RANDOMIZED PHASE II TRIAL OF CONCURRENT BEVACIZUMAB AND RE-IRRADIATION VERSUS BEVACIZUMAB ALONE AS TREATMENT FOR RECURRENT GLIOBLASTOMA Save

Date Added
March 19th, 2013
PRO Number
Pro00023155
Researcher
Scott Lindhorst
Keywords
Cancer, Cancer/Brain, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have a brain tumor, called a glioblastoma or gliosarcoma, which has become worse after previous treatment. The purpose of this study is to determine whether adding radiation to bevacizumab is more effective than using bevacizumab alone to treat recurrent glioblastomas.
In this trial patients will be randomly assigned to receive either bevacizumab alone or bevacizumab and radiation therapy.If you are in Group 1, you will be asked to take bevacizumab alone every two weeks as long as it is working and there are no intolerable side effects. If patients are assigned to Group 2, he/she will take bevacizumab 2 weeks before radiation therapy, during radiation therapy, and then every 2 weeks after radiation therapy as long as it is working and there are no intolerable side effects. The radiation will be given to participants over 2 weeks. Participants will be followed every 8 weeks while on treatment and then also if participants are removed from protocol treatment. Follow-up will continue every 8 weeks for 1 year, then every 6 months for 1 year, then annually.

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

A Phase II Preventative Trial of DFMO (eflornithine HCl) as a Single Agent in Patients with High Risk Neuroblastoma in Remission Save

Date Added
March 5th, 2013
PRO Number
Pro00023495
Researcher
Jacqueline Kraveka
Keywords
Cancer, Pediatrics
Summary

Approximately half of all children with high risk neuroblastoma who have achieved remission will relapse, and once relapse has occurred, there is no curative therapy for these children. High risk neuroblastoma does not respond well to standard chemotherapy, and there are few options currently available to prevent relapse for children in remission. DFMO is a drug that has been shown to be effective in adults with cancers that have characteristics similar to neuroblastoma. It has not been extensively studied in children. This study will look at the ability of DFMO to keep neuroblastoma in remission, and to study the safety and tolerability of the drug when used in children.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@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
February 12th, 2013
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 III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of EVEROLIMUS in Patients with High-Risk, Hormone Receptor-Positive AND HER2/neu Negative Breast Cancer Save

Date Added
January 16th, 2013
PRO Number
Pro00022260
Researcher
Sara Giordano
Keywords
Cancer, Cancer/Breast
Summary

This study is for women or men with hormone responsive breast cancer that has already been removed by surgery and have completed any required chemotherapy or radiation. The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for breast cancer patients. In this study subjects will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.
It is expected that subjects will be enrolled in this study for approximately 54 weeks or until side effects become too great, or until cancer returns. After subjects are finished with study treatment, they will return to the clinic every six months for the first 2 years and then yearly for the next 10 years.

Institution
MUSC
Recruitment Contact
Marietta Gustilo
843-792-2584
gustilom@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
January 7th, 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 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

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