A Pilot Study to Evaluate the Safety and Preliminary Evidence of an Effect of ODSH (2-O, 3-O Desulfated Heparin) in Accelerating Platelet Recovery in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia Save

Date Added
January 14th, 2014
PRO Number
Pro00031445
Researcher
Alice Mims
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of the study is to see whether or not the drug ODSH prevents thrombocytopenia (a condition in which there is a lower-than-normal number of platelets in the blood) of Acute Myeloid Leukemia (AML) patients getting induction and consolidation chemotherapy. The drug ODSH is an experimental drug and is not approved by the FDA. ODSH is a derivative of the blood thinner heparin with diminished blood thinning properties. ODSH has been studied in subjects with chronic obstructive pulmonary disease (COPD) and is being studied in pancreatic cancer in combination with chemotherapy.
This is a “Pilot Study”. This means that the study will involve a small number of patients and will gather preliminary results. This study will also look at whether ODSH increases the remission rate when combined with chemotherapy for AML and will look at the safety of ODSH in combination with AML chemotherapy.
A total of 10 subjects will be enrolled nationwide. About 3 of those subjects will be enrolled at MUSC under the care Alice Mims, MD.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-7463
salzers@musc.edu

A Phase Ib, multi-center, two parallel group, open-label, drug-drug interaction study to assess the effect of LDE225 on the pharmacokinetics of bupropion and warfarin in patients with advanced solid tumors Save

Date Added
January 14th, 2014
PRO Number
Pro00022678
Researcher
Carolyn Britten
Keywords
Cancer, Cancer/Myeloma
Summary

Subjects are being asked to participate in this study to find out if the drug LDE225 is safe and has beneficial effects in people who have advanced solid tumors.

When subjects decide to participate, they will be asked to come to the study site to see if they are eligible to participate in the study (1-3 hour visit). If they are eligible for the study, they may be asked to come to the study site for an overnight stay, and then return every 24 hours for the next 6 days (1 hour visits). On the 6th day, they will begin the first of 6 (or more if you continue to have benefit from the drug) cycles that will last 28 days. During the first cycle you will return on days 8, 15 and 22. During Cycle 2, subjects may repeat the overnight stay at Day 21 to 23. They will then return once a day for the next 5 days. During Cycle 3, subjects will have 2 visits on day 1 and 15. Starting at cycle 4 and for the rest of the cycles they will have 2 visits on day 1 and 28. After a subject completes treatment, they will have an End of Treatment visit, followed by a safety follow up visit 30 days later.

Subjects will be asked to come to the doctor’s clinic 35 times over about 220 days. Each visit should take about 1 to 2 hours. If subjects continue to benefit from the study drug, they may continue your treatment with visits on day 1, 15 and 28 of each 28 day cycle.

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

PHASE 2 SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF BRENTUXIMAB VEDOTIN IN COMBINATION WITH BENDAMUSTINE IN PATIENTS WITH RELAPSED OR REFRACTORY HODGKIN LYMPHOMA (HL) Save

Date Added
January 14th, 2014
PRO Number
Pro00031490
Researcher
Robert Stuart
Keywords
Blood Disorders, Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for adult patients that have been diagnosed with relapsed or refractory Hodgkin lymphoma (HL). The purpose of this study is to gather information about the effectiveness and safety of a drug called brentuximab vedotin when given in combination with another drug called bendamustine for Hodgkin lymphoma. Patients will receive the study drug on day one of a 21-day cycle for up to 16 cycles. Participants will have follow-up visits approximately every 3 months for the first year. Then the visit will be approximately every 6 months for two years.

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

A Phase 1A/1B, Multi-Center, Open-Label, Dose Finding Study to Assess The Safety, Tolerability, Pharmacokinetics And Preliminary Efficacy Of The Pleiotropic Pathway Modifier CC-122 Administered Orally To Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma Or Multiple Myeloma Save

Date Added
January 14th, 2014
PRO Number
Pro00022374
Researcher
Carolyn Britten
Keywords
Cancer, Cancer/Brain, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Lymphoma, Cancer/Myeloma
Summary

This study is for subjects that have cancer that has spread or that cannot be cured by surgery, drugs, or any other known treatments. The main purpose of this study is to test the safety of a new experimental drug called CC-122, a Pleiotropic Pathway Modulator (PPM). Pleiotropy refers to a case where one gene may influence several other characteristics or may have multiple effects in numerous tissues. CC-122 belongs to a new class of drugs called “PPMs.” These drugs affect how the immune system works, slow the growth of tumor cells and block blood vessel growth in tumors. Approximately 100 people will take part in this study. The goal of this study is to test the highest, and/or the near-highest tolerated dose level. It may be necessary to test more than one dose level. This study will take place in the United States and in countries in Europe. This study will take about 18 to 24 months to complete. This study is only open to certain types of cancer including: (1) locally advanced (including inflammatory) breast cancer (LABC), (2) hepatocellular carcinoma (HCC), (3) certain types of brain tumor called glioblastoma multiforme (GBM), (4) multiple myeloma (MM), and (5) diffuse large B-cell lymphoma (DLBCL).

