A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma Save

Date Added
September 19th, 2013
PRO Number
Pro00029068
Researcher
James Bearden
Keywords
Cancer, Cancer/Brain, Drug Studies
Summary

The purpose of this study is to:
? See if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in patients who have been diagnosed with cancer and are experiencing fatigue.
? See the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue.

In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent). They will not take both.

Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders. However, it is not been studied in people with cancer related fatigue.

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

A Phase 1B Open-Label Three-Arm Multi-Center Study to Assess the Safety and Tolerability of PF-05212384 (PI3K/mTOR Inhibitor) in Combination with Other Anti-Tumor Agents Save

Date Added
August 27th, 2013
PRO Number
Pro00027912
Researcher
Carolyn Britten
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is enrolling male and female patients with a diagnosis of advanced solid tumor. The purpose of this research study is to learn about the effects of and to find the best dose of the study drug, PF 05212384, when given in combination with other drugs. This study will determine the highest dose of PF-05212384 that can be tolerated when given in combination with other drugs; this PF-05212384 dose is called the maximum tolerated dose or MTD. Enrolled patients can expect to be in this study for about 6 months. They will need to visit the research site at least 12 times during the study. Patients may stay in the study until the disease gets worse or they decide to stop participating.

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

A Phase III Prospective Randomized Trial Of Dose-Escalated Radiotherapy With Or Without Short-Term Androgen Deprivation Therapy For Patients With Intermediate-Risk Prostate Cancer Save

Date Added
August 19th, 2013
PRO Number
Pro00027510
Researcher
David Marshall
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for patients with prostate cancer. The purpose of this study is to compare the effects of dose-escalated radiation therapy with or without hormone therapy on your prostate cancer.
There are 2 treatment groups in this study:
1) Patients who receive radiation therapy only
2) Patients who receive radiation therapy plus hormone therapy
Patients will receive 44 radiation treatments over approximately 2 months. If the patient chooses to receive the brachytherapy implant, he will receive 25 daily treatments plus the implant procedure over a timeframe of approximately 6 weeks. Hormone therapy, if given, will last 6 months. After patients are finished receiving therapy, the study doctor will ask them to visit the office for follow-up exams at 3, 6, 9, and 12 months after finishing radiation treatment, every 6 months for 4 years, and yearly thereafter.

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

Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab + Bendamustine Followed By Rituximab Consolidation (RB? R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV? R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB ? LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV ? LR) Save

Date Added
June 20th, 2013
PRO Number
Pro00026391
Researcher
Asim Pati
Keywords
Cancer, Cancer/Lymphoma, Drug Studies
Summary

The purpose of this study is two-fold and has two steps of treatment:
1) In step 1, to find out what effects, good and bad, the addition of bortezomib to rituximab plus bendamustine has on subjects and their lymphoma compared to rituximab plus bendamustine alone.
2) In step 2, to find out what effects, good and bad, continuing treatment after step 1 with lenalidomide plus rituximab has on subjects and their lymphoma compared to continuing treatment with rituximab alone.
Subjects will receive one of the following regimens:
1) Step 1 rituximab plus bendamustine, followed by step 2 rituximab
2) Step 1 bortezomib plus rituximab plus bendamustine, followed by step 2 rituximab
3) Step 1 rituximab plus bendamustine, followed by step 2 lenalidomide plus rituximab.
4) Step 1 bortezomib plus rituximab plus bendamustine, followed by step 2 lenalidomide plus rituximab
These regimens are experimental and have not been approved by the FDA for use in patients with untreated mantle cell lymphoma, although each of the drugs used in the study is FDA approved for certain blood cancers.

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

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
May 23rd, 2013
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

Phase II Randomized Study of Whole Brain Radiotherapy in Combination with Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer ? A COLLABORATIVE STUDY OF RTOG AND KROG Save

Date Added
May 7th, 2013
PRO Number
Pro00025233
Researcher
Patricia Griffin
Keywords
Cancer, Cancer/Brain, Drug Studies
Summary

The purpose of this study is to compare the effects of adding lapatinib to standard whole brain radiation therapy (WBRT). The study will try to find out whether WBRT or lapatinib plus WBRT is better at safely improving tumor control. In this study, subjects will receive either lapatinib plus WBRT or WBRT alone.

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

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

Enhancing disrupted reconsolidation: Impact on cocaine craving, reactivity & use Save

Date Added
December 4th, 2012
PRO Number
Pro00021392
Researcher
Michael Saladin
Keywords
Drug Studies, Mental Health, Psychiatry, Substance Use
Summary

Our recently completed study has provided the first evidence that administration of the medication propranolol, following exposure to cocaine cues, can alter drug-associated memories and reduce craving and other drug cue-elicited responses in cocaine addicted persons. The proposed research will use two methods to increase the memory altering effects of propranolol observed in our recently completed study, and document lasting effects not only on craving and cue-elicited reactions, but also on cocaine use. Positive findings will set the stage for a formal clinical trial that could lead to significantly improved treatment outcomes for this treatment-resistant addiction.

Institution
MUSC
Recruitment Contact
Amanda Smith
843-792-6984
smitham@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
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

A Randomized Phase II Trial of Ofatumumab and Bendamustine (NSC #681239, IND #58443) vs. Ofatumumab, Bortezomib and Bendamustine in Patients with Untreated Follicular Lymphoma Save

Date Added
August 7th, 2012
PRO Number
Pro00018706
Researcher
James Bearden
Keywords
Cancer/Lymphoma, Drug Studies
Summary

The purpose of this study is to find out what effects (good and/or bad) treatment with the combination of ofatumumab and bendamustine or the combination of ofatumumab, bendamustine, and bortezomib has on patients and their lymphoma. The combination of these drugs has not been approved for use in follicular lymphoma by the FDA. The use of this combination of drugs in this study is considered experimental.

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

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