Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (R05185426) Adjuvant Therapy in Patients with Surgically-Resected Cutaneous BRAF Mutant Melanoma at High Risk for Recurrence Save

Date Added
December 9th, 2013
PRO Number
Pro00021186
Researcher
Keisuke Shirai
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to find out whether vemurafenib can help prevent or delay the return of melanoma that is at a high risk of returning (Stage IIC, IIIA, IIIB or IIIC) after it has been removed surgically. The study will also assess whether the drug causes side effects in patients.
Vemurafenib was recently approved in the United States for the treatment of patients with metastatic melanoma. Vemurafenib remains an investigational drug being studied by Roche.

Institution
MUSC
Recruitment Contact
Robin Bostick
843-792-8876
bostickr@musc.edu

Randomized Phase II Trial Of PET Scan-Directed Combined Modality Therapy In Esophageal Cancer Save

Date Added
December 3rd, 2013
PRO Number
Pro00016547
Researcher
Charles Bowers
Keywords
Cancer, Cancer/Gastrointestinal, Throat
Summary

The purpose of this trial is to learn if the outcomes for patients with esophageal cancer can be improved by using PET/CT scans to determine whether or not a particular chemotherapy regimen is showing any effect on the tumor. Researchers are trying to learn if PET/CT response can be used as a way to better direct therapy.

PET scans show the activity of cells and can help doctors to measure how active tumor cells are. Previous studies among patients with esophageal cancer have shown that comparing PET/CT scans prior to starting chemotherapy and after receiving several weeks of therapy can predict those who are poor responders to chemotherapy and those who have a better response to chemotherapy. This study is using two different chemotherapy regimens, which are FDA approved for this type of esophageal cancer, as induction chemotherapy, meaning the chemotherapy is given first, prior to radiation therapy and surgery. The two chemotherapy regimens have both been studied in esophageal cancer and have been found to have similar effects on tumors. The two chemotherapy regimens are FOLFOX6 and carboplatin/paclitaxel.

This is a phase II randomized trial. Phase II trials are studies that evaluate the efficacy of a treatment approach. This study also includes a “randomization” which means that subjects will randomly be assigned to one or the other treatment group and have a 50% chance of receiving FOLFOX6 and a 50% chance of receiving carboplatin/paclitaxel.

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

An Open-Label, Phase 1/Phase 2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of the DNA Minor Groove Binding Agent SG2000 in the Treatment of Advanced CLL and AML, Save

Date Added
November 26th, 2013
PRO Number
Pro00019231
Researcher
Robert Stuart
Keywords
Cancer, Men's Health, Women's Health
Summary

The primary objective is to determine the MTD and safety profile of SG2000 in adult subjects with AML and CLL.
The secondary objectives are as follows to characterize the PK profile of SG2000 in subjects with CLL and AML; to describe the preliminary efficacy profile of SG2000 in subjects with CLL and AML and to investigate the following clinical and laboratory parameters as potential predictors of VLS: orthostatic blood pressure, albumin levels, weight changes, edema, and pulmonary findings.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
Salzers@musc.edu

Preferences of Average Risk Colorectal Cancer Screening Save

Date Added
November 19th, 2013
PRO Number
Pro00030033
Researcher
Cathy Melvin
Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Other, Colonoscopy, Digestive System
Summary

Ths study will help us to understand which CRC test patients prefer, and whether patients using a home based stool test will complete and return the test as reccomended.

Institution
MUSC
Recruitment Contact
Cathy Melvin
843-876-2426
melvinc@musc.edu

A Phase II Multi-Center Study of Bevacizumab in Combination with Ixabepilone in Subjects with Advanced Renal Cell Carcinoma. Save

Date Added
November 19th, 2013
PRO Number
Pro00027639
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients with advanced renal cell carcinoma. This is a Phase II study for the experimental treatment of kidney cancer. The drugs to be examined in this study are a combination of ixabepilone and bevacizumab. The purpose of this phase II study is to determine whether the combination of ixabepilone administered for five consecutive days and bevacizumab administered on one day, both repeated every three weeks, is effective in the treatment of kidney cancer.