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9700
brisend@musc.edu

An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS 003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT) Save

Date Added
January 10th, 2014
PRO Number
Pro00021461
Researcher
Harry Drabkin
Keywords
Cancer, Men's Health, Women's Health
Summary

This study is for subjects with newly diagnosed advanced kidney cancer who have previously consented to allow for collection of a tumor sample, which may be used to make a personalized experimental drug called AGS-003. Argos Therapeutics is sponsoring this research study using their experimental (investigational) drug AGS-003 to see if it is effective against kidney cancer. An investigational drug is a medication that is still being studied and has not been approved for use in the general population by the United States Food and Drug Administration (FDA). AGS-003 is made for subjects by using a piece of tumor collected after surgical removal of their kidneys along with a certain type of their own white blood cells. The resulting product is a type of immune cell called a dendritic cell, which is very good at activating the immune system against cancer cells.
AGS-003 can be used in combination with the approved, regular medications most often prescribed for the treatment of kidney cancer. In this study, one group of subjects will receive regular medications for kidney cancer and a second group will receive regular medications for kidney cancer plus AGS-003. An important purpose of this study is to see if treatment with AGS-003 plus regular medications is any different than treatment with regular medications alone. Subjects are expected to be enrolled in this study for approximately 3 years.

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

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
Charles Bowers
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

The Lymphedema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients Save

Date Added
January 7th, 2014
PRO Number
Pro00023757
Researcher
David Griffin
Keywords
Cancer, Cancer/Gynecological, Non-interventional
Summary

The purpose of this study is to find out how often woman with gynecologic cancer may develop lower extremity lymphedema (swelling in the legs or a swollen leg) after undergoing surgery to remove the tumor and surrounding tissue.

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

A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of Genetics Services Among Breast Cancer Patients Save

Date Added
January 6th, 2014
PRO Number
Pro00031154
Researcher
Amarinthia Curtis
Keywords
Cancer, Cancer/Breast, Genetics
Summary

The purpose of this study is to see if providing education to healthcare providers can improve referral for genetic counseling for those patients with breast cancer who have hereditary cancer risk (some women with breast cancer have hereditary cancer risk, most do not).

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

A PHASE III TRIAL OF ADJUVANT CHEMOTHERAPY AS PRIMARY TREATMENT FOR LOCALLY ADVANCED CERVICAL CANCER COMPARED TO CHEMORADIATION ALONE: THE OUTBACK TRIAL (ANZGOG 0902/GOG-0274/RTOG 1174) Save

Date Added
December 18th, 2013
PRO Number
Pro00016094
Researcher
Jennifer Young
Keywords
Cancer, Cancer/Gynecological
Summary

The objectives of this trial are to find out whether adjuvant chemotherapy (using two other drugs) after chemo-radiation will increase the chances of survival and reduce the risk of tumor recurrence in the pelvis and other places. The risk and severity of side effects and quality of life during and after treatment will also be evaluated and compared. This trial will help the researchers understand the safety and effectiveness of this new treatment regimen for cervical cancer.

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

Exploration of the Association of Periodontal Disease and Colon Neoplasia Save

Date Added
December 17th, 2013
PRO Number
Pro00011920
Researcher
Jing Zhou
Keywords
Cancer, Colonoscopy, Periodontal Disease
Summary

This is a pilot study to determine the association of periodontal disease and colon neoplasia. Previous studies have suggested that chronic inflammation may play a role in colorectal cancer onset. Periodontal disease is a major chronic inflammation in an otherwise healthy individual. A correlation between periodontal disease and colorectal cancer has also been reported in previous epidemiology studies. In order to confirm this association, and to explore the link between these two conditions, we designed this case-control study. The central hypothesis is that there is a higher prevalence of periodontal disease, more periodontal tissue destruction, and altered levels of salivary and blood biomarkers from periodontal disease in patients with colon neoplasia.

Institution
MUSC
Recruitment Contact
Lynn West
8437926101
westjl@musc.edu