A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or CT 2103 (IND# 70177) Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancer who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy Save

Date Added
November 16th, 2012
PRO Number
Pro00020221
Researcher
William Creasman
Keywords
Cancer, Women's Health
Summary

This study is for patients with ovarian, primary peritoneal or fallopian tube cancer that has been confirmed by surgery. Primary peritoneal and fallopian tube cancers are considered identical to ovarian cancers in terms of microscopic appearance and treatment; they differ only by the initial body site of cancer development. In this research study, women with advanced ovarian, primary peritoneal or fallopian tube cancer who have no evidence of disease after the completion of initial chemotherapy will be randomly assigned (like the flipping of a coin) to one of the three possible treatment regimens to determine which will result in longer patient survival rates if continued once a month for 12 months versus stopping all chemotherapy until there is evidence of recurrence of the disease process. Patients have an equal chance of being placed in any one of the three regimens. Neither the patient nor the study doctor will decide which regimen will be received. Two different chemotherapy regimens and one regimen including no further treatment will be examined and compared. The first of the chemotherapy arms, paclitaxel, is a standard chemotherapy drug used to treat ovarian cancer. The second agent, CT-2103, is an experimental drug with anti-cancer activity similar to that of paclitaxel.

Patients will undergo a thorough check-up prior to the start of treatment. Additionally, they will be asked to complete a questionnaire about their quality of life a total of six times: once before going on the study, 2, 4, 6 and 12 months later, and then one year after completing treatment.

If patients are randomized to receive either paclitaxel or CT-2103, they will be given the drug, once a month through their vein, for a maximum of 12 monthly cycles. The paclitaxel is delivered over 3 hours, while CT-2103 is given as a 10-20 minute infusion.

This study is also interested in testing samples of patients? blood and tumors to determine if this testing can be used in the future to determine which patients may respond to treatment, have side effects or have a good prognosis.

Patients randomized to receive either paclitaxel or CT-2103 will recieve treatment for a maximum of 12 months depending on how well they respond and the seriousness of any side effects. The study doctor will follow patients' medical condition by office visits every three months for two years and then every six months for three more years.

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

EXOSOME-DERIVED BIOMARKERS FOR THE DIAGNOSIS AND MANAGEMENT OF PROSTATE CANCER (PCa) Save

Date Added
November 14th, 2012
PRO Number
Pro00019697
Researcher
Michael Lilly
Keywords
Cancer, Cancer/Genitourinary, Healthy Volunteer Studies
Summary

This study is for subjects with prostate cancer. The purpose of this study is to evaluate plasma (the liquid portion of blood) and urine samples from subjects diagnosed with prostate cancer, from subjects who are at high risk for prostate cancer but have not been diagnosed with the disease or subjects without a history of prostate cancer. These samples will be used to develop methods for isolating exosomes for evaluation and monitoring of prostate cancer. Approximately 10 mL (or 2 teaspoons) of blood and 30 mL (or 2 tablespoons) of urine will be taken from subjects no more frequently than twice per week up to six times over three years . These samples will be obtained during routine clinic visits. Healthy subjects will have only one blood draw at baseline and the collection will be obtained in a private location. Subjects may continue you on this study for 3 years. Clinic visits may take from 1 to 3 hours depending on clinic schedules.

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

Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GnRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GnRH Agonist and TAK-700 for Men with High Risk Prostate Cancer Save

Date Added
October 2nd, 2012
PRO Number
Pro00018969
Researcher
David Marshall
Keywords
Cancer, Prostate
Summary

The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and TAK-700 plus radiation therapy with hormone therapy (androgen deprivation) and radiation therapy on patients with prostate cancer.
There are 2 treatment groups in this study. Group 1will receive hormone therapy plus radiation therapy only and Group 2 will receive hormone therapy and TAK-700 plus radiation therapy.
Subjects will receive hormone therapy for 24 months. Radiation will be given in 44 treatments over approximately 2 months. If the subject is in Group 2 they will take TAK-700 for 24 months. After the subject is finished receiving therapy, the study doctor will ask the subject to visit the office for follow-up exams every 6 months for 3 years and then once a year.

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

Vitamin D3 Supplementation for Low-Risk Prostate Cancer, A Randomized Trial Save

Date Added
September 18th, 2012
PRO Number
Pro00019745
Researcher
Sebastiano Gattoni-celli
Keywords
Cancer, Prostate, Vitamin D
Summary

This randomized clinical trial will enroll 136 men recently diagnosed with Early-Stage prostate cancer. Men must be 19 or older with a prostate biopsy Gleason score ? 6 and PSA ?10 who have decided that active surveillance is their present treatment option. Study visits will be every 4 months for just over a year in Charleston, S.C. There will be two groups, one taking vitamin D3 supplement and the other taking a placebo. Assigment to each group will be by chance and neither the particpant nor the study team will know to which group they are assigned. Blood and urine samples will be collected at each visit for research purposes. A survey relating to the subjects' decision making about their biopsies will be completed at the baseline and final visits. Waist/hip ratio and blood pressure measurements will also be obtained at the baseline and final study visits. Each participant will be in the study until a repeat prostate biopsy is performed by their own Urologist as Standard of Care for Active Surveillance regimen.

