OLANZAPINEWITH ORWITHOUT FOSAPREPITANT FOR THE PREVENTION OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING (CINV) IN PATIENTS RECEIVING HIGHLY EMETOGENIC CHEMOTHERAPY (HEC): A PHASE III RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED TRIAL Save

Date Added
March 1st, 2019
PRO Number
Pro00086739
Researcher
Scott Lindhorst

List of Studies


Profiles_link
Keywords
Cancer
Summary

This study is for patients receiving treatment for cancer that may cause side effects of nausea and vomiting. The purpose of this study is to see if olanzapine given in combination with other standard drugs, is still as effective without using the fosaprepitant.

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-5105
nmcgaha@selfregional.org

A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy Save

Date Added
February 19th, 2019
PRO Number
Pro00086308
Researcher
Scott Lindhorst

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Brain, Glioblastoma
Summary

This study is for men and women with glioblastoma. The purpose is to see if we can lower the chance of memory loss by adding the drug Ramipirl to the usual chemoradiation treatment.

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

List of Studies


Profiles_link
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

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

List of Studies


Profiles_link
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

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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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

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

List of Studies


Profiles_link
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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