Experimental therapy is available to patients with recurrent glioblastoma that did not respond to standard-of-care therapies, demonstrating UNC Lineberger’s continued commitment to brain tumor research.

The FDA has approved an expanded access program for an experimental therapy for patients with recurrent glioblastoma (GBM). It is now available at three locations in the United States, including at the UNC Lineberger Comprehensive Cancer Center.

The expanded access program is open to physicians who are caring for a patient whose cancer has failed to respond to standard-of-care therapies, meets the eligibility criteria, and cannot access the phase 1 clinical trial for the investigation of gallium maltolate.

Gallium maltolate, created by Imaging Biometrics, will be provided as 500 mg capsules and will be self-administered once daily by mouth for at least three months. UNC Lineberger is the only location in the Southeastern U.S. participating in the expanded access program.

Gallium maltolate has demonstrated early efficacy for patients with various malignancies. Researchers at UNC Lineberger will collect information on how each patient responds to the experimental drug. “It is important to provide access for patients to expanded access programs, and more options for recurrent GBM,” said Dr. Soma Sengupta, division chief of neuro-oncology in the Department of Neurosurgery at UNC School of Medicine.

The FDA’s expanded access program allows patients with serious or immediately life-threatening diseases or conditions to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. GBM patients have an average survival of 15 to 18 months after diagnosis. Fast and effective treatment for GBM patients can improve quality-of-life and potentially prolong life.

The gallium maltolate expanded access program is partially supported by the Musella Foundation for Brain Tumor Research and Information, Inc.

Patients interested in participating in the study should contact Camisha Johnson, 919-445-4847 or camisha_johnson@med.unc.edu.

Written by Makenzie Hardy, Marketing Coordinator, Department of Neurosurgery