A Phase 1/2 Study of CNDO-109-Activated Allogeneic Natural Killer Cells in Patients with High-Risk Acute Myeloid Leukemia in 1st Complete Remission (CR1) Save

Date Added
September 9th, 2014
PRO Number
Pro00016987
Researcher
Robert Stuart
Keywords
Cancer, Drug Studies, Men's Health, Transplant, Women's Health
Summary

The main purpose of this study is to evaluate CNDO-109 Activated Allogeneic Natural Killer Cells (NK Cells) and how participants with Acute Myeloid Leukemia (AML) respond when given this therapy. The primary objective of this study is to define the maximum tolerated dose (MTD), or the maximum tested dose of CNDO-109-Activated Allogeneic Natural Killer cells infused (given) after preparative chemotherapy. NK cells are a type of blood cell in your immune system that attack cancer cells.

Institution
MUSC
Recruitment Contact
Jessica Simons
846-792-8856
simonsj@musc.edu

A PhaseI/II Adaptive Randomized Trial of Bevacizumab versus Bevacizumab plus Vorinostat in Adults with Recurrent Glioblastoma Save

Date Added
August 26th, 2014
PRO Number
Pro00020172
Researcher
Scott Lindhorst
Keywords
Cancer, Men's Health, Women's Health
Summary

The goal of this Phase II part of this clinical research study is to learn if bevacizumab when given with or without vorinostat can help to control malignant gliomas. The safety of these drug combinations will also be studied. Vorinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die. Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
If the participants are found to be eligible to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. If they are in Group 1, they will take bevacizumab.If the participants are in Group 2, they will take vacizumab and vorinostat
The participant may take the study drug(s) for up to 1 year. Participation on this study will end once the participant completes the end-of-dosing visit and long-term follow-up.

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

A Randomized, Double Blind, Placebo-Controlled, Multicenter Phase II Study To Evaluate Efficacy And Safety Of Roniciclib In Subjects With Extensive-Stage Disease Small Cell Lung Cancer (SCLC) Who Are Receiving Cisplatin + Etoposide Or Carboplatin + Etoposide As First-Line Therapy Save

Date Added
August 26th, 2014
PRO Number
Pro00037205
Researcher
Keisuke Shirai
Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to see if subjects diagnosed with small cell lung cancer will benefit from treatment with a study drug called RONICICLIB in combination with chemotherapy.

Institution
MUSC
Recruitment Contact
Jason Dority
843-792-5853
dority@musc.edu

The Role of Human Chorionic Gonadotropin Supplementation in Oocyte Donor Ovarian Stimulation Save

Date Added
August 19th, 2014
PRO Number
Pro00034914
Researcher
John Schnorr
Keywords
Obstetrics and Gynecology, Women's Health
Summary

The purpose of this research study is to determine if adding a medication that is approved by the United States Food and Drug Administration (FDA) earlier in the normal ovarian stimulation regimen (process that is used by a doctor to help your body release a greater number of mature eggs than it would during a normal cycle) will help you release more eggs or help to lower the dose of hormones that are normally required to help your body release more eggs. This medication is called Human Chorionic Gonadotropin (hCG). hCG is a hormone that supports the normal development of an egg in a woman’s ovaries (the organs in the body that produce a woman’s eggs).

Institution
MUSC
Recruitment Contact
Holly Boggan
843.876.1434
bogganhl@musc.edu

Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Cancers (MIBC) Save

Date Added
August 19th, 2014
PRO Number
Pro00019998
Researcher
Virginia Herrmann
Keywords
Cancer, Cancer/Breast, Women's Health
Summary

This study is for patients with multiple ipsilateral breast cancers (MIBC). The purpose of this research study is to see if removing only the tissues from the 2 or 3 cancers in the patient's breast (breast conservation surgery) in combination with radiation to the breast, instead of removing the patient's entire breast (mastectomy) is safe in keeping the patient's cancer from coming back in the patient's breast. Patients will be asked to visit the study doctor for follow-up exams for up to 5 years after patients have completed WBI.

Institution
MUSC
Recruitment Contact
Katherine Halloran
843-792-7035
halloran@musc.edu

Improving Health Through Implementation of a Village-Based Complex Biogas System Save

Date Added
August 19th, 2014
PRO Number
Pro00034850
Researcher
Cynthia Swenson
Keywords
Children's Health, Disease Prevention, Men's Health, Women's Health
Summary

