A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NCS# 123127) v. Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma + save

Date Added
October 17th, 2013
PRO Number
Pro00026910
Researcher
Jennifer Young
Keywords
Cancer, Cancer/Gynecological
Summary

This study is for patients who have a specific kind of uterine cancer; called a leiomyosarcoma that was found only in the uterus; and which has been completely removed by surgery. In this study, we are looking to see if giving chemotherapy with gemcitabine plus docetaxel, followed by doxorubicin, to patients whose leiomyosarcoma was found only in the uterus, decreases the chance that the leiomyosarcoma will come back (recur). In this study half the patients will be managed in the standard way, which is to follow them closely with CT scans, and see if the disease ever comes back. The other half of the patients will be treated with chemotherapy and also followed to see if the disease comes back. Patients will be asked to visit the office for follow up exams approximately every four months for the first three years and then every six months for the next two years after enrollment on this study. At the end of this five year period we would like to keep track of the participants' medical condition for the rest of their lives by calling once a year to see how they are doing.

Institution
MUSC
Recruitment Contact
Anne Wulf
843-792-9190
wulf@musc.edu

Accruing Preliminary Data towards Testing the Hypothesis that Manual Therapy (Therapeutic Massage) Ameliorates Signs, Symptoms and Quality of Life Issues Associated with Chemotherapy-Induced Peripheral Neuropathy + save

Date Added
October 15th, 2013
PRO Number
Pro00013281
Researcher
Teresa Kelechi
Keywords
Cancer, Complementary Medicine, Nerve, Pain
Summary

This small feasibility study explores the use of manual therapy (therapeutic massage) as a treatment for the sensory elements of chemotherapy-induced peripheral neuropathy (CIPN). The sensory elements include pain, numbness and tingling in the feet and sometimes also the hands.

One purpose is to obtain preliminary assessments of impacts of manual therapy on the signs and symptoms of CIPN, and quality of life (QoL). We will also measure the impacts of manual therapy on blood flow in the skin of the extremities (primarily the feet), and compare this with changes in CIPN signs and symptoms. All of these assessments are completely non-invasive. Another purpose is to pilot and refine the procedures and data collection.

This information will be use to design a clinical trial to test the effectiveness of manual therapy to treat the sensory elements of CIPN.

Institution
MUSC
Recruitment Contact
Teresa Kelechi
843-792-4602
kelechtj@musc.edu

A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women with Early Stage Breast Cancer + save

Date Added
October 15th, 2013
PRO Number
Pro00028948
Researcher
Joanna Metzner-sadurski
Keywords
Cancer, Cancer/Breast
Summary

The purpose of this study is to assess the effects, good and/or bad, of the medication duloxetine compared to placebo (contains no active ingredient) on joint pain that is associated with taking aromatase inhibitors. Duloxetine is usually prescribed to treat depression or anxiety, pain caused by nerve damage or fibromyalgia (a painful muscle/bone/nerve disorder) and a muscle and bone pain from a type of arthritis. Researchers on this study want to see if the pain relieving effects of the drug work for this type of pain.

Institution
MUSC
Recruitment Contact
Kelly Hawthorne
864-725-7129
khawthorne@selfregional.org

Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients with Advanced Cancer + save

Date Added
October 15th, 2013
PRO Number
Pro00020929
Researcher
Michael Lilly
Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Lung, Cancer/Lymphoma, Cancer/Other
Summary

This study is for subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes). The overall goal of this study is to identify plant-derived phytochemicals that can safely reduce systemic inflammation (inflammation throughout the entire body) in subjects with advanced cancer. The term "phytochemicals" refers to a wide variety of compounds produced by plants. They are found in fruits, vegetables, beans, grains, and other plants. This study will look at oligomeric procyanidin complex (OPC) and vitamin D3. OPC is the major part of Grape Seed Extract. Subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes) will receive grape seed extract alone once or twice a day for 21 days. Then subjects will begin taking Vitamin D-3 at a fixed dose for 42 days. It is anticipated that this study may last approximately 65 days.

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

101652, MUSC CTO# 101652 Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme Response to Treatment with Bevacizumab for Progressive Disease + save

Date Added
October 15th, 2013
PRO Number
Pro00014338
Researcher
Scott Lindhorst
Keywords
Cancer, Cancer/Brain
Summary

Subjects are being asked to volunteer because they are on or about to start a medication called bevacizumab (BEV) as a treatment for their diagnosis of a brain tumor called glioblastoma. BEV is a drug that the study doctor believes is the best treatment option available to subjects at this time.

