A Phase II Randomized, Double-Blind Study of Dalantercept plus Axitinib Compared to Placebo plus Axitinib in Patients with Advanced Renal Cell Carcinoma Save

Date Added
May 13th, 2014
PRO Number
Pro00033034
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Women's Health
Summary

This study is for individuals with renal cell carcinoma (RCC). The purpose of this study is:

?To find out whether the study treatment can stop your RCC from growing, or prevent it from growing as fast as it would without dalantercept.
?To evaluate the safety of the study treatment in subjects with RCC.
?To find out if the study treatment has an effect on biomarkers (molecules that indicate how well you respond to study treatment) in your blood and/or tissue.

Participants will receive a dose of dalantercept or placebo (a substance with inactive drug that looks the same as dalantercept) plus axitinib. It is expected that a participant will be on this study for a variation of time (total duration will vary per subject).

Institution
MUSC
Recruitment Contact
Seth Price
843-792-1918
pricesr@musc.edu

Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with Breast Cancer Save

Date Added
May 6th, 2014
PRO Number
Pro00034370
Researcher
James Bearden
Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery.

MRI is a medical imaging method that uses magnets to make images of the body. MRI helps doctors to tell the difference between cancer and normal tissue in the body. MRI uses dyes (?contrast agents?) that are injected into the veins to help create the images of the body?s tissues.

Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves our ability to evaluate tumors and decide what kind of surgery is best for the patient.

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

Pro00029498; Baxalta 261302: A Phase 3b Continuation study of the Safety and Efficacy of PEGylated Recombinant Factor VIII (PEG-rFVIII; BAX 855) in Prophylaxis of Bleeding in Previously Treated Patients with Severe Hemophilia A Save

Date Added
March 10th, 2014
PRO Number
Pro00029498
Researcher
James French
Keywords
Blood Disorders, Drug Studies
Summary

A Phase 3b Continuation study of the Safety and Efficacy of PEGylated Recombinant Factor VIII (PEG-rFVIII; BAX 855) in Prophylaxis of Bleeding in Previously Treated Patients with Severe Hemophilia A

The purpose of this study is to continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patient (PTPs) aged less than or equal to 75 years of age with severe hemophilia A.

Patients with severe hemophilia A transitioning from other BAX 855 studies may be eligible for this study. Patients with severe hemophilia A who are BAX 855 na

Institution
Palmetto
Recruitment Contact
James French
803-434-3533
Selena.Lollar@PalmettoHealth.org

Gabapentin for Relapse Prevention: Alcohol Withdrawal-Brain GABA/Glutamate Effects Save

Date Added
March 4th, 2014
PRO Number
Pro00032587
Researcher
Raymond Anton
Keywords
Alcohol, Brain, Drug Studies, Stage III, Substance Use
Summary

This treatment study is an16-weeks outpatient clinical trial where subjects will get medication, which might help them to reduce or stop their drinking or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a ?sugar pill?). This study will recruit and randomize subjects who have expressed an interest in receiving treatment for alcohol dependence. Upon enrollment into this study there will be 11 outpatient visits. Each visit will last about 1-1.5 hours.

Institution
MUSC
Recruitment Contact
Konstantin Voronin
843-792-4887
voronin@musc.edu

A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC) Save

Date Added
February 4th, 2014
PRO Number
Pro00032186
Researcher
Patricia Griffin
Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

Cancer is a disease caused by alterations in the functions of genes within the cells. In approximately 15% of patients with non-small cell lung cancer, one of two genes is altered significantly (known as EGFR mutation or ALK rearrangement). Erlotinib, a pill, taken on a daily basis produces significant decrease in the size of tumors in patients with advanced stage lung cancer with EGFR mutation. Similarly, another pill, crizotinib, produces significant decrease in the size of tumors in patients with advanced stage lung cancer with ALK rearrangement. However it is not clear how useful these two drugs will be in patients with a less advanced form of lung cancer in the presence of these gene alterations.

The purpose of this study is to find out what effects, good and/or bad, one of the following treatments have on locally advanced, non-operable lung cancer with specific gene alterations (EGFR mutation or ALK rearrangement).

