BTC GBM TeamLab Trial 1: Longitudinal Tissue Profiling of Recurrent Malignant Glioma During Repeat Dosing of Oncolytic Viral Immunotherapy (NCT03152318)

The data in this repository is generated from the work of the GBM TeamLab as part of Break Through Cancer (BTC) (https://breakthroughcancer.org/). The TeamLab's goal is to evaluate the feasibility, safety, and value of performing serial brain biopsies to obtain biological readouts during the assessment of novel glibolastoma (GBM) therapeutics. The first investigational agent studied by the TeamLab is a novel oncolytic viral immunotherapy (agent: CAN-3110, also known as rQNestin34.5v.2) which was delivered via repeated intratumoral delivery at up to 6 timepoints over a 4-month period in recurrent IDH-wild type GBM patients. Biopsy tissues, blood, and CSF were collected and subjected to multi-omic profiling at each surgical timepoint. This work is being conducted as one of the trial arms for NCT03152318. Controlled access omic data from this study will be deposited here as the results are published.]]>
Full inclusion/exclusion criteria can be found in the flagship manuscript for this dataset. A brief listing of important criteria is as follows: Inclusion: • Pathological confirmation of high-grade glioma (specifically IDH wild-type GBM for the patients with data in this dbGaP repository) • Prior diagnosis of glioma • Prior history of external beam radiation and, for MGMT methylated patients with prior history of high-grade glioma, prior history of temzolomide. Radiation and temozolomide treatment must have occurred at least 4 weeks prior to first dose of CAN-3110 • Age >= 18 years Exclusion: • Chronic infection with HIV or hepatitis B or C • Active viral, bacterial, or fungal infection requiring antiviral or antibiotic treatment • Active HSV-1 infection on valacyclovir, acyclovir, or ganciclovir therapy within 7 days prior to CAN-3110 injection • Active oral or genital herpes lesions • Receiving any other investigational agents at time of CAN-3110 injection • Uncontrolled intercurrent illness ]]>
Patient enrollment began in September 2017 for Arms A and B. The data and publication for these patients can be found on dbGaP study accession phs003378. This repository include data from patients from Arm C, which includes two open-label cohorts of 12 subjects. Enrollment began in March 2022 and is still ongoing. ]]>