Institution
MUSC
Recruitment Contact
Linda Ambrose
843-792-8303
ambrosel@musc.edu

PH IRB #2012-061; Pro00017643: Lung Cancer Surgery: Decisions Against Life Saving Care ? The Intervention. Save

Date Added
August 16th, 2012
PRO Number
Pro00017643
Researcher
Rohan Arya
Keywords
Cancer, Cancer/Lung, Ethnicity and Disease, Men's Health, Minorities, Pulmonary, Stage I, Stage II, Surgery, Women's Health
Summary

Lung cancer is the leading cause of cancer death with a higher mortality rate among African Americans. For patients that have stage I or II non-small cell cancer, surgery is the only curative treatment. In a previous study we conducted, we found that African Americans were less likely to have surgery than other groups. The purpose of this study is to find out what patients understand about their medical condition, what can be done to get the very best lung cancer surgery treatment, and how we can close the treatment gap.

Institution
Palmetto
Recruitment Contact
Alisha Henderson
803-799-5022
alisha.henderson@uscmed.sc.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
August 7th, 2012
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

Pilot Study of Serpin Biomarkers in Response to Radiotherapy Save

Date Added
July 20th, 2012
PRO Number
Pro00016884
Researcher
Kenneth Tew
Keywords
Cancer, Men's Health
Summary

Radiotherapy is a known treatment for many types of malignancies, but it is also a toxic treatment with variable side effects. Our goal is to develop biomarkers that predict radiotherapy efficacy and toxicity for various individual patients and malignancies. Biomarkers that verify radiosensitivity of particular tumors or response of normal tissues to radiotherapy would alleviate ineffective treatment strategies and unnecessary side effects. Preliminary data suggest that some plasma protiens are post translationally modified when animals are exposed to NOV-002 (drug that causes reactive oxygen species, similar to those reactive oxygen species caused by radiotherapy). Using a small amount of human blood, we intend to use immunoblot and proteomic analysis to identify possible biomarkers of response to radiotherapy. Two early leads have been protease inhibitors known as serpins (serine protease inhibitor and alpha-1-antitrypsin 1-6 precursor or Serpins a1 and a3). The activity of serpins may be attenuated by S-glutathionylation which may warant genotype analysis for glutathion-S-transferase-P. Furthermore, serpin S-glutathionylation induced by redox chemotherapeutics may have roles in the reversal of chemotherapy induced hematological suppression.

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

A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients Save

Date Added
July 3rd, 2012
PRO Number
Pro00017387
Researcher
Jennifer Jaroscak
Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

This study if for patients that have a blood disease and it's been determined that the best option for treating that blood disease is a cord blood transplant. Cord blood (CB) is blood that is taken from the umbilical cord and placenta of healthy newborn babies after childbirth. The cord blood collected from a newborn baby is called a cord blood unit. The United States Food and Drug Administration (FDA) considers cord blood to be a biological drug. These are considered ?investigational? products. This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems.

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

AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum Save

Date Added
June 22nd, 2012
PRO Number
Pro00016822
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

To collect information about the patient's leukemia and to seek the optimal treatment for children with ALL based on the individual level of risk of the cancer coming back after treatment. The risk groups are defined as a result of recent research conducted by the Children?s Oncology Group (COG). We would like to learn if the use of an experimental intrathecal therapy (ITT), which has been given to many people with ALL and has been well tolerated, would be better at preventing relapse in the central nervous system and improve disease outcomes in children with High Risk ALL.

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

A Randomized, Open-label, Phase II, Multi-center Trial of Gemcitabine (G) with Pazopanib (P) or Gemcitabine (G) with Docetaxel (T) in Previously Treated Subjects with Advanced Soft Tissue Sarcoma. Save

Date Added
March 13th, 2012
PRO Number
Pro00015882
Researcher
Daniel Reuben
Keywords
Cancer, Cancer/Sarcoma
Summary

The purpose of this study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with Gemcitabine and Docetaxel in participants with soft tissue sarcoma. Screening tests will be done to ensure subjects are eligible to participate in this study. If the exams, tests and procedures show that subjects can be in the study, and they choose to take part, then they will be ?randomized? into one of the two study groups: Group 1 or Group 2. Subjects in Group 1 will receive Gemcitabine 1000 mg/m2 intravenously (directly into a vein) on Day 1 and Day 8 and Pazopanib 800mg by mouth daily. Subjects in Group 2 will receive Gemcitabine 900 mg/m2 intravenouslyon Day 1 and Day 8 and Docetaxel 100 mg/m2 intravenously on Day 8. Both groups will be in 21 day cycles. Both groups will be asked to complete 2 ?quality of life? questionnaires, on their first visit, then at 6 weeks (2nd cycle), 18 weeks (6th cycle) and at the end of study treatment. Subjects will be followed for up to 2 years.

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

Change_preferences

-- OR --

Create_login