If the tumor has EGFR mutation, subjects will be randomized to either
? Standard treatment: radiation therapy and chemotherapy
or
? Experimental treatment #1: erlotinib for three months, then radiation therapy and chemotherapy

If the tumor has ALK rearrangement, subjects will be randomized to either
? Standard treatment: radiation therapy and chemotherapy
or
? Experimental treatment #2: crizotinib for three months, then radiation therapy and chemotherapy

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

Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and Stage II Classical Hodgkin Lymphoma (HL) Save

Date Added
January 7th, 2014
PRO Number
Pro00031502
Researcher
Asim Pati
Keywords
Cancer, Cancer/Lymphoma, Drug Studies
Summary

This phase II clinical trial is studying how well response-based therapy assessed by PET scan works in treating patients with bulky stage I and stage II Hodgkin lymphoma. PET scans will be obtained during the course of therapy. Researchers will evaluate the usefulness of this PET scan to determine whether radiation may be left out in the treatment of disease if the PET scan shows a response to chemotherapy alone. In addition, a small percentage of patients may have disease that is not adequately treated with ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and radiotherapy. Researchers hope to identify this group of patients using early PET scans and will change to a chemotherapy treatment called BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone).

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

An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients with Stable, Quiescent Systemic Lupus Erythematosus (SLE) Save

Date Added
December 17th, 2013
PRO Number
Pro00028738
Researcher
Diane Kamen
Keywords
Autoimmune disease, Drug Studies, Lupus
Summary

This study is designed to look at the safety of taking patients whose lupus is not active off the immune suppression medication, Mycophenolate. It will involve two groups of lupus patients. One group will continue taking Mycophenolate Mofetil (MMF), and the other group will taper off their MMF. Both groups will be followed closely by study doctors to determine their lupus activity levels over the course of 16 months.

Institution
MUSC
Recruitment Contact
Margaret Lindemuth
843-792-8613
hardinm@musc.edu

An Open Label study to examine the effects of DAS181 administered by Nebulized formulation in Immunocompromised subjects with Parainfluenza (PIV) Infection post study participation in PIV protocol DAS181-2-05 Save

Date Added
December 10th, 2013
PRO Number
Pro00029144
Researcher
Michelle Hudspeth
Keywords
Drug Studies, Immune System, Pediatrics, Pulmonary
Summary

The purpose of this research study is to test the safety, effectiveness and tolerability of an investigational drug called DAS181 on subjects with a very weak immune system who are diagnosed with PIV. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). DAS181 can be administered as a reconstituted dry powder that is breathed into the respiratory tract (nose, throat and lungs) using a liquid aerosol spray administered using a nebulizer. A nebulizer is an electrically powered machine that turns liquid medication into a mist so that it can be breathed directly into the lungs through a face mask or mouthpiece.

Institution
MUSC
Recruitment Contact
Mohammed Al Gadban
843-792-4837
algadban@musc.edu

A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma Save

Date Added
September 19th, 2013
PRO Number
Pro00029068
Researcher
James Bearden
Keywords
Cancer, Cancer/Brain, Drug Studies
Summary

The purpose of this study is to:
? See if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in patients who have been diagnosed with cancer and are experiencing fatigue.
? See the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue.

In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent). They will not take both.

Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders. However, it is not been studied in people with cancer related fatigue.

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

A Phase 1B Open-Label Three-Arm Multi-Center Study to Assess the Safety and Tolerability of PF-05212384 (PI3K/mTOR Inhibitor) in Combination with Other Anti-Tumor Agents Save

Date Added
August 27th, 2013
PRO Number
Pro00027912
Researcher
Carolyn Britten
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is enrolling male and female patients with a diagnosis of advanced solid tumor. The purpose of this research study is to learn about the effects of and to find the best dose of the study drug, PF 05212384, when given in combination with other drugs. This study will determine the highest dose of PF-05212384 that can be tolerated when given in combination with other drugs; this PF-05212384 dose is called the maximum tolerated dose or MTD. Enrolled patients can expect to be in this study for about 6 months. They will need to visit the research site at least 12 times during the study. Patients may stay in the study until the disease gets worse or they decide to stop participating.

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

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