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

Date Added
July 28th, 2015
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, before each course of chemotherapy and at the time of disease response assessment to evaluate HE4 and CA125 expression.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Physician Order for Scope of Treatment (POST): PILOT STUDY Save

Date Added
July 22nd, 2015
PRO Number
Pro00022252
Researcher
Walter Limehouse
Keywords
Aging, Alzheimers, Cancer, Dementia, Ethnicity and Disease, Geriatrics, Heart, HIV / AIDS, Infectious Diseases, Kidney, Liver, Men's Health, Minorities, Nervous System, Pulmonary, Rare Diseases, Women's Health
Summary

South Carolina Coalition for Care of Serious Illness (SCC CSI) sponsors development of Physician Orders for Scope of Treatment (POST) in South Carolina. The SC POST follows the national POLST (www. polst.org) paradigm creating an advance treatment planning physician order that migrates as valid across institutional boundaries: from physician office, to home/nursing home/hospice to EMS to hospital emergency/inpatient services. The POST form encourages a conversation between a physician and the patient regarding treatment options available to seriously ill patients for whom death within a year would not be a surprise. These choices primarily include whether to attempt cardiopulmonary resuscitation in the event of cardiac or pulmonary arrest or not (a ?DNR? or ?Allow Natural Death? order) and whether during acute illness to provide full treatment including endotracheal intubation and intensive care, supportive treatment such as noninvasive ventilation and no intensive care, or comfort care only. The Charleston and Greenville areas will pilot POST. Investigators by area will survey providers completing POST documents for patients or treating patients with POST about the utility of this form and how use of the form affected their patient's treatment. A chart reviews of patients presenting with a POST form to a hospital emergency or inpatient unit will address whether providers respected patient treatment choices. SCC CSI plans to publish the results of the pilot in appropriate journals and present the results at medical meetings and to interested persons. The results of the study may provide the supporting documentation for subsequent legislation supporting POST. POST represents a coordinated statement of a seriously ill patient?s treatment choices to be honored across multiple treatment settings.

Institution
MUSC
Recruitment Contact
Walter Limehouse
792-9705
limehouw@musc.edu

A Traditional Feasibility study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma Save

Date Added
July 21st, 2015
PRO Number
Pro00043494
Researcher
Samuel Cooper
Keywords
Cancer, Cancer/Gastrointestinal
Summary

This study is for adult patients with intrahepatocellular carcinoma. The purpose of this research study is to evaluate the safety and maximum tolerated dose of Gemcitabine and Cisplatin with 90Y TARE. Subjects will have screening tests to determine if he or she is eligible to participate in this study. If the subject is eligible and wishes to enroll, he or she will begin chemotherapy treatment with Gemcitabine and Cisplatin. During the chemotherapy treatment, the patient will receive the 90Y TARE treatment. Study treatment will last up to 8 cycles; each cycle is 21 days. Subjects will be followed after treatment is completed for up to 6 years after treatment started.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Multicenter, Open-label, Single-arm, Study of Enzalutamide Re-Treatment in Metastatic Castration-Resistant Prostate Cancer, As First Treatment Post-Decetaxel in Patients Who Have Previously Received Enzalutamide in the Pre-Chemotherapy Setting Save

Date Added
July 14th, 2015
PRO Number
Pro00044714
Researcher
Michael Lilly
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for patients that have been diagnosed with metastatic castration-resistant prostate cancer and have been previously treated with enzalutamide followed by docetaxel. This experimental study is being done to study the effectiveness and safety of enzalutamide when it is administered as re-treatment, following prior enzalutamide use and treatment with docetaxel. The length of time that patients are in the study will depend on their tolerance of the study medication and the state of their disease. They will continue in the study until they show signs of disease progression or unacceptable toxicity of the study medication.

Institution
MUSC
Recruitment Contact
Mike Wheeler
843-792-2306
wheelerm@musc.edu

Head and Neck Cancer Symptom and Lifestyle Index Save

Date Added
July 7th, 2015
PRO Number
Pro00031994
Researcher
Valerie Fritsch
Keywords
Cancer
Summary

This study is designed to prospectively evaluate HNSCC?s presenting symptoms in detail. More specifically, our study aims to (1.) characterize the earliest presenting symptom(s) of head and neck cancer, and (2.) identify and describe a symptom set that can distinguish ?high risk? patients who should be considered to have head and neck cancer until proven otherwise.

All newly diagnosed patients with HNSCC who are evaluated at Hollings Cancer Center will be offered the opportunity to complete a detailed, comprehensive survey within 2 weeks of their initial consultation appointment. The survey responses will be quantitatively and qualitatively analyzed to identify common symptom characteristics and patterns. The results will eventually be correlated with final pathologic staging and features, treatment response, and outcome.

Institution
MUSC
Recruitment Contact
Valerie Fritsch
843-792-8363
vaf3@musc.edu

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

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High-Risk Prostate Cancer: A Phase III Randomized Trial Save

Date Added
November 7th, 2013
PRO Number
Pro00028856
Researcher
David Marshall
Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area to determine which is better.

There are 2 treatment groups in this study:
1) Patients who receive hormone therapy plus radiation therapy to the prostate gland and seminal vesicles
2) Patients who receive hormone therapy plus radiation therapy to the whole pelvis

Institution
MUSC
Recruitment Contact
Kelly Hawthorne
864-725-4111
khawthorne@selfregional.org

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-M

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843.792.2957
kravekjm@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

ASCT1221: A Randomized Phase II Study Comparing Two Different Conditioning Regimens Prior to Allogeneic Hematopoietic Cell Transplantation (HCT) for Children with Juvenile Myelomonocytic Leukemia (JMML) Save

Date Added
September 20th, 2013
PRO Number
Pro00027972
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

Although JMML is an uncommon disease, it occurs exclusively in very young
children (median age ~ 2.5 years) indicating an increased risk for TRM and late
effects associated with maximum intensity conditioning regimens. Moreover, there is currently no agreed upon standard of care preparative regimen in use for
patients with JMML. Previous studies suggest that there are significant toxicities
associated with conditioning regimens currently in use today. Moreover, the
relapse rates were fairly high and it appears that further escalation of the
conditioning regimens is unlikely to produce significant improvements in EFS or
relapse rates without unacceptable TRM. Therefore, it is essential that novel
strategies be developed to reduce the high rates of relapse that have been
observed.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu

Change_preferences

-- OR --

Create_login