Institution
MUSC
Recruitment Contact
Seth Price
843-792-6969
pricesr@musc.edu

Randomized Phase II Trial of Individualized Adaptive Radiotherapy Using During-Treatment FDG-PET/CT and Modern Technology in Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Save

Date Added
November 19th, 2013
PRO Number
Pro00026773
Researcher
James Ravenel
Keywords
Cancer, Cancer/Lung, Lung, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with lung cancer who cannot have surgery because of the location of or advanced stage of the cancer or other serious health problems such as emphysema, diabetes, or heart disease. The purpose of this study is to find out if more intense (higher dose) radiation treatment based on the FDG-PET/CT imaging improves treatment of this cancer with the same possible damage to healthy lung tissue compared to treatment with standard radiation therapy. The higher dose radiation is aimed at the tumor. Patients will be randomized into one of two groups; Group A will receive standard radiation treatment once daily, 5 days a week for 5 weeks. They will also will receive chemotherapy (paclitaxel and carboplatin), once a week for 6 weeks. Group B will receive radiation treatment once daily, 5 days a week for 3-4 weeks. This radiation treatment will be a higher dose per day than standard radiation. Patients will also receive chemotherapy (paclitaxel and carboplatin), once a week for 6 weeks. Both groups will receive Paclitaxel and carboplatin are given by vein before radiation therapy. Both groups will also receive paclitaxel and carboplatin by vein every 21 days X 3, a total of 3 cycles of chemotherapy four to six weeks after radiation treatment is completed.

Institution
MUSC
Recruitment Contact
Scott Landreth
843-792-6429
landrets@musc.edu

Rationale for Late-Stage Diagnosis in Oral and/or Oropharyngeal Cancer for Patients Living in the United States Save

Date Added
November 18th, 2013
PRO Number
Pro00008251
Researcher
Betsy Davis
Keywords
Cancer, Cancer/Head & Neck
Summary

The main specific aim is to determine if late stage as opposed to early stage diagnosis of oral cancer are related to the following patient related factors: psychological, socioeconomic, risky/healthy behaviors, symptom interpretation and access to healthcare. An additional specific aim is to compare risky/healthy behaviors, sign / symptom interpretation and stages of delay between the early and late stages group..

Institution
MUSC
Recruitment Contact
Adam Fiebelkorn
843-792-6349
fiebelko@musc.edu

A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0010718C in subjects with metastatic or locally advanced solid tumors and expansion to selected indications. Save

Date Added
November 12th, 2013
PRO Number
Pro00030051
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

The main purpose of this research trial is to test the investigational drug MSB0010718C at different dose levels to see if it is safe and well tolerated when given once every two weeks. Based on this information the sponsor of this study hopes to learn which dose (drug strength) could be best for treatment of subjects.
Additional purposes of the trial are to assess side effects of MSB0010718C and to find out whether MSB0010718C has anti-cancer effects. In addition, the sponsor would like to find out how MSB0010718C is processed by the body (this is called pharmacokinetic or PK research).
Approximately 380 people will participate in the expansion part of the trial. The research trial will be conducted in up to 130 medical centers in the US and Europe. About 10 of those patients will be enrolled at MUSC under the care of Carolyn Britten, MD.

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

Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy at Pre-Treatment, Post-Treatment, and at Six Month Follow-Up Save

Date Added
November 5th, 2013
PRO Number
Pro00010437
Researcher
Sharmila Mehta
Keywords
Cancer, Cancer/Breast, Cancer/Lymphoma, Memory Loss, Mental Health, Non-interventional
Summary

This study is being conducted to better understand how common cognitive difficulties are by using cognitive testing measures, as well as self-report measures. It is believed that cognitive difficulties associated with cancer and chemotherapy treatments may be related to increased inflammation and other processes that can impact inflammation in the body; inflammation and inflammation-related processes are associated with cognitive difficulties in other diseases, and the same may be true for cancer and cognition. Inflammation is the basic way in which the body reacts to infection, irritation or other injury. This study will evaluate these relationships in this study by assess subject's blood and DNA.

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