Developing a method of reducing the strength of transcranial focused ultrasound (tFUS) to personalize treatment.

Date Added
March 5th, 2024
PRO Number
Pro00132894
Researcher
Mark George

List of Studies


Keywords
Vision/ Eye
Summary

Transcranial focused ultrasound (tFUS) is a new noninvasive way to stimulate the brain in an awake and alert person. We do not yet have an easily observable way to know whether we are in the right brain location with the correct dose for that person. We wonder if we can produce a transient change in someone's visual field, called a scotoma, and whether we can use that to determine the minimum tFUS dose for that person.

Institution
MUSC
Recruitment Contact
Bridgette Holland
843 876 5142
hollanbr@musc.edu

Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck

Date Added
March 25th, 2024
PRO Number
Pro00134487
Researcher
Bhishamjit Chera

List of Studies

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

This study will evaluate possible new treatments for advanced stage head and neck cancer. Patients who have undergone surgery to remove their tumor may qualify if the tissue is positive for a specific type of squamous cell cancer. The purpose of this study is to compare the current standard treatment, radiation therapy along with chemotherapy with a drug called cisplatin, to two other treatments. One experimental treatment is radiation therapy along with two chemotherapy agents, docetaxel and cetuximab, and the other experimental treatment is the standard treatment currently used along with the addition of an immunotherapy drug atezolizumab. Patients who qualify for participation will be randomly assigned to one of the 3 treatment groups (done with a computerized system). In the current standard treatment group, participants will receive radiation therapy 5 days per week for 6 weeks, and cisplatin once a week through a vein for the 6-week treatment period. The group receiving doxetaxel and cetuximab (both FDA approved medications for the treatment of certain cancers) will receive the same 6 weeks of radiation along with cetuximab through a vein 1 week prior to the start of radiation therapy, and then once a week for the 6 weeks of radiation and the doxetaxel will also be given through a vein once a week for the 6 weeks of radiation therapy. The final group will get the current standard treatment with 6 weeks of radiation and 6 weeks of cisplatin, along with atezolizumab through a vein 1 week prior to your starting radiation and then every 3 weeks for a total of 8 doses, There will be twice as many patients in this last group than the other two groups.

Follow-up will be at Month 1 & 3 and then every 3 months for 2 years, and then every 6 months for 3 more years, and then annually for as long as a participant is willing and able. There will be blood tests and CT scans that will occur throughout the study, however they are standard for the type of cancer being treated and how each individual responds to the treatment. The benefit of participation is there may be improved outcomes in this group of patients however the risks involved with receiving new treatments may be more than with the usual standard treatment. Some of the most common side effects that the study doctors know about are infection, nausea, vomiting, diarrhea, pain, tiredness, kidney problems, numbness/tingling in hands and feet. There may be some risks that the study doctors are not aware of at the moment. There will be a total of up to 480 participants across all sites and approximately 24 participants at MUSC.

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

An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer

Date Added
March 26th, 2024
PRO Number
Pro00135016
Researcher
Mariam Alexander

List of Studies

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

ZL-1310 is a new experimental treatment designed to tackle small cell lung cancer (SCLC), a particularly aggressive form of lung cancer. The drug is an antibody-drug conjugate (ADC) that specifically targets a protein called delta-like protein 3 (DLL3), found in high amounts in SCLC and other neuroendocrine tumors. The study aims to evaluate the safety, effectiveness, and other characteristics of ZL-1310 in patients with SCLC that has relapsed or is resistant to platinum-based treatments. Previous attempts to target DLL3 faced challenges, and ZL-1310 seeks to overcome these issues, providing a potential breakthrough in treating SCLC, where current options are limited, and relapse rates are high. The study hopes to shed light on ZL-1310's potential as a novel and more effective therapy for patients facing few alternatives and poor prognoses.

