LEAHRN (Late Effects After High-Risk Neuroblastoma) Study Save

Date Added
July 14th, 2018
PRO Number
Pro00080522
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Cancer, Cancer/Brain, Pediatrics
Summary

This study is for patients who have been diagnosed with high-risk neuroblastoma. The purpose of this study is to learn if the treatment you received for your high-risk neuroblastoma has affected your health overtime. Participants can expect to be in this study for up to 12 weeks.

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

METIS: Pivotal, Open-Label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases From Non-Small Cell Lung Cancer (NSCLC). Save

Date Added
March 13th, 2018
PRO Number
Pro00074473
Researcher
Scott Lindhorst

Silhouette
Keywords
Cancer/Brain, Cancer/Lung
Summary

To test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1 inoperable brain metastasis or 2-10 brain metastases, treated with NovoTTF-100M and supportive treatment compared to supportive treatment alone.
Participants will be randomized to the Supportive Care Group and will receive radiosurgery followed by supportive care, or to the NovoTTF-110M group who will receive radiosurgery then begin using the study device with supportive care. The device is to be worn at least 18 hours every day. There is a provision for those randomized to the supportive care arm to crossover to the study device after tumor has recurred twice. All participants will be seen every 8 weeks in the clinic until they progress a second time. Once study treatment is terminated, they will return to the clinic 8 weeks following the last visit, then be contacted once per month by telephone.

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

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

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

URCC 14040: A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral therapy for Treating Insomnia in Cancer Survivors Save

Date Added
March 15th, 2016
PRO Number
Pro00053106
Researcher
Jeffrey Giguere
Keywords
Cancer, Cancer/Brain, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Leukemia, Cancer/Lung, Cancer/Lymphoma, Cancer/Myeloma, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Education, Exercise, Sleep Disorders
Summary

This research study is for patients who have completed all scheduled surgery, chemotherapy and/or radiation therapy for their cancer within the last 6-12 months and are currently having some type of sleep disturbance. While there is no standard treatment for sleep disturbance for cancer survivors, people who do not take part in this study may take over-the-counter or prescription medications, receive cognitive behavioral therapy, or exercise as a means of attempting to manage their sleep problems.

Sleep disturbance, particularly insomnia, is a common problem for cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than you would like. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as your biological clock) to be disrupted and decrease quality of life.

Because there is no ideal standard of care for effectively treating sleep problems in cancer survivors, the purpose of this study is to compare the effectiveness of three different treatments for improving sleep problems and determine which is best. The three treatments are yoga, survivorship health education, and cognitive behavioral therapy (CBT-I).

Study participation will be approximately 8 months.

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
gnorris@ghs.org

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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