Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin Save

Date Added
May 18th, 2018
PRO Number
Pro00077581
Researcher
Anand Sharma

Silhouette
Keywords
Cancer, Cancer/Head & Neck, Stage II, Stage III
Summary

This study is for patients that have been diagnosed with stage III-IVB Head and Neck cancer. The investigational drug in this study is MEDI4736 (Durvalumab). The purpose of the safety lead-in portion of the study is to determine whether adding the study drug MEDI4736 to radiation is safe in patients with head and neck cancer who cannot take the drug cisplatin. The purpose of the phase II/III portion is to compare any good and bad effects of usual radiation plus the study treatment, MEDI4736 (durvalumab), to the usual therapy of radiation plus cetuximab in patients with head and neck cancer who cannot take the drug cisplatin. Participants in the safety lead-in portion can expect to be in this study for approximately 2.5 years. Participants in the Phase II/III portion can expect to be in the study for up to 32 weeks, and then followed by their study doctor to monitor for side effects every year.

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

Altering memories that increase risk of relapse in alcohol use disorders: A translational clinical neuroscience pilot investigation of a novel pharmacological agent. Save

Date Added
February 6th, 2018
PRO Number
Pro00073523
Researcher
Michael Saladin

Silhouette
Keywords
Alcohol, Drug Studies, Stage II
Summary

The proposed study will employ treatment-seeking AUD individuals who will be randomly assigned to receive either 15 mg of rapamycin (sirolimus) or placebo immediately after the first of two alcohol cue exposure sessions scheduled to occur on consecutive days. Subjective responses (i.e., craving) and physiological (heart rate & skin conductance) reactivity will be obtained before, during and after cue presentations in both sessions. The durability of any observed treatment effects will be assessed in a Follow-up session performed approximately 10 days following completion of the second session. Treatment effects on self-report measures of drinking behavior during the approximately 10 days preceding the Follow-up session will also be assessed.

Institution
MUSC
Recruitment Contact
Emily Burns
843-792-6984
burnsemi@musc.edu

Improving Resection Rates among African Americans with NSCLC ("Southern Lung Cancer Study") Save

Date Added
May 13th, 2015
PRO Number
Pro00042975
Researcher
Marvella Ford

Silhouette
Keywords
Cancer, Cancer/Lung, Minorities, Stage I, Stage II, Surgery
Summary

The goal of this study is to improve rates of lung-directed therapy with curative intent (LDTCI) among African Americans with probable or proven early stage non-small cell lung cancer via a patient navigation intervention. Study participants will be recruited from study sites across the southern US, including the Medical University of South Carolina Hollings Cancer Center (MUSC HCC) and the Comprehensive Cancer Center of Wake Forest NCORP Research Base (WF NCORP RB) and its affiliated sites. Participants will be randomized by study site. This study does not include blood draws or therapeutic interventions. During the one-year follow-up period, each participant will complete 5 telephone surveys.

Institution
MUSC
Recruitment Contact
Kendrea Knight
843-876-2452
knightkd@musc.edu

Pro00040590: Peers Promoting Exercise Adoption and Maintenance among Cancer Survivors Save

Date Added
March 2nd, 2015
PRO Number
Pro00040590
Researcher
Bernardine Pinto

Silhouette
Keywords
Cancer/Breast, Exercise, Stage I, Stage II, Stage III
Summary

Exercise adoption enhances well-being and recovery from breast cancer. In two previous studies, we have trained community volunteers with the American Cancer Society to provide exercise counseling for breast cancer survivors and the survivors increased their exercise in the short-term (R01 CA132854). This randomized controlled study examines the effects of three maintenance conditions following the 3-month exercise counseling provided by the community volunteers on exercise participation among breast cancer patients at longer follow-ups.
To begin, all study participants (n=150) will receive a 3-month telephone-based exercise program from Reach to Recovery (RTR) volunteers at the American Cancer Society. This will be followed by three maintenance programs during Months 4-9: Reach Plus (participants will receive exercise logs and feedback reports), Reach Plus Phone (monthly counseling calls from coaches, exercise logs and feedback reports) and 3) Reach Plus Messages (monthly email/text messages, exercise logs and feedback reports).
We will enroll 150 women who have completed treatment for breast cancer and assess their exercise behavior, fatigue, quality of life, and mood at baseline (before the 3 month exercise program), 3, 6, 9 and 12 months. The costs and effectiveness of the three groups will be examined to help guide future dissemination of this peer mentoring approach in community-based organizations to enhance cancer survivorship.

Institution
Palmetto
Recruitment Contact
Bernardine Pinto
803-777-9272
pintob@mailbox.sc.edu

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