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

A Phase 2a Study with Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination with Pembrolizumab in Patients with Advanced Solid Tumors

Date Added
April 22nd, 2024
PRO Number
Pro00135670
Researcher
Theodore Gourdin

List of Studies


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

This study is for patients who have been diagnosed with a solid tumor cancer that has continued to grow despite treatments patients have already received (non-small cell lung cancer or urothelial cancer). The study drug is FF-10832 (gemcitabine liposome injection). Gemcitabine is a cancer treatment registered in the US for the treatment of ovarian, breast, non-small cell lung, and pancreatic carcinomas. The study drug is a new, liposomal formulation of Gemcitabine. This new formula was developed to increase the amount of gemcitabine that goes to tumor cells. The study drug will be given to patients by itself, or in combination with pembrolizumab. Pembrolizumab is an approved treatment for many types of cancer. There are two groups that a participant may be assigned to, which group a participant is assigned on will be determined randomly, in a 1:1 ratio, like flipping a coin. The drugs will be given via an infusion. There is a 50% chance of being assigned to either group. Participation in the study will likely last 12 months, but participants may stay on the study longer if the study treatment continues to benefit them. The study consists of a screening visit, treatment visits, end of study visit, and a long-term follow-up.

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

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer

Date Added
April 22nd, 2024
PRO Number
Pro00134671
Researcher
Christopher Rangel

List of Studies

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

This study investigates a new treatment, V940, combined with pembrolizumab for people who've had surgery for non-small cell lung cancer (NSCLC). The goal is to check if this combination is safe, prevents cancer from returning, improves survival, and enhances quality of life compared to a placebo plus pembrolizumab. Participants will receive pembrolizumab, a drug that boosts the immune system to fight cancer. V940, a personalized treatment, uses genetic information from a patient's tumor to create a custom mRNA injection. It's experimental and not FDA-approved, but it offers a novel approach to empower the immune system against cancer, potentially bringing advancements in post-surgery NSCLC care.

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

Phase I trial of Methotrexate, Rituximab, Lenalidomide, and Nivolumab (Nivo-MR2) Induction Followed by Lenalidomide and Nivolumab Maintenance in Primary CNS Lymphoma

Date Added
May 7th, 2024
PRO Number
Pro00134612
Researcher
Scott Lindhorst

List of Studies


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

This phase I trial will determine the maximum tolerated dose of lenalidomide when given in combination with high-dose systemic methotrexate and rituximab, with or without nivolumab, as induction treatment of primary central nervous system lymphoma. In addition, whether the combination of drugs can extend the control of CNS lymphoma by being used as maintenance (prolonged treatment) after control is achieved with the initial chemotherapy regimen (induction) will be judged. If decided to take part in the study, participants will complete pre-study testing, and if allowed to participate in study different people will get different doses of the study drug lenalidomide during induction chemotherapy. If the drug does not cause serious side effects, the next group of people in the study will get a higher dose, and the doses will continue to increase for every new group until people have serious side effects that require the dose to be lower. Lenalidomide will be taken by mouth on days 5 to 14 of each induction cycle. Once the dose of lenalidomide is found, the next group of people in the study will receive nivolumab in combination with the other drugs (methotrexate, rituximab, and lenalidomide). The first drug administered in each cycle is rituximab, which is given as an intravenous infusion typically in the infusion center. The day after rituximab, participants will be admitted to the hospital for the infusion of methotrexate. Enrolled participants that present benefit after induction will receive lenalidomide and nivolumab as prolonged therapy (maintenance) for an additional 12 months (12 cycles and each cycle is 28 days) or until the disease gets worse or the side effects become too severe. After treatment is completed the study doctor will continue to follow up on participants condition for 2 years to observe side effects. After 2 years the doctor will continue to follow up either in clinic or by phone for up to 5 years after registration. The most common side effects known are kidney damage, infusion reaction, blood clots, birth defects, immune toxicity, fever and infections, and there may be some risks that the study doctor is not aware of yet. Once the combination is proven safe, this study will allow for future studies to determine whether the combination of these four drugs can improve the response to treatment and help increase the understanding of their use in primary CNS lymphoma treatment. It is unclear whether these drugs will help participants live longer than the usual approach alone.

