Chair:  Brad Elder, MD  
Co-Chair: Gavin Dunn, MD, PhD, FAANS
Members: Dan Cahill, MD, PhD, FAANS, Melanie Hayden Gephart, MD, FAANS, Mark Linskey, MD, FAANS, Timothy Smith, MD, PhD, FAANs, Andrew Sloan, MD, FAANS, and Michael Vogelbaum MD, PhD, FAANS

From the “Clinical Trials and Registries” Committee, we are excited to provide updates on important tumor registry and highlight clinical trial activity.

NeuroPoint Alliance

Background:

The NeuroPoint Alliance (NPA) was established in 2008 to improve quality of care for neurosurgical patients through acquisition and analysis of clinical outcomes data. The goals of the NPA include:

• Establish risk-adjusted national benchmarks for both the safety and effectiveness of neurosurgical and spine procedures.
• Allow practice groups and hospitals to analyze their individual morbidity and clinical outcomes in real-time.
• Generate both quality and efficacy data to support claims made to public and private payers.
• Demonstrate the comparative effectiveness of neurosurgical procedures.
• Facilitate essential multi-center trials and other cooperative clinical studies.
• Publication of data in peer reviewed journals (to date, the data has supported production of >100 manuscripts).

Tumor QOD

The NPA QOD Tumor Registry was developed in collaboration with the AANS/CNS Tumor Section Executive Committee and opened in April 2021 after a one-year pilot study. The Tumor Section focuses on outcomes for intracranial tumor procedures. Participating sites enter outcomes data online through RedCap. Mayo Clinic is the coordinating center and provides data management, analysis and clinical and scientific guidance. The QOD Tumor Registry Steering Committee convened in 2021 provides strategic direction of the registry, provides content expertise, guidance and promotion of program activities. A quarterly report is provided to enrolling centers which gives a breakdown of demographics, case mix and outcomes in comparison to overall tumor registry data.

Tumor Registry Steering Committee:

• E. Antonio Chiocca – Chair
• Mark Shaffrey – NPA Data Operations Committee
• Timothy Smith – NPA Data Use Committee
• Randy Jensen – Tumor Section
• Linda Liau – NREF
• Shawn Hervey-Jumper – Young Neurosurgeons Committee
• Fred Barker – NPA Board of Directors
• Carl Heilman – Key Opinion Leader

Participating in the Tumor QOD Registry

Participating institutes can include academic medical centers, hospitals, ambulatory surgery centers, healthcare systems, private practice groups and individual surgeons. The startup process includes registration, training, and onboarding, and is followed by continuous site support and monitoring.

The current price point is a three-year contract at $5,000/year registration fees plus funding of a 0.5 FTE for data entry. The number of centers active and in contract is increasing.

Those interested in more information regarding participating in the NPA Tumor QOD should contact: Irene Zyung; Senior Manager, Registry Operations;
Email: izyung@neuropoint.org; Phone: 847-378-0549

Alliance for Clinical Trials in Oncology

In this report, we highlight an Alliance study, “A study testing the effect of immunotherapy (Ipilimumab and Nivolumab) in patients with recurrent glioma with elevated mutational burden”.  In anywhere between 14-20% of patients with recurrent high-grade glioma (glioblastoma, IDH wild type or astrocytoma, IDH mutant, grade 4) exhibit a much higher mutational burden than is usually seen in these diseases. Elevated mutational burden has been shown to be an important biomarker of response to checkpoint blockade immunotherapy in other cancers, but it is not clear whether this correlation exists in malignant gliomas. This Phase II study therefore tests the hypothesis that patients with high mutational burden recurrent disease will demonstrate improved responses to immunotherapy. Eligible patients are those with first or second recurrences, and tissue obtained — via biopsy or craniotomy — at the time of recurrence is analyzed for mutational burden to determine eligibility for enrollment. Target enrollment is 32 patients in a two-stage design; 10 patients are enrolled in the first 18 patient cohort. Study chairs are Gavin Dunn, MD, PhD, FAANS, Evanthia Galanis, MD, and David Reardon, MD. Feel free to contact Gavin at gpdunn@mgh.harvard.edu.

Further information regarding this clinical trial can be obtained from the Alliance website at allianceforclinicaltrialsinoncology.org or clinicaltrials.gov. A list of ongoing trials sponsored by the Alliance can be accessed via the Alliance website.

The Fall Alliance for Clinical Trials in Oncology meeting is a hybrid in person/virtual meeting Saturday, November 5, 2022, in Chicago, IL.