A Safety Study For MSB0010445 In Combination With Stereotactic Body Radiation In Advanced Melanoma Subjects Following Prior Treatment With Ipilimumab Save

Date Added
February 26th, 2015
PRO Number
Pro00032178
Researcher
Keisuke Shirai
Keywords
Cancer, Men's Health, Skin, Women's Health
Summary

The purpose of this study is to target the tumor sites in subjects with advanced melanoma that are affected during radiation and to create an immune response (the activity of the immune system against foreign substances) that would potentially destroy surrounding tumors and microscopic disease with fewer harmful effects than other similar drugs.
In this research study, MSB0010445, the drug being developed, will be given in combination with Stereotactic Body Radiation Therapy (SBRT, a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body). Radiotherapy is an integral part of the management of advanced melanoma. It provides local tumor control and improvement of symptoms.
The subject will be assigned to 1 of 3 dose groups (low dose group, intermediate dose group, or high dose group). Each dose group will receive a different dose level of the study drug. The group to which the subject will be assigned will depend on when they enter the study.

Institution
MUSC
Recruitment Contact
Scott Landreth
843-792-6429
landrets@musc.edu

A Multi-Center, Open-Label, First-in-Human, Phase I Dose-Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6839921, An MDM2 Antagonist, Following Intravenous Administration in Patients with Advanced Malignancies, including Acute Myeloid Leukemia (AML) Save

Date Added
February 24th, 2015
PRO Number
Pro00033053
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

This study involves the use of RO6839921, a new investigational drug, which means that it has not been approved by the Food and Drug Administration (FDA). This is the first study using RO6839921 in humans. However in animal studies, RO6939921 has demonstrated the ability to kill cancer cells.
At least 3 patients will participate in the initial phase of this study and will be referred to as “Cohort 0”. The patients in Cohort 0 will be given RO6839921 for one cycle of 28 days. After these patients have completed one cycle, the study will be stopped and all of the data from these patients will be reviewed very carefully with the FDA. Once the FDA says it is OK with the results following the treatment of patients in Cohort 0, more patients will be able to join the study. This study will look for the highest safe dose of RO6839921 that can be given to patients with solid tumor cancer (Arm A) or acute myelogenous leukemia (AML) (Arm B). Any side effects associated with the use of RO6839921 will be carefully monitored by your study doctor.

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

RANDOMIZED PHASE II TRIAL OF CONCURRENT BEVACIZUMAB AND RE-IRRADIATION VERSUS BEVACIZUMAB ALONE AS TREATMENT FOR RECURRENT GLIOBLASTOMA Save

Date Added
February 17th, 2015
PRO Number
Pro00023155
Researcher
Scott Lindhorst
Keywords
Cancer, Cancer/Brain, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have a brain tumor, called a glioblastoma or gliosarcoma, which has become worse after previous treatment. The purpose of this study is to determine whether adding radiation to bevacizumab is more effective than using bevacizumab alone to treat recurrent glioblastomas.
In this trial patients will be randomly assigned to receive either bevacizumab alone or bevacizumab and radiation therapy.If you are in Group 1, you will be asked to take bevacizumab alone every two weeks as long as it is working and there are no intolerable side effects. If patients are assigned to Group 2, he/she will take bevacizumab 2 weeks before radiation therapy, during radiation therapy, and then every 2 weeks after radiation therapy as long as it is working and there are no intolerable side effects. The radiation will be given to participants over 2 weeks. Participants will be followed every 8 weeks while on treatment and then also if participants are removed from protocol treatment. Follow-up will continue every 8 weeks for 1 year, then every 6 months for 1 year, then annually.

Institution
MUSC
Recruitment Contact
John Keller
843-792-1286
kellej@musc.edu

Collection of Whole Blood Specimens from Pregnant Women at Increased Risk for Fetal Chromosomal Abnormality for use in Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted from Maternal Plasma Save

Date Added
February 10th, 2015
PRO Number
Pro00010416
Researcher
Charles Rittenberg
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

This is a multicenter, observational study.