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

RANDOMIZED CONTROLLED TRIAL OF WEEKLY ORAL ISOTRETINOIN VS. ORAL TETRACYCLINES FOR THE TREATMENT OF MODERATE ACNE VULGARIS

Date Added
May 7th, 2024
PRO Number
Pro00131877
Researcher
Alexandra Richmond

List of Studies

Keywords
Drug Studies, Skin
Summary

In the effort to find better treatments for moderate acne, which often relies on long-term antibiotic use, researchers are exploring alternative options. While isotretinoin, a vitamin A derivative, is highly effective for severe acne, its side effects limit its use for milder cases. A recent study from our institution investigated a new approach: weekly isotretinoin dosing. The results were promising, with acne improvement and no major side effects. This suggests that weekly isotretinoin could be a successful alternative for moderate acne in both males and females. To validate these findings, we propose a randomized controlled trial comparing weekly isotretinoin to daily doxycycline over four months. This study could confirm the safety and effectiveness of weekly isotretinoin, as well as shed light on patient satisfaction, and long-term results compared to standard antibiotics. This research may offer a breakthrough in treating moderate acne while addressing concerns about antibiotic overuse.

Institution
MUSC
Recruitment Contact
Alexandra Richmond
‭(757) 777-6673‬
ritteral@musc.edu

Development of a mHealth Post-Stroke Home Exercise Program with Remote Monitoring and Intervention

Date Added
May 21st, 2024
PRO Number
Pro00137156
Researcher
Na Jin Seo

List of Studies


Keywords
Exercise, Movement Disorders, Nervous System, Physical Therapy, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Adherence to home exercise is important to achieve upper limb recovery after stroke. However, adherence is typically low. Therefore, a new home exercise program with an Apple Watch and iPhone app was created to improve adherence to upper limb exercises for stroke survivors at home. Participants will come to our lab to experience the new home exercise program. Participants who opt for home use will bring the device home to try the new home exercise program at home. The purpose of this study is for researchers to examine usability and feasibility of participants using the new home exercise program.

Institution
MUSC
Recruitment Contact
Ja'Quann Gallant
843-792-0162
gallantj@musc.edu

A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy

Date Added
May 28th, 2024
PRO Number
Pro00135072
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

This research study is being done to see the effectiveness and safety of a new drug called BHV-7000 as a possible treatment for focal seizures for patients who are taking anti-seizure medications (ASMs) and still experience seizures. Participation in this study is expected to last approximately 18 to 20 weeks, or about 4 months.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
18437921115
bulgarino@musc.edu

Pivotal Clinical Trial Evaluating Safety and Efficacy of Cardiac Radioablation versus Catheter Ablation for Patients with High-risk refractory Ventricular Tachycardia

Date Added
May 28th, 2024
PRO Number
Pro00135334
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Cardiovascular, Heart
Summary

This study is enrolling subjects with an abnormal heart rhythm called ventricular tachycardia (VT - rapid heart beat coming from the bottom of the heart) that has come back despite treatment. This is a randomized study meaning subjects will be assigned to one of two groups and then undergo either a standard catheter ablation or a new treatment called cardiac radioablation for their VT. You will have a 50:50 chance of being assigned to either group. A standard catheter ablation is done by placing catheters (long hollow tubes) into a large blood vessel at the top of the leg, guiding them to the heart to first identify the signals causing the VT and then use radiofrequency (heat) energy to burn and stop these signals to stop the VT. The cardiac radioablation is an investigational treatment meaning it is not yet approved for routine clinical use by the Food and Drug Administration (FDA). Cardiac radioablation is performed in the radiation oncology department and uses radiation therapy to treat the signals causing the VT. Participation in this study will last up to 5 years and inlcude about 15 visits. Study related procedures include medical record review and data collection, electrocardiogram (tracing of heart's electrical activity), echocardiogram (ultrasound test of the heart), CT scans, blood work, questionnaires, implantable cardioverter defibrillation (ICD - device implanted in your chest that monitors and treats abnormal heart rhythms), and ablation procedure per randomization. Risks include fatigue, changes in the appearance of the lungs in the cardiac radioablation group, fatigue, pain, low or high blood pressure or excessive bruising or bleeding at the catheter insertion side in the cardiac ablation arm. There are also study procedure related risks, and risks that are not known. There is potential benefit to you and to others in learning how to better treat others in the future with this condition.

Institution
MUSC
Recruitment Contact
Chandler Schwede
843-792-5998
schwede@musc.edu



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