STEER (Screening, Training, Education, Evaluation, Resources) Away from Alcohol and Drugs. + save

Date Added
November 8th, 2012
PRO Number
Pro00016995
Researcher
Deborah Deas
Keywords
Alcohol, Drug Studies, Education
Summary

Our project, “STEER” Away from Alcohol and Drugs will have a multi-faceted approach: Screening, Training, Educating, Evaluating, and providing Resources for treatment. The specific aims are: to screen individuals at local health fairs, community centers, and other community facilities for alcohol and drugs using evidence-based questionnaires; to train interdisciplinary professionals (nurses, social workers, psychologists, physicians, physician assistants, etc. to assess, evaluate and treat alcohol and drug use in patients in various clinical settings; and to evaluate the impact of the STEER program on community leaders' attitudes and knowledge.

Institution
MUSC
Recruitment Contact
E'lisha Simmons
843-792-5423
simmonac@musc.edu

A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon α-2b for Resected High-Risk Melanoma + save

Date Added
November 1st, 2012
PRO Number
Pro00020648
Researcher
Charles Bowers
Keywords
Cancer, Cancer/Skin, Drug Studies
Summary

The primary objective of this study is to evaluate overall survival between patients randomized to receive post-operative ipilimumab versus those randomized to receive high-dose interferon.
Secondary objectives are to:

- Compare disease recurrence-free survival in the two groups;
- Evaluate safety and tolerability of post-operative ipilimumab therapy; and
- Compare the quality of life between the two groups.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

A Phase III Randomized, Double-Blind Trial of Chemoembolization with or without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients with and without Vascular Invasion + save

Date Added
October 24th, 2012
PRO Number
Pro00020435
Researcher
Charles Bowers
Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies, Liver
Summary

The purpose of this study is to see if adding the oral chemotherapy pill, sorafenib (Nexavar), to localized chemotherapy (chemoembolization) to the liver will help patients to live longer than treatment with localized chemotherapy to the liver without sorafenib. Sorafenib is currently approved by the United States Food and Drug Administration for the treatment of liver cancer. It is not known if the combination of chemoembolization and sorafenib will work better than chemoembolization alone.

The part of this study considered “investigational” is the addition of sorafenib to chemoembolization for the treatment of unresectable hepatocellular carcinoma (HCC).

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

A Phase 2, randomized, double-dummy, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-923 (dextromethorphan/quinidine) for the treatment of symptoms of agitation in patients with Alzheimer’s disease. + save

Date Added
October 23rd, 2012
PRO Number
Pro00020245
Researcher
Jacobo Mintzer
Keywords
Aging, Alzheimers, Brain, Dementia, Drug Studies, Memory Loss
Summary

The objectives of the study are to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of AVP-923 compared to placebo, for the treatment of symptoms of agitation in patients with AD.

Institution
MUSC
Recruitment Contact
Marie Corbin
843-740-1592
corbinm@musc.edu

Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer + save

Date Added
October 6th, 2012
PRO Number
Pro00012190
Researcher
Patricia Griffin
Keywords
Cancer, Drug Studies
Summary

Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer.

This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

Phase II placebo-controlled trial of lisinopril and Coreg CR® to reduce cardiotoxicity in patients with breast cancer receiving (neo)adjuvant chemotherapy with trastuzumab (Herceptin®) + save

Date Added
October 2nd, 2012
PRO Number
Pro00005411
Researcher
Amarinthia Curtis
Keywords
Cancer, Cancer/Breast, Drug Studies, Heart, Hypertension/ High Blood Pressure
Summary

The purpose of this study is to compare the effects, good and/or bad, of an ACE inhibitor (lisinopril) or a beta-blocker (Coreg CR® [carvedilol phosphate extended release]) on heart function during treatment with trastuzumab (Herceptin®), a drug subjects will receive as treatment for breast cancer. Lisinopril and Coreg CR® are used to treat high blood pressure, heart failure and in heart attack patients. Study doctors want to find out which treatment (lisinopril or Coreg CR®) is better at protecting heart function during treatment of breast cancer. The effect of the medicines will be compared to a placebo, which contains no active drug. Subjects will only get one of the study medicines (lisinopril, Coreg CR® or placebo).

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer + save

Date Added
September 20th, 2012
PRO Number
Pro00021060
Researcher
Patricia Griffin
Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Head & Neck, Drug Studies, Throat
Summary

Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer.

This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

An Open-label, Multi-center Phase I Dose-finding Study of RAD001 (everolimus, Afinitor®) in Combination with BEZ235 in Patients With Advanced Solid Tumors + save

Date Added
September 11th, 2012
PRO Number
Pro00018619
Researcher
Carolyn Britten
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

The primary purpose of this trial is to find the right dose of RAD001 and BEZ235 when they are taken in combination. Once the right dose is found, then more patients will be asked to join the study to learn if the study drugs RAD001 and BEZ235 can slow or prevent the recurrence of your cancer. The harmful effects of RAD001 and BEZ235 will be studied. Patients' functional status, symptoms, the changes in the size of the tumor and laboratory and other procedures’ findings obtained while patients are receiving the study drug will help the research team to determine if RAD001 and BEZ235 combination is safe and effective in patients with this condition.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

Expanded Access Program of Ponatinib (AP24534) for Patients with Refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia + save

Date Added
September 11th, 2012
PRO Number
Pro00019630
Researcher
Luciano Costa
Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Minorities, Women's Health
Summary

The purpose of the research study is for patients who have Chronic Myeloid Leukemia (CML) or Philadelphia Positive Acute Lymphoblastic Leukemia (Ph+ ALL) to receive an experimental treatment and other standard treatments haven’t worked or are no longer working for your Leukemia. The purpose of the expanded access program is to provide patients the opportunity to receive the experimental drug ponatinib (also known as AP24534) for treatment of this condition. Ponatinib is being studied as a possible cancer treatment for CML and Ph+ ALL. Experimental means that ponatinib has not yet been approved by any governmental health authority including the US Food and Drug Administration (FDA).

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzersl@musc.edu

Phase II Double-Blinded Placebo-Controlled Study of Bevacizumab With or Without AMG 386 in Patients With Recurrent Glioblastoma or Gliosarcoma + save

Date Added
September 11th, 2012
PRO Number
Pro00019337
Researcher
Patricia Griffin
Keywords
Brain, Brain Tumor, Cancer, Cancer/Brain, Drug Studies, Glioblastoma
Summary

This randomized phase II trial studies how well bevacizumab given with or without AMG 386 (trebananib) works in treating patients with brain tumor.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com