Led by UNC Lineberger’s Soma Sengupta, MD, PhD, MBA, division chief of neuro-oncology in the UNC Department of Neurosurgery, this phase 2 trial will evaluate the optimal dose of Ropidoxuridine to enhance the positive effect of radiation therapy for patients with unmethylated MGMT glioblastoma.
The UNC Lineberger Comprehensive Cancer Center at the UNC School of Medicine is now enrolling patients in a multicenter clinical trial evaluating a radiation sensitizer drug for patients diagnosed with the most aggressive brain tumors. The phase 2 clinical trial will evaluate the optimal dose of a drug called Ropidoxuridine (IPdR), developed by Shuttle Pharma, for treating patients with glioblastoma (GBM).
IPdR is a radiation sensitizer, which is a drug used to enhance the effects of radiation, and will be used in combination with radiation therapy. Notably, the FDA has granted a “Safe to Proceed” letter in response to the IND application of a phase 2 study evaluating IPdR as a radiation-sensitizing agent during radiotherapy in patients with newly diagnosed IDH-wildtype GBM with unmethylated MGMT promoter status earlier this year.
The clinical trial will initially consist of 40 randomized patients separated into two doses of IPdR to determine the optimal dose. Once the optimal dose is established, 14 additional patients will join the study and be given the optimal dose. The trial will be completed over a period of 18 to 24 months.
The site’s principal investigator and Division Chief of Neuro-Oncology, physician-scientist Soma Sengupta, MD, PhD, MBA, who is also the Vice Chair of Research in the Department of Neurosurgery and Clinical Professor in the Department of Neurology. “There is an unmet need for theranostic therapies in MGMT unmethylated GBMs, and IPdR is a prodrug that holds promise as a radiosensitizer in a number of cancers,” said Sengupta.
An estimated 800,000 patients in the United States are treated with radiation therapy for cancer each year. According to the American Cancer Society and the American Society of Radiation Oncologists, about 50% of those patients are treated for curative purposes. Radiation sensitizers may benefit the 400,000 patients treated for curative purposes, with this number expected to grow more than 22% over the next five years.
There is currently no known cure for glioblastoma. The average survival time for patients with glioblastoma is 12 to 18 months, with a 5-year survival rate of only 5-7%. Glioblastoma is a complex, treatment-resistant cancer, but early treatments can control the tumor’s growth for months or even years. UNC Health and the UNC Lineberger Comprehensive Cancer Center are actively involved in ongoing brain tumor research and brain tumor clinical trials evaluating new treatment options for this deadly disease.
About Shuttle Pharmaceuticals
Founded in 2012 by Georgetown University Medical Center faculty members, Shuttle Pharma is developing first-in-class therapies focused on curing cancer and improving the outcomes for cancer patients treated with radiation therapy. Their mission is to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of radiation therapy while limiting the side effects of radiation in cancer treatment.
If you are interested in joining the study, please contact our research coordinator, Camisha Johnson, at 919-445-4847 or by email at camisha_johnson@med.unc.edu.
Written by Makenzie Hardy, Marketing Coordinator, Department of Neurosurgery