PHASE III TRIAL OF SALVAGE STEREOTACTIC RADIOSURGERY (SRS) OR SRS + HIPPOCAMPALAVOIDANT WHOLE BRAIN RADIOTHERAPY (HA-WBRT) FOR FIRST OR SECOND DISTANT BRAIN RELAPSE AFTER UPFRONT SRS WITH BRAIN METASTASIS VELOCITY ≥4 BRAIN METASTASES/YEAR

Date Added
August 4th, 2022
PRO Number
Pro00122545
Researcher
Charlotte Rivers

List of Studies


Keywords
Cancer/Brain
Summary

This study is for men or women who received stereotactic radiosurgery to treat cancer that spread to their brain, and now the cancer has returned in other areas of the brain. This study is being done to see if by adding radiation therapy called whole-brain radiation therapy that avoids the hippocampus to preserver memory plus medication approved to treat dementia can extend these patients lives.

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

A SAFETY RUN-IN AND PHASE II STUDY EVALUATING THE EFFICACY, SAFETY, AND IMPACT ON THE TUMOR MICROENVIRONMENT OF THE COMBINATION OF TOCILIZUMAB, ATEZOLIZUMAB, AND FRACTIONATED STEREOTACTIC RADIOTHERAPY IN RECURRENT GLIOBLASTOMA

Date Added
May 12th, 2022
PRO Number
Pro00120398
Researcher
Alicia Zukas

List of Studies

Keywords
Cancer/Brain, Glioblastoma
Summary

This study is for men and women with recurrent glioblastoma. The purpose of the study is to see if adding immune therapy drugs to usual radiation therapy can shrink or stabilize brain cancer.

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

Phase II Trial of Eflornithine/DFMO as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma

Date Added
February 1st, 2022
PRO Number
Pro00113673
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for participants that have been diagnosed with Medulloblastoma. The purpose of this study is to test the effectiveness of using an investigational agent called DFMO for Medulloblastoma. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the ability of this study drug to either keep participants tumor in remission or if they have active tumor, for their tumor to respond to the treatment and will also look at the safety and tolerability of DFMO. After this first day participants will be seen in clinic once every 30 days for the first 6 months of the study, after that they will be seen once every 90 days for the remainder of the study. These visits will last about 2 hours.

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

Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for 10 or Fewer Brain Metastases From Small Cell Lung Cancer

Date Added
June 23rd, 2021
PRO Number
Pro00110550
Researcher
Charlotte Rivers

List of Studies


Keywords
Cancer, Cancer/Brain, Cancer/Lung
Summary

This study is for participants that have been diagnosed with small cell lung cancer, that has spread to the brain. The purpose of this study is to see if high dose radiation therapy delivered only to the small areas of brain cancer and avoiding the surrounding normal brain tissue, called stereotactic radiosurgery (SRS), decrease side effects related to memory and thinking compared to radiation to the entire brain, called, whole-brain radiation therapy (WBRT) that avoids the hippocampus but treats all of the brain tissue along with a drug that helps preserve memory and thinking called memantine. Participants can expect to be on this study for up to 6 months, depending on what treatment they receive (SRS alone or HA-WBRT with memantine). Participants will then be followed every 2 to 3 months for at least 1 year after study completion and then every 6 months for their lifetime or until disease progression.

Institution
MUSC
Recruitment Contact
Lydia Moats, Research Coordinator
864-725-7125
lydia.moats@selfregional.org

Phase II Trial of the Immune Checkpoint Inhibitor Nivolumab in Patients With Select Rare CNS Cancers

Date Added
March 16th, 2021
PRO Number
Pro00107606
Researcher
Scott Lindhorst

List of Studies


Keywords
Cancer/Brain
Summary

This study is for patients with rare Central Nervous (brain or spine) tumors. The purpose of this study is to determine whether the experimental drug, nivolumab can shrink tumors in patients with rare Central Nervous System (brain or spine) tumors or increase the time it takes for these tumors to grow or spread throughout the body.

