A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy STELLAR Study Save

Date Added
July 12th, 2016
PRO Number
Pro00056376
Researcher
Scott Lindhorst

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

Subjects are being asked to volunteer for a research study because they have their first anaplastic astrocytoma (AA) tumor progression (worsening) or recurrence.

The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Eflornithine is an experimental drug that the United States Food and Drug Administration (FDA) has not approved it for use by the general public. Lomustine has been approved by the FDA in the United States for this patient population.

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

Silhouette
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

Silhouette
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

Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas Save

Date Added
March 12th, 2011
IRB Number
19663
Researcher
Scott Lindhorst

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

This study is for patients with a low grade glioma (a slow growing tumor in the brain). The purpose of this study is to compare the effects, good and/or bad, of adding the chemotherapy pill temozolomide to radiation. Temozolomide is an experimental drug for low-grade gliomas. Patients will be randomly assigned to 1 of 2 groups. One group will receive radiation alone, while the other group receives Temozolomide chemotherapy in addition to the radiation. Patients will receive radiation for 5.5 weeks; patients may also take temozolomide during the 5.5 weeks of radiation and for up to one year thereafter. Follow-up exams will occur every 3 months for 15 years.

Institution
MUSC
Recruitment Contact
Bo Keller
843-792-1286
Kellej@musc.edu

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