BEV affects the growth of blood vessels by tumors such as glioblastoma, thus effectively starving the tumor of oxygen and food.

Magnetic Resonance Imaging (MRI) is a test done by a machine in the radiology department that takes pictures of your body using special magnets, rather than X-rays.

With a new MRI scan technique the study doctor can take very, very detailed images of the vessel and tumor structure. This project will allow him to compare the images of vessel and tumor structure to the effectiveness of BEV as a treatment option. With this project the study team will hopefully develop an accurate way to predict whether or not BEV will be an effective treatment option for patients.

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

ANHL1131: INTERGROUP TRIAL FOR CHILDREN OR ADOLESCENTS WITH B-CELL NHL OR B-AL: EVALUATION OF RITUXIMAB EFFICACY AND SAFETY IN HIGH RISK PATIENTS + save

Date Added
October 10th, 2013
PRO Number
Pro00021704
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

A large randomized trial is necessary to evaluate whether rituximab can add benefit to the current chemotherapy regimen. Two pilot studies in children provide preliminary evidence of safety and activity of rituximab in this disease setting that support such a study. A Berlin-Frankfurt-Münster group (BFM) study, which tested a single dose of rituximab administered prior to chemotherapy, has shown tumor responses. A COG pilot study tested the safety and tolerability of the combination of rituximab with LMB chemotherapy and showed no increased short term toxicity.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843.792.2957
kravekjm@musc.edu

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

Date Added
October 8th, 2013
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

Using Serum HE4 and CA125 to Monitor the Therapeutic Effects in Ovarian Cancer Patients Based on Histological Subtypes + save

Date Added
October 8th, 2013
PRO Number
Pro00019893
Researcher
Yusheng Zhu
Keywords
Cancer, Cancer/Gynecological
Summary

This study is for female adult subjects with ovarian cancer. CA125 is a protein (compound made by the body) found in blood that is used to monitor treatments and disease progression in ovarian cancer patients. HE4 is also a protein that is used in the evaluation of ovarian cancer and disease monitoring. Both CA125 and HE4 are approved by the FDA to monitor the treatment of ovarian cancers. The purpose of this study is to investigate HE4 and CA125 expressions in different types of ovarian cancer and to evaluate the changes in HE4 and CA125 before and after treatment. A blood draw of approximately 5mL or 1 teaspoon will be taken from eligible subjects before surgery and before each course of chemotherapy to evaluate HE4 and CA125 expression.

Institution
MUSC
Recruitment Contact
Karie Olsen
843-792-3966
olsenk@musc.edu

A Phase I/II Study of the ALK Inhibitor CH5424802/ RO5424802 in Patients with ALK-Rearranged Non-Small Cell Lung Cancer Previously Treated with Crizotinib + save

Date Added
October 8th, 2013
PRO Number
Pro00027208
Researcher
Keisuke Shirai
Keywords
Cancer, Cancer/Lung, Lung
Summary

The purpose of this research is to review the effectiveness of RO5424802 in subjects diagnosed with Non-Small Cell Lung Cancer (NSCLC) that has spread to areas near the lungs or to at least one other location in the subject's body and his/her cancer has recurred or gotten worse after being treated with chemotherapy and Crizotinib.

Institution
MUSC
Recruitment Contact
Jessica Salamacha
843-792-6429
salamach@musc.edu

A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer + save

Date Added
October 3rd, 2013
PRO Number
Pro00017993
Researcher
Frank Brescia
Keywords
Cancer, Cancer/Breast, Drug Studies, Women's Health
Summary

This study is being done for the following reasons:
•This study is being done to find out if a combination of just two chemotherapy drugs, docetaxel and cyclophosphamide, is as good as using different combinations of the chemotherapy drugs doxorubicin and cyclophosphamide, given with either docetaxel or paclitaxel, in treating your type of breast cancer. All of these drugs are used in standard combinations of chemotherapy for breast cancer.
•The researchers also want to learn about the side effects of the combinations of drugs used in this study. Side effect information will also be studied to see if there are any differences between the two-drug and three-drug chemotherapy combinations.
•In order to learn more about cancer tumors, this study includes special research tests that will be done on tumor tissue that was removed during your breast cancer surgery. Information about this study requirement will be explained to you in more detail later in this consent form.

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