A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy Save

Date Added
December 9th, 2019
PRO Number
Pro00091697
Researcher
Paul O'brien

List of Studies

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

This study is for patients that have been diagnosed with differentiated thyroid cancer (DTC). The investigational drug used in this study is cabozantinib. The purpose of this study is to evaluate the effect of cabozantinib compared with a placebo in treating patients whose disease has progressed after receiving prior treatment with drugs that inhibit growth of tumor blood vessel (VEGFR-targeted therapy) for their thyroid cancer. Participants can expect to be on this study for about a year including 9 months of treatment, a follow-up visit 4 weeks after treatment and 3 months of follow up.

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

A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer Save

Date Added
November 13th, 2019
PRO Number
Pro00093609
Researcher
Anand Sharma

List of Studies


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Keywords
Cancer/Head & Neck
Summary

This study is for patients with low-risk, Human Papillomavirus (HPV) positive oropharyngeal cancer. The first part of the study is to determine if a reduced dose of radiation along with chchemotherapy or immunotherapy result in the same length of time without the cancer getting worse as the usual approach. The second part of this study is being done to also see if quality of life with a reduced dose of radiation with chemotherapy or immunotherapy than the usual approach.

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

A Single-Site, Parallel-Group, Randomized-Controlled Pilot Trial Comparing BRIGHT with Active Control in Reducing Body Image Disturbance Among Head and Neck Cancer Survivors (BRIGHT 2.0) Save

Date Added
November 5th, 2019
PRO Number
Pro00085204
Researcher
Evan Graboyes

List of Studies

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Keywords
Cancer/Head & Neck
Summary

Head and neck cancer arises in cosmetically and functionally critical areas of the face. As a result of head and neck cancer and its treatment, head and neck cancer survivors face significant issues related to disfigurement, difficulty swallowing, and challenges speaking. Unfortunately, we do not have effective ways to treat body image concerns in head and neck cancer survivors. Therefore we developed BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment), a new telemedicine intervention for head and neck cancer survivors with body image concerns. The purpose of this study is to evaluate the effectiveness of BRIGHT as a new treatment strategy for head and neck cancer survivors with body image concerns.

Institution
MUSC
Recruitment Contact
Courtney Marsh
843-792-0719
marshch@musc.edu

A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults with Head and Neck Cancer Save

Date Added
September 24th, 2019
PRO Number
Pro00091445
Researcher
John Kaczmar

List of Studies

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

This study is for patients that have been diagnosed with head and neck squamous cell cancer (HNSCC). The investigational drug in this study is ADU-S100. The purpose of this study is to find out how ADU-S100 and pembrolizumab (also called KEYTRUDA®) interact with the immune system to potentially treat cancer and to make sure the drugs are safe to use together. Participants can expect to recieve treatment for up to two years. This would include 2 doses in a3-week cycle for up to 35 cycles. Participants can expect follow-up to continue every eight weeks until completion of the required safety reporting periods, death, withdrawal of consent, loss to follow-up, or close of study by the Sponsor.

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

A Phase II/III Randomized Study of Maintenance Nivolumab Versus Observation in Patients With Locally Advanced, Intermediate Risk HPV Positive OPCA Save

Date Added
September 17th, 2019
PRO Number
Pro00092534
Researcher
John Kaczmar

List of Studies

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Keywords
Cancer/Head & Neck
Summary

This study is for patients with HPV positive oropharynx cancer. The purpose is to determine if maintenance nivolumab following definitive therapy with radiation and chemotherapy (cisplatin) result in significat improvement in overall survival (OS) (time being alive) and progression-free survival (PFS) (time being alive without cancer).