This research study will test whether the methods being developed for the detection of fetal abnormality from samples of maternal blood can be used in the laboratory and employed in clinical practice

Institution
MUSC
Recruitment Contact
Betty Oswald
843 792 0347
oswaldbw@musc.edu

A Phase 2 Randomized Open-label Study of MEDI-551 in Adults With Relapsed or Refractory DLBCL Save

Date Added
January 29th, 2015
PRO Number
Pro00032805
Researcher
Robert Stuart
Keywords
Blood Disorders, Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study if for adults with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). This is a research study of an experimental drug, called MEDI 551. MEDI-551, the experimental study medication in this study, is an antibody which attaches to CD19 on the outside of the B-cells. Once attached, MEDI-551 causes the B-cells to die. MEDI 551 is being studied to see if it might slow the cancer’s growth or stop it from spreading to other parts of the body. In this study, MEDI-551 will be examined in combination with either ICE or DHAP to see how this compares to the rituximab in combination with either ICE or DHAP therapy in terms of slowing down the growth of your cancer or bringing the cancer into remission. For patients who are eligible for this study, the duration of participation may include up to a 28 day screening period, up to 70 days for the treatment period, and a 90 day safety follow-up period and a post-safety follow-up period. The treatment period may consist of up to 3 (each cycle is 21 days) cycles of treatment (either MEDI-551 + ICE/DHAP or rituximab + ICE/DHAP) unless the disease progresses, or the participant experience unacceptable side effects, or the participant withdrawal for other reasons in which case they may receive less than 3 cycles of therapy.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@Musc.edu

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder Save

Date Added
January 27th, 2015
PRO Number
Pro00030278
Researcher
Steven Swift
Keywords
Bladder, Obstetrics and Gynecology, Women's Health
Summary

The purpose of this study is to examine how well two medicines given together (solifenacin succinate and mirabegron) work in the treatment of overactive bladder problems (such as frequency and urgency) over an 18-week period. Both these medications have already been shown to be well tolerated and effective in treating OAB if given separately.

Institution
MUSC
Recruitment Contact
Betty Oswald
843-792-0347
oswaldbw@musc.edu

A Phase II, Multicenter, Randomized, Observer-Blind, Controlled Study to Evaluate Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women Save

Date Added
January 27th, 2015
PRO Number
Pro00029481
Researcher
David Soper
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

Norvartis Vaccines and Diagnostics (NVD) is studying a vaccine for the prevention of Group B streptococcus (GBS) disease in babies. This is a common disease passed along to baby during birth, and that the purpose of the vaccine is to prevent this from happening, keeping baby from getting a GBS infection. This study is being conducted to learn more about the safety and immune response (how the vaccine works) of the vaccine in pregnant women and their babies.

Institution
MUSC
Recruitment Contact
Betty Oswald
843.792.0347
oswaldbw@musc.edu

A Multicenter Phase 2 Study of Single-agent Filanesib (ARRY-520) in Patients With Advanced Multiple Myeloma Save

Date Added
January 27th, 2015
PRO Number
Pro00038866
Researcher
Saurabh Chhabra
Keywords
Cancer, Cancer/Myeloma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with multiple myeloma that have not responded to standard cancer treatments. The investigational drug in this study is filanesib. The purpose of the study is to see if filanesib has beneficial effects on subjects with multiple myeloma. The study will also measure the levels of a protein called AAG in patient blood samples to see if the amounts of AAG can predict whether a patient will benefit from filanesib. Participants can expect to be in the study until they decide to stop, have unacceptable side effects, disease gets worse, become pregnant or are breastfeeding (for females only) or the study doctor decides it is best to stop.

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

Anthropometric findings as predictors for gestational diabetes and pre-eclampsia. Save

Date Added
January 21st, 2015
PRO Number
Pro00038288
Researcher
Yeonjung Park
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

This study will be looking to determine if specific clinical signs found in pregnant women (skin tags and darkended areas of skin) may be associated with a greater risk of a pregnant woman developing gestational diabetes and preeclampsia.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon-Osaboma
843.792.6323
yeadon@musc.edu

Structural Artery Defects at the Utero-placental Unit in Preeclampsia Save

Date Added
January 20th, 2015
PRO Number
Pro00040396
Researcher
Julio Mateus nino
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to learn more about blood vessel defects in the placental bed and in the placenta of women who have pregnancies that are complicated by preeclampsia.

Institution
MUSC
Recruitment Contact
Tamara Saunders
843.792.6992
saundert@musc.edu