Phase Ib/II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies Save

Date Added
August 22nd, 2017
PRO Number
Pro00066806
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Adolescents, Brain Tumor, Cancer, Cancer/Brain
Summary

This study is for patients that have been diagnosed with Central Nervous System (CNS) Tumors. The investigational drugs in this study are Nivolumab and Ipilimumab. The purpose of this study is to test the effectiveness, safety, and tolerability of Nivolumab when given alone or when combined with Ipilimumab. The duration of patient participation may be more than 3 years. If enrolled in treatment, the exact length of time will depend on the patients response to treatment.

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

Assessing the Impact of Glioblastoma Multiforme on the Quality of Life of Patients and Caregivers (The GlioQoL Observational Study) Save

Date Added
July 17th, 2017
PRO Number
Pro00067538
Researcher
David Cachia

Silhouette
Keywords
Brain Tumor, Cancer/Brain
Summary

The purpose of conducting this observational research study is to gain a better understanding of the impact of GBM on patients and their caregivers at specific time points during treatment. In addition, this study will also examine the approaches currently employed to treat GBM at cancer centers, and how those approaches vary across the course of the disease. As a caregiver of a patient with GBM, participation in this study will provide insights into caregiver quality of life and burden, and how it is affected by GBM.

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

Silhouette
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

Augmentation of immune response against glioblastoma by intradermal administration of irradiated tumor cell hybrids: a Phase II clinical trial with safety lead-in. Save

Date Added
December 20th, 2016
PRO Number
Pro00058836
Researcher
Sebastiano Gattoni-celli

Silhouette
Keywords
Brain Tumor, Cancer/Brain, Glioblastoma
Summary

Patients diagnosed with glioblastoma multiforme, the most severe brain tumor,
will undergo standard treatment. This treatment is (a) surgery to remove as much of the tumor as possible and (b) radiation/chemotherapy. This study will collect some of the tumor when the surgical procedure is performed. The tumor tissue will then be processed and developed into a patient specific cancer vaccine. This will take about seven weeks. The patient will then receive their patient-specific vaccine for a total of 10 doses over a period of 16 weeks. Hopefully, the vaccine will prevent any resultant GBM tumor cells from recurring, thus extending survival rates.

Institution
MUSC
Recruitment Contact
Linda Ambrose
843-789-7816
linda.ambrose@va.gov

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

Silhouette
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 II RANDOMIZED STUDY OF WHOLE BRAIN RADIOTHERAPY/STEREOTACTIC RADIOSURGERY IN COMBINATION WITH CONCURRENT LAPATINIB IN PATIENTS WITH BRAIN METASTASIS FROM HER2-POSITIVE BREAST CANCER - A COLLABORATIVE STUDY OF NRG ONCOLOGY 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

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

A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma and Relapsed Medulloblastoma Save

Date Added
October 5th, 2010
PRO Number
Pro00007324
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Cancer/Brain, Cancer/Other, Pediatrics
Summary

The study is being done to test how well nifurtimox works against neuroblastoma and medulloblastoma in children. Early observation and testing suggest that nifurtimox has effect against these types of cancer. Nifurtimox is well tolerated by children and doesn't seem to have long term side effects when used to treat Chagas' disease. The goal of the study is to learn if nifurtimox in combination with other chemotherapy drugs is effective in shrinking/killing neuroblastoma and medulloblastoma cells.

Institution
MUSC
Recruitment Contact
Elizabeth Rackoff
843-792-3379
rackoffe@musc.edu

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