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

Pulmonary Artery Denervation Clinical Study using the Gradient Denervation System in Heart Failure Patients with Pulmonary Hypertension Group 2

Date Added
March 26th, 2024
PRO Number
Pro00135798
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular, Heart, Pulmonary Hypertension
Summary

This study is for patients who have heart failure with pulmonary hypertension. Heart failure means that the heart cannot pump blood as well as normal. Pulmonary hypertension happens when the pressure in the blood vessels leading from the heart to the lungs is too high, blood flowing through the lungs is limited, and the pressure in the lungs increases when you are physically active, causing symptoms of shortness of breath and tiredness.

The study uses the Gradient device to see if can help treat heart failure with pulmonary hypertension. This device and therapy is still investigational, which means it is currently not approved by a regulatory agency (such as U.S Food and Drug Administration) for regular hospital use and it includes only individuals who choose to take part. Risks in this study include those for standard cardiac catheterization techniques and the administration of anesthesia including allergic reactions, low blood pressure, skin rash, or difficulty breathing; however, all of the risks may not be known. The study will last approximately 3 years and includes the following visits: Baseline/Screening, Procedure, Discharge, 1 month, 6 months and visits annually for 3 years. Study related procedures include a physical exam, blood testing, 6 minute walk test, echocardiogram, CT scan and a Right heart catheterization.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843 876-5009
awkar@musc.edu

Clinical Safety and Performance of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation

Date Added
April 9th, 2024
PRO Number
Pro00135936
Researcher
Nicholas Amoroso

List of Studies


Keywords
Heart, Surgery
Summary

This study is for participants who have tricuspid regurgitation, a condition in which your heart's tricuspid valve does not close tightly which causes blood to flow backwards in the incorrect direction. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. In this study, a device called the VDyne Transcatheter Tricuspid Replacement System will be used to treat the tricuspid regurgitation. The VDyne Transcatheter Tricsupid Replacement System is an investigational device meaning it has not been approved for commercial use by the US Food and Drug Administration (FDA). In this study all eligible participants will be treated with the device.

Participation in this study will last about 5 years and involve up to 13 visits. Study related procedures include a right heart catheterization (test to measure the pressures in the heart), echocardiograms (ultrasound test of heart), electrocardiogram or ECG (test of the heart's electrical system) blood work, questionnaires, hall walk test, and physical exam.

There are risks associated with this study including potential risks with the device, implant procedure and study related procedures. There is also the risk of loss of confidentiality. The study may or may not benefit you but the information learned may benefit others with this condition in the future.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-876-5037
drain@musc.edu

Perspectives on Treatment with CAB+RPV LA Injectable Therapy from People Living with HIV (PWH) in the US with Prior Adherence Challenges to Oral ART

Date Added
April 12th, 2024
PRO Number
Pro00132072
Researcher
Stephanie Kirk

List of Studies


Keywords
HIV / AIDS
Summary

This is a cross-sectional survey in persons with HIV infection to evaluate experiences of historical oral therapy use and how their perceptions on treatment may have changed with the availability of injectable long-acting therapy. In
addition to surveys, a corresponding retrospective medical chart review will be conducted for each participant.

Institution
MUSC
Recruitment Contact
Alicia Hartley
843-792-4100
hartleal@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

BelieveIT-201: A Randomized, Phase 2, Open-label Study of TransCon IL-2 B/y Monotherapy, TransCon IL-2 B/y in Combination with TransCon TLR7/8 Agonist, TransCon TLR7/8 Agonist in Combination with Pembrolizumab, or Pembrolizumab Monotherapy as Neoadjuvant Therapy in Participants with Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Date Added
April 22nd, 2024
PRO Number
Pro00133895
Researcher
John Kaczmar

