symptoms of ADHD, and may be a factor in the current issue of PTSD treatment-resistance. Therefore, this study is aimed to examine the effect of atomoxetine on attention and executive function, which may lead to a significant improvement in overall ADHD and PTSD outcomes.

Institution
MUSC
Recruitment Contact
Maria Rafferty
8433371418
raffertr@musc.edu

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated with Shift Work Disorder

Date Added
November 1st, 2024
PRO Number
Pro00138871
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of Solriamfetol (versus placebo) for the treatment of excessive sleepiness associated with shift work disorder (SWD). Study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 18-65 years old with a diagnosis of SWD. The study will last approximately 17 weeks, with 6 in-person visits and 8 remote visits for each participant.

Institution
MUSC
Recruitment Contact
Jelissa Suarez
843-876-9262
suarezj@musc.edu

Phase 3 Randomized Open-label Study of Adjuvant Pembrolizumab W/WO MK2870 in Resectable Stages II-IIIB(N2) NSCLC for Patients not AchievingpCR After Receiving Neoadjuvant Pembrolizumab with Platinum-Based Doublet Chemotherapy Followed by Surgery

Date Added
October 31st, 2024
PRO Number
Pro00138712
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This research study is testing a new treatment plan for patients with a type of lung cancer that can be surgically removed. The study focuses on patients who have not had complete success with initial treatments before surgery. The treatment plan includes a combination of chemotherapy and a drug called pembrolizumab before surgery, followed by surgery to remove the cancer, and then more pembrolizumab with or without another drug called MK-2870 after surgery.

The goal is to see if adding MK-2870 can help improve the chances of recovery and prevent the cancer from coming back in patients who didn't respond fully to the initial treatment. This study aims to find better ways to treat lung cancer and improve the survival rates of these patients.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinicaltrials@musc.edu

A Randomized Phase III Trial of Doxorubicin +Pembrolizumab Versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas

Date Added
October 25th, 2024
PRO Number
Pro00139599
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer, Cancer/Sarcoma, Drug Studies, Men's Health, Women's Health
Summary

This study if for patients with undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started to other places in the body or it cannot be removed by surgery. This study compares the effect of pembrolizumab plus doxorubicin to doxorubicin alone in treating patients. Doxorubicin damages the cell's DNA and may kill tumor cells. Doxorubicin also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attach the cancer and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to the standard chemotherapy, doxorubicin, may help patients with UPS or a related poorly differentiated sarcoma live longer without having disease progression. The duration of the study will be about 12 years, with 6 months of active treatment for those receiving doxorubicin alone and 2 years active treatment for those receiving doxorubicin and pembrolizumab. Each participant will be in follow up for 10 years. Some of the main side effects are nausea, vomiting, low blood count, fatigue and mild diarrhea.

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

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to evaluate Dostarlimab as Sequential Therapy after Chemoradiation in Participants with Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Date Added
October 25th, 2024
PRO Number
Pro00136526
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies
Summary

This phase III study evaluates whether a new drug, dostarlimab, can delay or reduce the risk of cancer returning when administered for a year, shortly after receiving a combination of radiotherapy and chemotherapy (CRT). This study will enroll adults diagnosed with head and neck cancer who are treated with CRT. This study is divided into three parts: the screening period begins shortly after CRT and lasting 4-6 weeks where tests will be conducted to determine eligibility, followed by a 12-month treatment period where participants will receive either dostarlimab or an inactive substance (salt solution) with no effect on your body (placebo), and a follow up period when they will continue to be assessed to see if their cancer has returned or gotten worse. Participants may be on the study for approximately up to 5 years in total. The main risks are anaemia, nausea, vomiting, and diarrhea. Alternatives to this treatment is standard of care CRT because for this type of head and neck cancer, at the present time, there are no other approved therapies administered shortly after CRT that may prevent or delay the return of the cancer. The study benefit is dostarlimab may help slow or stop the growth of your cancer.

Institution
MUSC
Recruitment Contact
HCC clinical trails office
843-792-9321
hcc-clinicaltrials@musc.edu

A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis with rVWF in Children Diagnosed With Severe von Willebrand disease

Date Added
October 22nd, 2024
PRO Number
Pro00137135
Researcher
Shayla Bergmann

List of Studies


Keywords
Adolescents, Blood Disorders, Drug Studies, Pediatrics, Rare Diseases
Summary

The is a Phase 3 study for children, ages 0-17 years old, with severe von Willebrand disease (VWD). In this study, the study drug will be used prophylactically for the treatment of bleeding events. Prophylactic treatment means the study drug will be used to prevent or stop a bleed before it happens.
This study is going to look at how safe the study drug is and how well the study drug (recombinant von Willebrand factor (rVWF, vonicog alfa)), works to prevent and control bleeding.

Institution
MUSC
Recruitment Contact
Linda Wozniak
843-876-8651
wozniakl@musc.edu



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