High Grade Gliomas
Conditions
Brief summary
The goal of this clinical research study is to learn about the safety and effects of G207 combined with radiation therapy in patients with recurrent or progressive high-grade glioma (HGG).
Detailed description
Primary Objective: To assess the efficacy of G207 administered intratumorally followed by 5 Gy radiation within 24hours in patients with recurrent or progressive high-grade glioma (HGG) as measured by postprogression overall survival (pp-OS), focused on patients with one progression following their priorsurgery and radiotherapy, compared to matched historical controls. Secondary Objectives: To describe the pp-OS survival in patients treated with G207 + 5 Gy with more than one progression following their prior surgery and radiotherapy To establish safety and characterize toxicity of G207 + 5 Gy radiation To survey for virologic shedding following G207 To evaluate immunologic response(s) to G207 To assess radiographic changes from baseline by RANO 2.0 criteria and by tumor volume, cerebral blood volume, and apparent diffusion coefficient. To describe the efficacy of G207 + 5 Gy radiation as measured by response rate and progressionfree survival (PFS) Exploratory Objectives: To assess performance status score changes over time after treatment with G207 + 5 Gy radiation To evaluate pre- and post-treatment tissue for immune cell populations and checkpoint proteins in patients who are amendable to and meet criteria for resection/biopsy while on study To assess OS in subgroups of patients based on therapies received after G207 + 5 Gy radiation (surgery versus no surgery; reirradiation versus no reirradiation, immunotherapy versus no immunotherapy)
Interventions
DRUGG207
Given by injection
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 21 Years
Healthy volunteers
No
Exclusion criteria
Pregnancy Pregnant women are excluded from this study. Female patients of childbearing potential must have a negative serum or urine pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Pregnant women are excluded from this study because G207 is an agent with the potential for teratogenic or abortifacient effects. Lactation Status Lactating females are not eligible unless they have agreed not to breastfeed their infants Because there is an unknown potential risk for adverse events in nursing infants secondary to treatment of the mother with G207, breastfeeding should be discontinued if the mother is treated with G207. Disease-Related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTGregory Friedman, MD
PRINCIPAL_INVESTIGATORGregory Friedman, MD
UT MD Anderson
Outcome results
None listed