Pembrolizumab In Combination With Anti-platelet Therapy For Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck

Date Added
August 15th, 2017
PRO Number
Pro00069442
Researcher
John Kaczmar

List of Studies


Keywords
Cancer/Head & Neck
Summary

This is a study that looks at the use of anti-platelet therapy and chemotherapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC). Anti-platelet therapy is the use of drugs that reduce the blood's ability to form clots. The overall goal of this study is to see if this therapy combination can increase the body's ability to fight the disease.

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

Characterization of physiological changes induced through motor-evoked potential conditioning in people with spinal cord injury

Date Added
December 3rd, 2019
PRO Number
Pro00091457
Researcher
Aiko Thompson

List of Studies


Keywords
Central Nervous System, Nervous System, Rehabilitation Studies, Spinal Cord
Summary

We are currently recruiting volunteers who are interested in participating in a brain-spinal cord-muscle response training study that aims to better understand the changes that take place in the nervous system as a result of this type of training. After spinal cord injury, brain-to-muscle connections are often interrupted. Because these connections are important in movement control, when they are not working well, movements may be disturbed. Researchers have found that people can learn to strengthen these connections through training. Strengthening these connections may be able to improve movement control and recovery after injuries.

Research participants will be asked to stand, sit, and walk during the study sessions. Electrodes are placed on the skin over leg muscles for monitoring muscle activity. For examining brain-to-muscle connections, we use transcranial magnetic stimulation. The stimulation is applied over the head and will indirectly stimulate brain cells with little or no discomfort.

Participation in this study requires approximately three sessions per week for four months, followed by two to three sessions over another three months. Each session lasts approximately 1 hour. Participants will receive a mileage reimbursement.

Institution
MUSC
Recruitment Contact
Blair Dellenbach
843-792-6313
stecb@musc.edu

Implementation and Effectiveness Trial of HN-STAR

Date Added
October 12th, 2020
PRO Number
Pro00104287
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer, Cancer/Head & Neck
Summary

This study is for patients that have been diagnosed with head and neck cancer. The purpose of this study is to examine whether HN-STAR can help healthcare providers care for survivors of head and neck cancer.

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

A Phase 2, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)

Date Added
February 1st, 2021
PRO Number
Pro00101229
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with head and neck squamous cell carcinoma (HNSCC) that has returned (recurrent) or spread after previous treatment (metastatic). The investigational drug in this study is lenvatinib. The study will also use lenvatinib in combination with pembrolizumab, which is also experimental. The purposes of this study are to: test the safety of the study drugs, lenvatinib alone, pembro and lenvatinib together, and standard chemotherapies alone in the treatment of HNSCC; see how well the combination of pembro and lenvatinib works, compared to standard chemotherapies; and see if participants who get pembro and lenvatinib live longer than those who are treated with standard chemotherapies. Participants can expect to be on this study for about 48 months.

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

Modeling and Modulating Mechanisms of Escape, Avoidance, and Approach in the Anxiety Disorder Spectrum

Date Added
February 2nd, 2021
PRO Number
Pro00106843
Researcher
Christopher Sege

List of Studies


Keywords
Anxiety, Brain
Summary

This is a study to find out if a device that temporarily alters brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how people with anxiety or related concerns cope with emotional situations. The study is recruiting people who recently started treatment for anxiety or a related concern. The study involves 3 visits to MUSC. At the first visit, participants do interviews and surveys asking about anxiety and related concerns, and they also do tasks where they see and react to emotional pictures while their brain activation is measured. At the next two visits, participants receive rTMS that uses a magnet placed on top of the head to alter brain activity temporarily (for about an hour). After rTMS, participants do two tasks where they see and react to emotional situations while wearing sensors on their hand, arms, face, and head.

Each visit in this study is expected to last between 2 – 3 hours. This study is not a treatment study, but it could help improve treatment in the future. Participants in this study are paid for their time.

Institution
MUSC
Recruitment Contact
Christopher Sege
8437928465
sege@musc.edu

A Phase II Randomized Trial of Adjuvant Therapy With Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma With High Risk Features

Date Added
May 14th, 2021
PRO Number
Pro00110906
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer, Cancer/Head & Neck
Summary

This study is for patients that have been diagnosed with recurrent or new head and neck squamous cell carcinoma (HNSCC). Patients either have had a recurrence (the tumor has comeback) or a new head and neck cancer in a different area of the head and neck (second primary) which has been removed by surgery. The study drug used is called pembrolizumab. The purpose of this study is to see if adding pembrolizumab to radiation or if using pembrolizumab by itself after surgery compared to the usual approaches with chemotherapy and radiation will increase life expectancy. Participants can expect to be on this study for up to 12 months and then followed for 5 years.

