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

Date Added
August 26th, 2014
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

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

Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis Save

Date Added
August 5th, 2014
PRO Number
Pro00036914
Researcher
Patricia Griffin
Keywords
Bone, Cancer, Cancer/Brain, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Leukemia, Cancer/Lung, Cancer/Lymphoma, Cancer/Myeloma, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Spinal Cord
Summary

Multiple radiation treatments are frequently used to treat pain caused by cancer that has spread to the spine. Image-guided radiosurgery/stereotactic body radiation therapy (SBRT) is a treatment that uses highly focused x-rays to deliver a single high dose on a specific area of the body. Image-guided radiosurgery/SBRT uses special equipment to position the patient and guide the focused beams toward the area to be treated and away from normal tissue.

The purpose of this part of the study is to compare the effects, good and/or bad, of image-guided radiosurgery/SBRT to standard radiation therapy to find out which treatment provides the most rapid pain relief with the least side effects.

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

Limited Access Phase I/II Trial Of Paclitaxel, Cisplatin And CTEP Supplied Agent ABT-888 (Veliparib) (IND#77840, NSC#737664) In The Treatment Of Advanced, Persistent, Or Recurrent Carcinoma Of The Cervix Save

Date Added
May 28th, 2014
PRO Number
Pro00026211
Researcher
Jennifer Young
Keywords
Cancer, Cancer/Gynecological
Summary

This study is for patients that have cervical cancer that has not responded
to prior treatment or has re-grown after prior treatment. The purpose of the first part of this study (called Phase I) is to test the safety and determine the
appropriate dose of ABT-888, given in a capsule form and also known as Velaparib, in combination with receiving cisplatin and paclitaxel intravenously (though a vein). The purpose of the second part of this study is to determine the effectiveness of ABT-888 in combination with intravenous (through the
vein, IV) cisplatin and paclitaxel. We will also be looking at the types and severity of side effects caused by treatment with this drug. ABT-888 inhibits the enzyme Poly ADP ribose polymyerase (PARP), which inhibits DNA repair and may lead to decrease in cancer cell activity. Currently ABT-888 is not FDA approved for treatment of your cancer and is considered experimental.
Participants will be asked to receive IV paclitaxel, IV cisplatin and take ABT-888 as long as there is evidence that the tumor is not growing and the participant is not experiencing any unacceptable side effects.
After participants are finished with this treatment, the study doctor will ask them to visit the office for follow-up exams every three months for the first two years and then every six months for the next three years after completion of their treatment with paclitaxel, cisplatin and ABT-888.

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

A Randomized Phase II Study With A Phase I Lead-In To Assess The Antitumor Efficacy Of The MEK Inhibitor Trametinib Alone Or In Combination With GSK2141795, An AKT Inhibitor In Patients With Recurrent Or Persistent Endometrial Cancer. Save

Date Added
May 20th, 2014
PRO Number
Pro00034359
Researcher
Carolyn Britten
Keywords
Cancer/Gynecological, Women's Health
Summary

The purpose of this study is to determine the effectiveness of Trametinib alone or in combination with GSK2141795 in treating recurrent or persistent endometrial cancer and to determine the types and severity of side effects caused by treatment with these drugs.
Trametinib and GSK2141795 are both experimental drugs. Experimental means that the drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA) or similar regulatory agencies in foreign countries. These drugs are being evaluated in endometrial cancer because they act in ways which are thought to be important in the growth and survival of endometrial cancer.

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

A pilot study evaluating vitamin D deficiency and risk of aggressive uterine cancer in African American as compared to White women Save

Date Added
May 19th, 2014
PRO Number
Pro00030938
Researcher
Whitney Graybill
Keywords
Cancer/Gynecological, Women's Health
Summary

The purpose of this study is to evaluate vitamin D levels in African American and White women who present with a new diagnosis of uterine cancer.

Institution
MUSC
Recruitment Contact
Tamara Saunders
843-792-6992
saundert@musc.edu

A Phase II Trial of DCTD-Sponsored Dasatinib (NSC #732517 IND #120636) In Recurrent/Persistent Ovary, Fallopian Tube, Primary Peritoneal, and Endometrial Clear Cell Carcinoma Characterized for the Retention or Loss of BAF250a Expression Save

Date Added
May 6th, 2014
PRO Number
Pro00033486
Researcher
David Griffin
Keywords
Cancer, Cancer/Gynecological, Drug Studies
Summary

This phase II trial studies how well dasatinib works in treating patients with persistent ovarian, fallopian tube, endometrial, or peritoneal cancer. Dasatinib may shrink patients' tumors by blocking some of the enzymes needed for cell growth.

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

Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials Save

Date Added
May 6th, 2014
PRO Number
Pro00034158
Researcher
Sharmila Mehta
Keywords
Cancer, Cancer/Brain, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Leukemia, Cancer/Lung, Cancer/Lymphoma, Cancer/Myeloma, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Education, Non-interventional
Summary

The purpose of this study is to find out if providing patients with educational materials helps them to be better prepared for making a decision about participating in a research study to treat their cancer.

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

A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer Save

Date Added
April 30th, 2014
PRO Number
Pro00034096
Researcher
Whitney Graybill
Keywords
Cancer/Gynecological, Women's Health
Summary

This study is for adult women who have advanced or recurrent endometrial (uterine) cancer. The purpose is to find out if the drug combination of paclitaxel, carboplatin and metformin works better than paclitaxel and carboplatin alone in treating uterine cancer.

Institution
MUSC
Recruitment Contact
Sarah Booker
843-792-9190
bookers@musc.edu

A Phase II Trial Evaluating Cisplatin (NSC#119875) and Gemcitabine (NSC #613327) Concurrent with Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva Save

Date Added
March 13th, 2014
PRO Number
Pro00025562
Researcher
David Griffin
Keywords
Cancer, Cancer/Gynecological, Drug Studies
Summary

The purpose of this study is to find out if radiation therapy along with the addition of the drugs, cisplatin and gemcitabine, works in treating locally advanced squamous cell carcinoma of the vulva and to find out what side effects or surgical complications are caused by treatment with this combination.

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