List of Studies


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

This open-label research study will evaluate two investigational therapies, TransCon TLR7/8 Agonist and TransCon IL-2 β/γ, which are not approved by the U.S. Food and Drug Administration (FDA). Pembrolizumab, an FDA approved medication, also a study drug on this trial is given as standard of care for this type of cancer. This study begins with two study treatment groups, Groups A:TransCon TLR7/8 Agonist injected directed into the tumor once every 21 days and Group B: TransCon IL-2 β/γ which is given through a IV over 30 minutes once every 21 days. The surgery may occur after Cycle 2 of the medications at a scheduled time that the study doctor feels appropriate. Once 12 participants have completed study treatment, 6 in each group (A and B), an analysis will determine the continuation of the study. If it passes the criteria, the study will continue, and another study treatment group, Group C: Pembrolizumad alone given through an IV over 30 minutes once every 21 days, will open. Participants will be randomly assigned to one of the three groups. At the present time, limited information is available on the adverse side effects potentially related to TransCon IL-2 β/γ and TransCon TLR7/8. Very common side effects observed with TransCon IL-2 β/γ include changes with your immune system being stimulated, blood pressure, and heartbeat. Also flu-like symptoms (nausea, fever, and chills), changes in lung/liver/kidney function, and brain related symptoms including dizziness, weakness, confusion, difficulty speaking, and/or decreased brain function, which may become life-threatening. TransCon TLR7/8 Agonist requires more data collection to determine the extent of side effects in humans. At this time, there are no proven benefits in humans however, the animal studies have shown promising results. The national accrual goal for this study is 92 participants and MUSC projects to accrual approximately 5 participants per year over a span of 2 years.

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

A Phase 1/2, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF9001 as a monotherapy and in combination with nivolumab in Patients With Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors, and Expansion in Selected Indications

Date Added
April 24th, 2024
PRO Number
Pro00133820
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer, Drug Studies
Summary

A clinical research study is an investigation in humans of a potential medical treatment that is designed to discover or verify whether it works and is safe. This study will test an investigational drug called DF9001. "Investigational" means that it has not been approved by any health authority such as the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Information gathered from this study will be sent to the various health authorities.
The study has two parts: a Dose Escalation part and an Efficacy Expansion part. The main purpose of the Efficacy Expansion part of this study is to test whether the study drug (DF9001) works (if it causes cancer to shrink or disappear). The Dose Escalation part of this study's main purpose is to test different doses of the study drug by itself, and also in combination with a drug called nivolumab, an FDA approved drug. Some foreseeable risks associated with DF9001 include Diarrhea,
Skin problems, Nail changes, Eye problems, Inflammation of the lungs, intestines and liver, as well as unforeseen side effects that may occur. There is no direct benefit in participating in this study.

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

Patient Registry for Participation in Aging/Alzheimer's Research (PREPARE)

Date Added
May 3rd, 2024
PRO Number
Pro00135842
Researcher
Stephanie Aghamoosa

List of Studies

Keywords
Aging, Alzheimers
Summary

The Patient Registry for Participation in Aging/Alzheimer's Research (PREPARE) is a database of individuals with Mild Cognitive Impairment who are interested in participating in research on aging/Alzheimer's disease and related dementias conducted at the Medical University of South Carolina (MUSC). PREPARE will connect MUSC researchers with potential participants so they can provide information about studies for which they may be eligible. PREPARE will also collect survey data from people with Mild Cognitive Impairment and their study partners to better understand the impact of this condition on daily functioning.

Institution
MUSC
Recruitment Contact
Kaitlin Cox
(843) 608-1674‬
coxkai@musc.edu

A Phase 1 Open Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications

Date Added
May 7th, 2024
PRO Number
Pro00136641
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to evaluate ABBV-400 in subjects with select solid tumors. This study will consist of
multiple cohorts with each cohort investigating ABBV-400 at 3 mg/kg Q3W.
The study will consist of a Screening, a Treatment, and a Follow-Up period.
All screening procedures must be performed within 28 days of first dose with the exception of tumor
tissue biopsy, which may occur during screening or any time after disease progression on the most
recent treatment. Subjects will continue treatment with ABBV-400 3 mg/kg Q3W until documented disease progression,
intolerable toxicity, or the subject meets other protocol criteria for discontinuation of treatment
(whichever occurs first). The maximum treatment duration will be 2 years.

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



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