Phase II Trial of Molecularly Determined Treatment of Children and Young Adults with Newly Diagnosed Diffuse Intrinsic Pontine Gliomas. Save

Date Added
September 1st, 2015
PRO Number
Pro00036212
Researcher
Amy-lee Bredlau
Keywords
Brain Tumor, Cancer/Brain, Drug Studies, Pediatrics
Summary

This research study will seek to assign a specific drug treatment based upon pre-treatment characteristics of study subject's tumor obtained from biopsy material taken at the original diagnosis. Specifically, in this research study, they are observing to see how well bevacizumab and radiation, followed by bevacizumab with or without temozolomide and/or erlotinib, works on the study subject's tumor.

Institution
MUSC
Recruitment Contact
Kate McCormack
843-876-8481
mccormk@musc.edu

Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma Save

Date Added
August 20th, 2015
PRO Number
Pro00030091
Researcher
Patricia Griffin
Keywords
Cancer, Cancer/Brain, Drug Studies
Summary

Bevacizumab is a commercially available drug that is FDA approved for the treatment of glioblastoma that has returned after treatment (recurrent glioblastoma). However, treatment with bevacizumab alone has only modestly improved survival in patients with this type of brain tumor. For this reason, researchers are evaluating other treatments, including bevacizumab combined with radiation.

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.

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

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
August 20th, 2015
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

Phase II Trial of Intravenous Fenretinide (N-(4-hydroxyphenyl) retinamide, 4-HPR) Emulsion for Patients with Relapsed/Refractory Peripheral T-cell Lymphomas (PTCL) Save

Date Added
August 11th, 2015
PRO Number
Pro00045977
Researcher
Saurabh Chhabra
Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with cancer, specifically a T-cell lymphoma. The investigational drug in this study is 4-HPR. The purpose of this study is to see what effects fenretinide will have on your tumor. Participants can expect to be in this study for up to two years.

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

A Phase II Randomized Trial to Assess the Effectiveness and Safety of the ID-Cap System for Medication Management Monitoring and Enhancing Adherence Save

Date Added
August 4th, 2015
PRO Number
Pro00033472
Researcher
Aimee Mc Rae
Keywords
Drug Studies, Substance Use
Summary

Approximately 40 healthy male and female patients, ages 18 to 65, will participate in this study. The primary objective of the study is to evaluate the acceptability, tolerability, and efficacy of administering capsules with built-in, ingestible computer chips to healthy people The primary outcome will be medication compliance as measured by the proportion of days adherent to taking medication over a 30 day period.

Institution
MUSC
Recruitment Contact
Amanda Wagner
843-792-0484
wagne@musc.edu

A phase 2 study of brentuximab vedotin in combination with standard of care treatment (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [RCHOP]) or RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) as front-line therapy in patients with diffuse large B-cell lymphoma (DLBCL) Save

Date Added
July 28th, 2015
PRO Number
Pro00045219
Researcher
Saurabh Chhabra
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with diffuse large B-cell lymphoma (DLBCL), which has never been treated. The drug in this study is brentuximab vedotin. The purpose of the first part of the study was to test the safety and effectiveness of 2 different doses of brentuximab vedotin when given with a combination of drugs called RCHOP [rituximab, cyclophosphamide, hydroxydaunorubicin (also called doxorubicin), vincristine (Oncovin), and prednisone]. The purpose of the second part of the study is to test the safety and effectiveness of brentuximab vedotin when given with a combination of drugs that does not include vincristine called RCHP [rituximab, cyclophosphamide, hydroxydaunorubicin (also called doxorubicin), and prednisone]. Participants can expect to be in this study for up to 2-3 years.

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

A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Save

Date Added
July 28th, 2015
PRO Number
Pro00045834
Researcher
Patrick Flume
Keywords
Cystic Fibrosis, Drug Studies, Lung, Pediatrics, Pulmonary
Summary

This study will evaluate the safety and effects of Lumacaftor (661) in combination with Ivacaftor (770) over 32 weeks in subjects with Cystic Fibrosis 6 to 11 years old who are homozygous for the F508del CFTR Mutation.

The study will consist of two treatment groups: active drug and placebo, with a optional rollover portion to receive active drug only after 24 weeks.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

Recombinant Von Willebrand Factor (rVWF) A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE rVWF IN SUBJECTS WITH SEVERE VWD UNDERGOING SURGERY Save

Date Added
July 14th, 2015
PRO Number
Pro00038525
Researcher
John Lazarchick
Keywords
Blood Disorders, Drug Studies, Rare Diseases, Surgery
Summary

This study is for patients with von Willebrand Disease undergoing surgical procedures. The study drug, recombinant von Willebrand Factor, will be used with or without Advate (Factor VIII) in the pre-, peri-, and post- operative timeframe to prevent abnormal bleeding episodes. Participation in the study is expected to last 8-15 weeks.

Institution
MUSC
Recruitment Contact
Caroline Vaughn
843-792-2348
vaughncd@musc.edu

Multicenter, Open-label, Single-arm, Study of Enzalutamide Re-Treatment in Metastatic Castration-Resistant Prostate Cancer, As First Treatment Post-Decetaxel in Patients Who Have Previously Received Enzalutamide in the Pre-Chemotherapy Setting Save

Date Added
July 14th, 2015
PRO Number
Pro00044714
Researcher
Michael Lilly
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for patients that have been diagnosed with metastatic castration-resistant prostate cancer and have been previously treated with enzalutamide followed by docetaxel. This experimental study is being done to study the effectiveness and safety of enzalutamide when it is administered as re-treatment, following prior enzalutamide use and treatment with docetaxel. The length of time that patients are in the study will depend on their tolerance of the study medication and the state of their disease. They will continue in the study until they show signs of disease progression or unacceptable toxicity of the study medication.

Institution
MUSC
Recruitment Contact
Mike Wheeler
843-792-2306
wheelerm@musc.edu

A Phase 2b Multicenter, Single Dose, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Evaluating the Safety and Efficacy of Two Doses of Stannsoporfin in Combination with Phototherapy in Neonates. Save

Date Added
July 14th, 2015
PRO Number
Pro00026822
Researcher
Carol Wagner
Keywords
Drug Studies, Infant
Summary

This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled parallel group safety and efficacy trial of two doses of stannsoporfin administered as a single intramuscular injection in combination with phototherapy in term and near term infants.

Institution
MUSC
Recruitment Contact
Deanna Fanning
843-792-7021
fanningd@musc.edu

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