Work

Ept-10phase I Clinical Trial of Hsv G207 Alone or With a Single Radiation Dose in Children With Recurrent Supratentorial Brain Tumors (nct02457845)

Year: 2016

Type: article

Abstract: Outcomes for children with recurrent malignant supratentorial brain tumors are extremely poor. Novel innovative treatments are greatly needed. A first-generation genetically engineered, oncolytic herpes simplex virus (oHSV), G207, has shown tumor specific tropism, safety and potential efficacy in the treatment of malignant brain tumors in adults. It contains deletions of both copies of the γ134.5 “neurovirulence” gene and is a promising, innovative approach due to enhanced sensitivity of pediatric brain tumor cells. Children 3-18 years old with progressive or recurrent malignant supratentorial brain tumor after initial surgery, radiotherapy, and/or chemotherapy are eligible. Patients with brainstem, cerebellar or intraventricular tumors are ineligible. After stereotactic biopsy to confirm tumor recurrence, 1-4 silastic catheters will be passed to predefined coordinates of enhancing tumor. Subsequently, G207 will be slowly infused over 6 hours at one of two doses only or followed by a single 5 Gy fraction of radiation within 24 hours. The primary objective is to assess the safety (3 + 3 design) and tolerability of G207 alone or followed by radiation. Secondary aims are to evaluate any potential efficacy of, and biological responses to G207 alone or combined with radiation. We will assess radiographic response, neurologic performance, progression-free/overall survivals, immune responses, and presence of G207 in blood, saliva, and conjunctival secretions. Correlative tumor genotype and phenotype studies designed to identify patients most likely to respond to oHSV and quality of life studies will be performed. This is the first-ever study of intratumorally infused oHSV alone or combined with radiotherapy in children with brain cancer.

Source: Neuro-Oncology

DOI: 10.1093/neuonc/now069.09