A RANDOMIZED PHASE III TRIAL OF PRE-OPERATIVE COMPARED TO POST-OPERATIVE STEREOTACTIC RADIOSURGERY IN PATIENTS WITH RESECTABLE BRAIN METASTASES

Date Added
January 25th, 2023
PRO Number
Pro00126162
Researcher
Charlotte Rivers

List of Studies


Keywords
Cancer/Brain
Summary

This study is for patients with brain cancer. The study is being done to see if giving radiation before surgery will improve the length of time without the cancer returning, worsening or causing scarring in the brain.

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

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

A Phase 3 Randomized Study of Selumetinib (IND # 77782) Versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)

Date Added
February 23rd, 2022
PRO Number
Pro00118178
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for newly diagnosed previously untreated neurofibromatosis type 1 (NF1) associated with low-grade glioma (LGG). The purpose of this study is to see if selumetinib works just as well as the standard treatment of carboplatin/vincristine (CV) for subjects with NF1-associated LGG, and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway. Participants can expect to receive treatment for up to 24 months, until the cancer gets worse or until the side effects are too great. After study completion, participants will continue to be followed for up to 10 years.

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

A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)

Date Added
February 22nd, 2022
PRO Number
Pro00118193
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for newly diagnosed or previously untreated low-grade glioma (LGG). The overall goal of this study is to see if selumetinib works just as well as the standard treatment using carboplatin and vincristine (called CV) for subjects with LGG. Selumetinib is a drug that works by blocking a protein (a basic building block of the human body) that lets cancer cells grow without stopping. Participants can expect to receive treatment on this study for about 1–2 years. After study completion, participants will continue to be followed for up to 10 years.

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 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



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