Open-Label, Randomized,, Controlled, Phase 3 Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) with Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Patients Save

Date Added
January 23rd, 2018
PRO Number
Pro00074342
Researcher
Scott Lindhorst

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Keywords
Glioblastoma
Summary

To assess the safety and efficacy of Trans Sodium Crocetinate (TSC) as first-line treatment for biopsy-only GBM when administered with the standard of care consisting of radiation therapy/temozolomide for 6 weeks, followed by 28 day rest followed by post-radiation temozolomide-only treatment for six 28 day cycles.

Institution
MUSC
Recruitment Contact
John Keller
843-792-2209
kellej@musc.edu

Phase II Trial of Optune® Plus Bevacizumab in Bevacizumab-Refractory Recurrent Glioblastoma Save

Date Added
February 28th, 2017
PRO Number
Pro00061943
Researcher
David Cachia

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Keywords
Cancer/Brain, Glioblastoma
Summary

This study is for patients 22 and older with a glioblastoma (a type of brain tumor) that has grown back (recurred) or not gotten better after being treated with bevacizumab. The purpose of this study is to test any good and bad effects of adding bevacizumab to a type of therapy for brain tumors called Optune. Optune is a portable device that produces electrical signals, called Tumor Treating Fields ("TTFields"). Optune is a portable device worn on the patients head that send wave-like electric signals directly to their tumor. The device will be worn continuously throughout the day for at least 18 hours a day with breaks allowed for personal needs.

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

A Randomized Phase 2 Single Blind Study of Temozolomide plus Radiation Therapy combined with Nivolumab or Placebo in Newly Diagnosed Adult Subjects with MGMT-Methylated (tumor O6-methylguanine DNA methyltransferase) Glioblastoma Save

Date Added
May 10th, 2016
PRO Number
Pro00054905
Researcher
Scott Lindhorst

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Keywords
Brain Tumor, Cancer/Brain, Drug Studies, Glioblastoma
Summary

You are invited to volunteer for a research study because you previously consented to participate in a companion study BMS 498, but did not meet eligibility criteria for MGMT status; therefore, you are newly diagnosed with glioblastoma and the tumor has a specific profile that is referred to as MGMT methylated.

This study will test the effectiveness, safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow your body's immune system to work against tumor cells.You will also receive standard radiation therapy in unison with temozolomide and the study drug treatment, nivolumab or placebo.

Institution
MUSC
Recruitment Contact
Michele DeCandio
843-792-9016
decandio@musc.edu

A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination with Radiation Therapy in Newly Diagnosed Adult Subjects with Unmethylated MGMT (tumor O6-methylguanine DNA methyltransferase) Glioblastoma Save

Date Added
February 23rd, 2016
PRO Number
Pro00051457
Researcher
Scott Lindhorst

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Keywords
Brain Tumor, Cancer/Brain, Drug Studies, Glioblastoma
Summary

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells. The effectiveness of nivolumab in glioblastoma (GBM or brain cancer) will be determined by comparing the survival of subjects who receive the investigational drug nivolumab combined with radiotherapy to those who receive temozolomide with radiotherapy, an accepted therapy for newly diagnosed GBM.

If you agree to be in this study, a biopsy of your tumor will tested for a specific gene. If you have that gene, you will be eligible to participate in the study. In addition to taking either nivolumab or temozolomide in combination with radiotherapy you will be asked to complete other study procedures. Those study procedures may include physical exams, medical history, blood draws, MRI scans, questionnaires.

Institution
MUSC
Recruitment Contact
John Keller
843-792-2209
kellej@musc.edu

A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1) Save

Date Added
November 10th, 2015
PRO Number
Pro00049546
Researcher
David Cachia

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Keywords
Cancer, Glioblastoma, Men's Health, Women's Health
Summary

The main purpose of this study is to research the investigational drug (not yet approved by the Food and Drug Administration), ABT414. Human studies have shown ABT-414 can shrink EGFR (epidermal growth factor receptor)-amplified glioblastomas (GBM's) in some people whose tumors were growing despite earlier RT (radiation) and chemotherapy treatment. This investigational drug will be given at the same with radiation therapy and the FDA approved chemotherapy drug, temozolomide.
If the subject meets the study requirements and agrees to volunteer, they will be on the study for approximately 2 years, and will be asked to go to study visits every 2 weeks.
Approximately 720 subjects will be asked to take part, 8 of them will be at MUSC.

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

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