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

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGF-β Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients with EGFR-Driven Advanced Solid Tumors

Date Added
July 27th, 2021
PRO Number
Pro00111442
Researcher
John Kaczmar

List of Studies


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

This study is for patients who have advanced cancers, such as head and neck cancer, colorectal cancer, breast cancer, and others. This study is testing a new treatment for these types of cancer. The new test drug is called BCA101. Pembrolizumab is an approved drug by the United States Food and Drug Administration (FDA) for the diseases described in this study and will be used as approved. The type of cancer a patient has will determine whether he/she will get BCA101 alone or BCA101 in combination with pembrolizumab. Participants will receive either BCA101 alone, BCA101 in combination with pembrolizumab or BCA101 and enforafenib, depending on your cancer until the cancer gets worse, they experience bad side effects, or until they withdraw consent, or until the Investigator considers it is in his/her best interest to discontinue the study drug.

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

Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth

Date Added
October 19th, 2021
PRO Number
Pro00113242
Researcher
Jonathan Halford

List of Studies

Keywords
Epilepsy
Summary

This study aims to improve access of Veterans with epilepsy living in rural areas to the most important diagnostic procedure for the care of patients with epilepsy: the routine electroencephalogram (EEG). We will test a new method for recording EEG which uses a novel dry electrode system headset that does not require an EEG technologist to operate. The headset integrates the EEG electrodes and amplifier into a compact system which is easily placed on the head. This approach could make it possible for a nurse or nurse assistant with minimal training to record an EEG in a rural community based outpatient clinic (CBOC) as part of an epilepsy telemedicine outreach program along with clinical interviews. We will compare performance of this dry electrode system to standard EEG when it is used by EEG technologists in three VA medical centers. This project has the potential to improve access of Veterans to the EEG procedure and decrease cost to the Veterans Health Care System.

Institution
MUSC
Recruitment Contact
to be decided
843-789-7428
jonathan.halford@va.gov

Randomized Phase II/III Trial of Radiation with High-Dose Cisplatin (100mg/m2) Every Three Weeks Versus Radiation with Low-Dose Cisplatin (40mg/m2) for Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Date Added
June 6th, 2022
PRO Number
Pro00120883
Researcher
Bhishamjit Chera

List of Studies

Keywords
Cancer, Cancer/Head & Neck
Summary

This study is for patients who have been diagnosed with locoregionally advanced squamous cell carcinoma. The purpose of this study is to compare two usual treatment approaches to head and neck cancer: high-dose cisplatin given every 3 weeks with radiation to low-dose cisplatin given weekly with radiation. The usual approach for patients who are not in this study is treatment with radiation therapy combined with the chemotherapy drug cisplatin. Cisplatin is a drug approved by the Food and Drug Administration (FDA) to treat your head and neck cancer. Cisplatin can be given at different doses and at different times during radiation, but the most common way to give cisplatin is either as a high-dose every 3 weeks or a low-dose weekly during radiation. Participants can expect to be on this study for up to 7 weeks and then followed annually until disease progression.

Institution
MUSC
Recruitment Contact
Lydia Moats
864-725-7125
lydia.moats@selfregional.org

A Multi-Site Randomized Clinical Trial Comparing a Brief Tele-Cognitive Behavioral Therapy Intervention (BRIGHT) with Attention Control for the Management of Body Image-Related Distress Among Head and Neck Cancer Survivors

Date Added
August 2nd, 2022
PRO Number
Pro00110248
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer/Head & Neck
Summary

Because head and neck cancer arises in cosmetically and functionally critical areas, head and neck cancer survivors suffer high rates of body image-related distress. Body image-related distress is a source of significant morbidity, contributing to stigmatization, social isolation, and worse quality of life. Unfortunately, effective therapies exist to manage body image-related distress among head and neck cancer survivors are lacking. We have developed a novel, scalable, tele-cognitive behavioral therapy intervention for head and neck cancer survivors with body image disturbance that could provide the first effective treatment in this population, thereby minimizing psychosocial morbidity, improving quality of life, and developing new standards of clinical care.

Institution
MUSC
Recruitment Contact
Evan Graboyes
843-791-0719
graboyes@musc.edu



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