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

A Single-Site, Parallel-Group, Randomized-Controlled Trial of Navigation Versus Usual Care for The Management of Delays and Racial Disparities Starting Postoperative Radiation Therapy in Adults with Surgically-Managed, Locally Advanced Head and Neck Squamous Cell Carcinoma (NDURE 2.0) Save

Date Added
July 27th, 2019
PRO Number
Pro00091049
Researcher
Evan Graboyes

List of Studies

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Keywords
Cancer/Head & Neck
Summary

The purpose of this study is to evaluate whether a new patient navigation intervention can decrease delays starting radiation therapy after surgery for white and African-American head and neck cancer patients. Patients who have surgery and radiation for certain types of head and neck cancer are eligible for this study.

Institution
MUSC
Recruitment Contact
Courtney Marsh
(843) 792-0719
marshch@musc.edu

A Phase 1b Study of ASP1948, Targeting an Immune Modulatory Receptor, as a Single Agent and in Combination with Nivolumab in Subjects with Advanced Solid Tumors Save

Date Added
July 23rd, 2019
PRO Number
Pro00087949
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Breast, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung
Summary

The purpose of this study is to determine at what dose the study drug (ASP1948) is safe and tolerated and how it is processed in the blood of patients with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body. When the safe dose is identified, it will be used to evaluate if the study treatment causes tumors to shrink in patients.The screening period for this study can take up to 28 days. The treatment period consists of up to 48 weeks of initial treatment, followed by up to 45 weeks of follow up. If you quality and are willing to continue in the re-treatment period (receiving the study drug again), you will be in the study for an additional 48 weeks.

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

A Phase II Study of Durvalumab (MEDI 4736) with Radiotherapy for the adjuvant treatment of Intermediate Risk Head and Neck Squamous Cell Carcinoma Save

Date Added
July 23rd, 2019
PRO Number
Pro00089876
Researcher
John Kaczmar

List of Studies

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

This study is for patients who have been diagnosed with locally advanced squamous cell carcinoma of the head and neck (SCCHN) and will need additional treatment following surgery. The investigational drug in this study is Durvalumab. The purpose of this study is to investigate other drugs that may be combined with radiation to treat SCCHN. The study focuses on determining whether durvalumab combined with radiation will have improved 3-year disease free survival compared to historical control. Participants can expect to be in this study for 5 years.

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

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma Save

Date Added
July 18th, 2019
PRO Number
Pro00087838
Researcher
John Kaczmar

List of Studies

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

This study is for patients that have been diagnosed with with resectable High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC). The investigational drug used in this study is Pembrolizumab. The purposes of this study are to: determine how well pembrolizumab keeps the cancer from coming back or spreading as compared to placebo, determine if giving pembrolizumab after surgery and radiation helps patients live longer, and to test the safety of the study drug and see how patients' bodies handle it. Participants can expect to be in this study for about 8 years. This includes the time that participants will be on study drug and in follow up to see if the cancer has come back or spread.

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

Hyperbaric Oxygen Radiation Sensitization for Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck Save

Date Added
May 22nd, 2019
PRO Number
Pro00079382
Researcher
Richard Clarke

List of Studies

Keywords
Cancer/Head & Neck, Stage III, Stage IV
Summary

This study is designed to answer the question "Does the addition of hyperbaric oxygen to radiation and chemotherapy improve outcomes in locally advanced head and neck squamous cell carcinomas?"
There is reason to believe that provision of hyperbaric oxygenation immediately (within 15 minutes) prior to radiation therapy will improve radiation's effect on tumor cells, particularly those that reside in a low oxygen environment.This concept has been proven in implanted tumor-bearing animals. Several small case series suggest there is a modest extension of survival in malignant gliomas.
Squamous cell carcinomas are particularly suited to hyperbaric sensitization as they have a relatively large number of hypoxic cells.
Patients concurrently receiving chemo-radiation standard of care will be placed into a hyperbaric chamber and randomized to receive either pressurized oxygen (the experimental group) or pressurized air (the sham control group).This process will be repeated prior to each scheduled radiation treatment.
Primary outcomes to be assessed are progression-free survival and disease-free survival at two years.
Several other institutions with join in this research initiative, both in the US and internationally.

Institution
Palmetto
Recruitment Contact
Richard Clarke
803.600.3510
dick.clarke@palmettohealth.org

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