Roles of intratumor macrophages and the master chaperone for Toll-like receptors in colon cancer Save

Date Added
October 24th, 2014
PRO Number
Pro00010913
Researcher
Zihai Li
Keywords
Cancer, Cancer/Other, Men's Health, Minorities, Non-interventional, Surgery, Women's Health
Summary

This study will help to understand the roles of the immune system in controlling colon cancer. It may advance science, leading to future development of an effective treatment of colon cancer.

Institution
MUSC
Recruitment Contact
Zihai Li
843-792-1034
zihai@musc.edu

A Phase II Multi-Center Study of Bevacizumab in Combination with Ixabepilone in Subjects with Advanced Renal Cell Carcinoma. Save

Date Added
October 21st, 2014
PRO Number
Pro00027639
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients with advanced renal cell carcinoma. This is a Phase II study for the experimental treatment of kidney cancer. The drugs to be examined in this study are a combination of ixabepilone and bevacizumab. The purpose of this phase II study is to determine whether the combination of ixabepilone administered for five consecutive days and bevacizumab administered on one day, both repeated every three weeks, is effective in the treatment of kidney cancer.

Institution
MUSC
Recruitment Contact
Seth Price
843-792-6969
pricesr@musc.edu

Randomized Phase II Trial of Individualized Adaptive Radiotherapy Using During-Treatment FDG-PET/CT and Modern Technology in Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Save

Date Added
October 21st, 2014
PRO Number
Pro00026773
Researcher
James Ravenel
Keywords
Cancer, Cancer/Lung, Lung, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with lung cancer who cannot have surgery because of the location of or advanced stage of the cancer or other serious health problems such as emphysema, diabetes, or heart disease. The purpose of this study is to find out if more intense (higher dose) radiation treatment based on the FDG-PET/CT imaging improves treatment of this cancer with the same possible damage to healthy lung tissue compared to treatment with standard radiation therapy. The higher dose radiation is aimed at the tumor. Patients will be randomized into one of two groups; Group A will receive standard radiation treatment once daily, 5 days a week for 5 weeks. They will also will receive chemotherapy (paclitaxel and carboplatin), once a week for 6 weeks. Group B will receive radiation treatment once daily, 5 days a week for 3-4 weeks. This radiation treatment will be a higher dose per day than standard radiation. Patients will also receive chemotherapy (paclitaxel and carboplatin), once a week for 6 weeks. Both groups will receive Paclitaxel and carboplatin are given by vein before radiation therapy. Both groups will also receive paclitaxel and carboplatin by vein every 21 days X 3, a total of 3 cycles of chemotherapy four to six weeks after radiation treatment is completed.

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

Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (R05185426) Adjuvant Therapy in Patients with Surgically-Resected Cutaneous BRAF Mutant Melanoma at High Risk for Recurrence Save

Date Added
October 17th, 2014
PRO Number
Pro00021186
Researcher
Keisuke Shirai
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to find out whether vemurafenib can help prevent or delay the return of melanoma that is at a high risk of returning (Stage IIC, IIIA, IIIB or IIIC) after it has been removed surgically. The study will also assess whether the drug causes side effects in patients.
Vemurafenib was recently approved in the United States for the treatment of patients with metastatic melanoma. Vemurafenib remains an investigational drug being studied by Roche.

Institution
MUSC
Recruitment Contact
Robin Bostick
843-792-8876
bostickr@musc.edu

A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0010718C in subjects with metastatic or locally advanced solid tumors and expansion to selected indications. Save

Date Added
October 14th, 2014
PRO Number
Pro00030051
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

The main purpose of this research trial is to test the investigational drug MSB0010718C at different dose levels to see if it is safe and well tolerated when given once every two weeks. Based on this information the sponsor of this study hopes to learn which dose (drug strength) could be best for treatment of subjects.
Additional purposes of the trial are to assess side effects of MSB0010718C and to find out whether MSB0010718C has anti-cancer effects. In addition, the sponsor would like to find out how MSB0010718C is processed by the body (this is called pharmacokinetic or PK research).
Approximately 380 people will participate in the expansion part of the trial. The research trial will be conducted in up to 130 medical centers in the US and Europe. About 10 of those patients will be enrolled at MUSC under the care of Carolyn Britten, MD.

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

A Phase I-II trial of Everolimus and Sorafenib in Patients with Recurrent High-Grade Gliomas Save

Date Added
October 9th, 2014
PRO Number
Pro00021241
Researcher
Scott Lindhorst
Keywords
Cancer, Men's Health, Women's Health
Summary

This study is being performed in patients who have malignant glioma (which includes different types of glioma called “glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma) that has gotten worse after previous treatment or is getting worse despite treatment. There are two phases to this study:
The goal of Phase I of this clinical research study is to find the highest tolerable dose and best schedule of the combination of everolimus and sorafenib that can be given to patients with malignant glioma.
The goal of Phase II of this study is to learn if the combination of everolimus and sorafenib can help control malignant glioma. The safety of this combination will also be studied in both phases.
Sorafenib is designed to stop cell growth and to block the formation of new blood vessels (the tubes that carry blood around the body), which are involved in the growth and development of tumors.
Everolimus is designed to block a special protein in tumor cells and block the formation of new blood vessels, which is important in tumor growth.

Institution
MUSC
Recruitment Contact
Michele DeCandio
843-792-9016
decandio@musc.edu

Efficacy of labor epidurals for postpartum tubal ligation: Effect of postpartum epidural saline infusion on the reactivation of labor epidurals for postpartum tubal ligation following vaginal delivery Save

Date Added
September 16th, 2014
PRO Number
Pro00033454
Researcher
Laura Roberts
Keywords
Obstetrics and Gynecology, Women's Health
Summary

Numerous women desire tubal ligation following vaginal delivery for birth control. Many women also have an epidural placed for pain control during labor. Ideally, an epidural catheter placed for labor can also be used to provide anesthesia for a subsequent tubal ligation procedure. Research shows that a percentage of epidural catheters function poorly and are not sufficient for anesthesia for tubal ligation following labor and delivery. This study will test whether an infusion of preservative-free saline (salt-water) in the epidural will decrease the number of labor epidurals that function poorly or not at all, and thereby, decrease the need for additional procedures (a spinal or general anesthetic) to provide anesthesia for post partum tubal ligation.

Institution
MUSC
Recruitment Contact
Wanda Jones
843-792-1869
joneswr@musc.edu

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 Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Azacitidine with or without Birinapant with a Single Arm Open-Label Run-In Phase in Subjects with Higher Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia. Save

Date Added
August 26th, 2014
PRO Number
Pro00036608
Researcher
Alice Mims
Keywords
Cancer, Cancer/Leukemia, Drug Studies, Men's Health, Women's Health
Summary

This study is a Phase IIa and IIb for patients that have been diagnosed with with myelodysplastic syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMMoL). The investigational drug in this study is Birinapant. The purpose of this research study is to obtain further information about the safety and efficacy (how well it works) of azacitidine plus birinapant (the investigational drug), in Subjects with higher-risk myelodysplastic syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMMoL).

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