Lack of proper sanitation is one of the most significant and widespread health hazards in low and middle- income countries (LMIC). By the end of 2011, 2.5 billion people lacked access to hygienic means of personal sanitation. Further, 1 billion people (15% of the world’s population) lacked access to any facility and engaged in open defecation, a practice carrying enormous health risks. The problem is so widespread and life threatening that the United Nations identified improved sanitation in its millennium development goals for LMIC. One safe and environmentally sensitive solution that addresses the issue of human waste containment is a waste-to- energy system called a biogas system. Waste management biogas systems exist in Ghana but predominantly in large institutions; they have not been implemented in economically disadvantaged, rural communities (Bensah & Brew-Hammond, 2010). In fact, few sanitation systems of any kind exist in rural Ghana where the majority of the nation’s most economically disadvantaged live. The rural village of Okurase in the eastern region of Ghana and its supporting NGO have a longstanding relationship with MUSC. They propose to implement a biogas system that would reduce open defecation, reduce the use of charcoal and wood in cooking, and reduce the use of heavy chemicals in farming. A physicist and engineer have developed a method using a 3-prong approach that can be installed in the village. The Okurase Biogas System will include a private building with toilets. Human waste enters a chamber where it is converted to gas. This gas is harnessed as a dual energy source for cook stoves and organic fertilizer. The Chief and Elders of the village have embraced this technology and support its implementation. More information is needed to learn how to promote uptake of such a system by village residents. Therefore, in line with the overall goals for this village of developing a sustainable infrastructure to improve water, sanitation, health, economic self-sufficiency and food security in Okurase, the specific aims of this application are to: 1) determine the feasibility and acceptability of the biogas system; 2) assess the attitudes and knowledge of biogas technology over time; and, 3) determine factors that promote or preclude system sustainability.

Institution
MUSC
Recruitment Contact
Sarah Logan
843-693-2233
logans@musc.edu

Cervical Cancer Screening Among Lesbian and Bisexual Women Save

Date Added
August 15th, 2014
PRO Number
Pro00036905
Researcher
Michael Johnson
Keywords
Cancer, Cancer/Gynecological, Non-interventional, Obstetrics and Gynecology, Women's Health
Summary

Lesbian and bisexual women under utilize cervical cancer screening programs as compared to heterosexual women. This study uses interviews to explore, identify, and examine the factors that influence cervical cancer screening participation among lesbian and bisexual women. The findings from this study will generate new knowledge and enhance understanding of the cervical cancer screening among lesbian and bisexual women. The findings from this study can be used to design specific interventions to improve cervical cancer screening among lesbian and bisexual women.

Institution
MUSC
Recruitment Contact
Michael Johnson
702-301-1874
johnsmj@musc.edu

A Phase Ib/II, Multi-center, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects with Previously Untreated, Unresected, Stage IIIb-IV Melanoma Save

Date Added
August 12th, 2014
PRO Number
Pro00033373
Researcher
Keisuke Shirai
Keywords
Cancer, Drug Studies, Men's Health, Skin, Women's Health
Summary

The purpose of this study is to find out more about talimogene laherparepvec (formerly known as OncoVEXGM-CSF), in people with advanced melanoma when given in combination with another drug called ipilimumab.
Talimogene laherparepvec is a modified herpes simplex type-1 virus (the ‘cold sore’ virus) that has a medicine called human granulocyte macrophage colony-stimulating factor (GM-CSF) added to it. Human GM-CSF is a medicine used to treat patients with white blood cell counts that are low. Talimogene laherparepvec is still experimental and is not approved by the FDA.

Institution
MUSC
Recruitment Contact
Jason Dority
843-792-6429
dority@musc.edu

A Multi-Arm Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Dual PI3K/mTOR Inhibitors PF-04691502 and PF-05212384 in Combination with Experimental or Approved Anticancer Agents in Patients with Advanced Cancer. Save

Date Added
August 12th, 2014
PRO Number
Pro00028355
Researcher
Carolyn Britten
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for adult males and females who have been diagnosed with cancer. This study involves a new investigational drug called PF-05212384 that is currently not FDA-approved for sale in this country. The first goal of this study is to determine the highest dose of PF-05212384 that can be tolerated without endangering the patients (MTD). When the MTD is found, additional patients will be enrolled to the study to examine the safety and tolerability of PF-05212384 in combination with other study drugs. Each participant will receive only one of the two possible combinations described below of study drugs while in this study. Patients may be in this study for approximately up to 1 year. Depending on the treatment he/she is given, he/she may need to visit the clinic daily, after the initial dose period. The visits to the clinic may then be as much as every 4-6 days during the first 6 “cycles” (each cycle is approximately 28 days) of treatment.

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

A Phase 1 Trial of SGN-CD70A in Patients with CD70-Positive Malignancies Save

Date Added
August 12th, 2014
PRO Number
Pro00036276
Researcher
Alice Mims
Keywords
Cancer, Men's Health, Women's Health
Summary

This clinical trial uses an investigational drug called SGN-CD70A in patients that have Non-Hodgkin lymphoma (NHL) or renal cell carcinoma (RCC). This study is being done to find out what side effects (unwanted effects) are caused in subjects with NHL or RCC who are given SGN-CD70A. This study will also look at other effects of SGN-CD70A, including its effect on the subject's cancer.
Subjects will be enrolled to receive low doses of SGN-CD70A in the beginning. If the subjects given low doses do not have bad side effects, the next subjects will be given a higher dose of SGN-CD70A. After this, subjects just starting SGN-CD70A will be given higher or lower doses, depending on the side effects subjects have already had. This will continue until the highest dose of SGN-CD70A that does not cause bad side effects is found.
Approximately 95 people will take part in this research study.

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