Phase 2 Trial of G207 + 5 Gy Radiation for Children With High-Grade Gliomas
ConditionHigh Grade Gliomas
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-21
SponsorM.D. Anderson Cancer Center
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patient requires an escalation in ongoing systemic corticosteroid therapy within 7 days prior to G207 inoculation
For this study, 'systemic corticosteroids' include oral, intravenous, or intramuscular formulations. A single, non-consecutive dose does not constitute exclusion. Physiologic corticosteroid replacement therapy (e.g., hydrocortisone for adrenal insufficiency), intermittent use of bronchodilators and topical steroids, is not considered immunosuppressive and does not constitute exclusion.
Trial design
Design model
Single group
Treatments tested in this trial
G207
DrugGiven by injection
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: Treatment with G207 (IT) + 5 Gy RadiationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov