The University of North Carolina has a robust brain tumor research program. Well over a dozen labs in the Lineberger Comprehensive Cancer Center explore Brain Tumor Research at UNC Health the diagnosis and novel treatment of brain tumors. Immunotherapy and cellular therapy are actively being investigated both in the laboratory setting and clinical trials. There is particular institutional expertise in genetic profiling of brain tumors, the study of IDH1, IDH1’s role in brain tumors and advanced imaging of brain tumors within the Biomedical Research Imaging Center (BRIC).

Brain Tumor Clinical Trials at UNC Medical Center

Glioblastoma (GBM) is the most common and aggressive primary brain tumor in adults. The standard of care for glioblastoma remains unchanged since 2005. Dr. Soma Sengupta and Dr. Yasmeen Rauf research focus is on the management and treatment of GBM. While Dr Sengupta focuses on commercial clinical trials and Dr. Rauf on cellular therapy clinical trials, both neuro oncologists collaborate in their research, and in the treatment of brain tumor patients at UNC Health.

The following brain tumor clinical trials are open and enrolling patients at UNC Health:

CAR-T Clinical Trial

Dr. Yasmeen Rauf is leading clinical trials to determine a more effective way to treat patients with GBM. The study will evaluate the safety and tolerability of CAR-T immunotherapy, a very promising therapy for patients with recurrent or progressive glioblastoma.

CAR-T Clinical Trial Contact:
Catherine Cheng
Phone: 919-445-4208
catherine_cheng@med.unc.edu

Request to Join the Study

SONOBIRD Clinical Study

UNC is now enrolling patients in the multicenter, multinational SONOBIRD phase III clinical trial. The clinical trial evaluates the use of a device called SonoCloud®, which can more effectively deliver chemotherapy through the brain to treat malignant brain tumors. This study is open to glioblastoma patients with their first recurrence. The clinical trial at UNC Health is led by neurosurgical oncologist, Dr. Dominique Higgins.

SONOBIRD Clinical Study Contact:

Camisha Johnson
Phone: 919-445-4847
camisha_johnson@med.unc.edu

Dr. Dominique Higgins
higginsd@unc.edu

Request to Join the Study

BT015/LIBERATE Clinical Study

The BT015/LIBERATE study is now open at UNC for patients with newly diagnosed or recurrent glioblastoma. The study will temporarily disrupt the blood-brain barrier using focused ultrasound, facilitating liquid biopsies in patients with glioblastoma.

BT015/LIBERATE Clinical Study Contact:

Camisha Johnson
Phone: 919-445-4847
camisha_johnson@med.unc.edu

Request to Join the Study

Phase II Clinical Trial of Ropidoxuridine

The Phase II clinical trial of Ropidoxuridine, a radiation sensitizer developed by Shuttle Pharma, is enrolling patients with newly diagnosed with glioblastoma. The drug aims the enhance the positive effects of radiation therapy for patients with unmethylated MGMT glioblastoma. The study is led by Dr. Soma Sengupta.

Phase II Clinical Trial of Ropidoxuridine Contact:

Camisha Johnson
Phone: 919-445-4847
camisha_johnson@med.unc.edu

Request to Join the Study

Expanded Access to Gallium Maltolate (GaM)

Expanded Access Program for a new cancer therapy for patients with recurrent glioblastoma (GBM) that is now available at three different locations in the United States. The study is for patients with recurrent GBM, and who meet the eligibility criteria and cannot access the phase 1 clinical trial for the investigation of GaM.

Expanded Access to Gallium Maltolate (GaM) contact:

Camisha Johnson
Phone: 919-445-4847
camisha_johnson@med.unc.edu

Request to Join the Study

Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma

Patients with methylated MGMT promoter glioblastomas will be randomized into two groups and will receive either a combination of lomustine and temozolomide or temozolomide alone during radiation therapy.

Study contact:

Amalia Postier
Phone: 919-966-5485
amalia_postier@med.unc.edu

Request to Join the Study

Stereotactic Radiosurgery w/ DDR Inhibitor (Olaparib) Followed by Adjuvant Durvalumab & Chemotherapy

Patients with brain metastases and triple negative breast cancer will be given olaparib (oral chemotherapy) during radiation followed by a combination of immunotherapy (durvalumab) and physician’s choice of systemic chemotherapy. This study also offers the option to participate in a surgical sub-study where participants only receive olaparib prior to tumor resection and are not given immunotherapy/chemotherapy.

Study contact:

Amalia Postier
Phone: 919-966-5485
amalia_postier@med.unc.edu

Request to Join the Study

Genetic Testing in Guiding Treatment for Patients With Brain Metastases

For patients with solid tumors and brain metastases, genetic testing of brain tumor is used to guide treatment plan. Patients will be assigned to 1 of 4 oral chemotherapy options based on genetic mutation pathway.

Study contact:

Amalia Postier
Phone: 919-966-5485
amalia_postier@med.unc.edu

Request to Join the Study

Nivolumab plus or minus Ipilimumab in Combination with Multi-fraction Stereotactic Radiosurgery for Recurrent High-grade Radiation-relapsed Meningioma

Patients with relapsed/recurrent Grade 2 to 3 meningioma, who have already received radiation therapy and surgery, will be randomized to one of two immunotherapy treatment groups. One treatment arm will receive a combination of immunotherapies (nivolumab + ipilimumab) and the other treatment arm will receive only one type of immunotherapy (nivolumab alone) during reirradiation.

Study contact:

Amalia Postier
Phone: 919-966-5485
amalia_postier@med.unc.edu

Request to Join the Study

What is CAR-T immunotherapy?

CAR-T is a process that involves extracting T cells from patients, manufacturing the cells in the lab to identify tumor cells displaying a specific molecular target, and then re-infusing the cells to fight a patient’s cancer.

In human beings, when the immune system finds an abnormal cell, it creates a millions of T cells to kill the abnormal cell, trying not to harm the healthy cells. T cells have receptors on its surface. These claw-like receptors attach to the antigen. Once they attach, if they identify the antigen presenting cell as abnormal, it releases toxins to damage the cell. Cancer cells evade this immune response. CAR- T immunotherapy is used to help our body’s natural defense army to recognize cancer cells as abnormal cells and mound a response against them.

CAR-T clinical trials at UNC Medical Center

How does CAR-T work?

Modified and inactive viruses are used to change genetic information in a patient’s own T cell. The T cells are then programmed so that they now have ‘Chimeric Antigen Receptors’. The new receptors enable the T cells to latch onto the patient-specific antigen on the tumor cells and destroy them.

CAR-T Immunotherapy at UNC Lineberger

CAR-T immunotherapy at UNC Lineberger is one of a select few academic centers in the United States with the scientific, technical and clinical capabilities to identify new tumor targets and then develop and infuse novel CAR-T immunotherapy. CAR- T is manufactured at UNC, making the turnaround time as low as 24 hours compared to other centers using commercial CAR-T where the turnaround time between decision to pursue CAR-T and first treatment can be up to one month.

UNC Lineberger opened its advanced cellular therapeutics facility in 2015. The facility, which is certified to use Current Good Manufacturing Practices as set by the FDA, is located approximately five miles off campus. In this facility, cellular therapy products are generated and expanded for patients receiving adoptive cell therapy for the treatment of cancer.

For more information on brain tumor research at UNC Medical Center, please contact:
Dominique Higgins, MD, PhD
Neurosurgical Oncologist
Assistant Professor, UNC Department of Neurosurgery
Email: higginsd@unc.edu
Phone: 984-974-4175