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

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

List of Studies

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.

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

List of Studies

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
Brittany Frasier
843-792-6984
frasibri@musc.edu



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