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

67Cu-SARTATE Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma: A Multi-center, Dose-escalation, Open-label, Non-randomized, Phase 1-2a Theranostic Clinical Trial

Date Added
February 9th, 2021
PRO Number
Pro00105726
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for participants that have been diagnosed with a high-risk neuroblastoma that cannot be treated or did not improve with existing therapies, or the cancer came back after treatment with existing therapies. This study involves investigational drugs called 64Cu-SARTATE and 67Cu-SARTATE. The investigational drugs will be given as an IV injection. The study is divided into 2 parts: The Dose Escalation Phase and the Cohort Expansion Phase. The phase that participants will enroll to will depend on when they enter the study. The age range for participants is from 12 months to 25 years. Participants can expect to be in this study for approximately 14 months. Then followed by remote or virtual visits every 6 months for up to 36 months (3 years) after the initial dose of study therapy drug 67Cu-SARTATE.

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

EF-32 (TRIDENT): A Pivotal Randomized, Open-Label Study of Optune® (TTFIELDS, 200KHZ) Concomitant with Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

Date Added
February 9th, 2021
PRO Number
Pro00106190
Researcher
Scott Lindhorst

List of Studies


Keywords
Brain Tumor, Cancer/Brain, Glioblastoma, Men's Health, Women's Health
Summary

This trial is for newly diagnosed glioblastoma (GBM) patients who, after surgery or biopsy, are good candidates for radiation therapy (RT) and temozolomide (TMZ) treatments. The purpose of this study is to see how safe and how well a medical device called Optune works together with the other standard of care treatments for GBM (RT and TMZ). Optune is a device that uses Tumor Treating Fields (TTFields) which are low intensity electric fields that interfere with the division process of cancer cells. Optune has been approved for the treatment of recurrent and newly diagnosed GBM by the Food and Drug Administration (FDA) in the United States. Participants in this study will be randomly assigned to one of two groups:
-The Experimental Group: TTFields using the Optune system upfront with RT and TMZ followed by the use of Optune and TMZ
-The Control Group: Beginning treatment of RT and TMZ, followed by the use of Optune and TMZ
Patients will have clinic visits every 4 weeks and continue on TTFields for 24 months until their disease gets worse or they or their doctor decided to stop treatment.

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

A Phase III Trial of Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5-15 Brain Metastases

Date Added
November 25th, 2019
PRO Number
Pro00094385
Researcher
Scott Lindhorst

List of Studies


Keywords
Cancer/Brain
Summary

This study is for patients with brain cancer. This study is being done to see if by using stereotactic radiosurgery can reduce symptoms and lower the chance of the cancer growing compared to the ususal radiotherapy.

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study

Date Added
November 19th, 2018
PRO Number
Pro00083220
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Cancer/Brain, Pediatrics
Summary

This study is for pediatric patients who have been diagnosed with Brain Tumors. The purpose of this study is to assess the feasibility of a home-based, computerized cognitive training program for patients with pediatric brain tumors who are undergoing cranial radiation therapy (CRT). Participants can expect to receive treatment on this study for about 5 to 9 weeks. Participants will complete additional testing sessions about 6 months after completing the cognitive training program.

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

A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

Date Added
October 8th, 2018
PRO Number
Pro00082422
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for patients who have been diagnosed with a neuroblastoma (NBL). The purpose of this study is to find out if we can improve the treatment for subjects with high-risk NBL by adding the experimental drug 131I-MIBG or the experimental drug Crizotinib to recommended therapy. The secondary purpose is to find out if we can reduce the number of stem cell transplants from two to one if we give the experimental drug 131I-MIBG during Induction, and use different drugs as part of the transplant chemotherapy given prior to stem cell infusion during Consolidation. Participants can expect to be in this study for up to 2 years. Researchers would like to continue to follow participants health for up to 10 years.

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



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