Brain Slice Explants to Predict Drug Response in Brain Tumors

Central Nervous System Tumor Clinical Trial

Official title:

A Feasibility Study to Determine if a Novel Patient-derived Explant Platform Can Produce Drug Sensitivity Scores Within a Clinically Relevant Time Frame in Patients With CNS Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978557
• Other study ID #: LCCC2212
• Status: Recruiting
• Start date: July 27, 2023
• Est. completion date: March 1, 2028

Study information

• Verified date: August 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Devin McCarthy
• Phone: 919-966-7654
• Email: devin_mccarthy[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This biospecimen collection study will evaluate the feasibility of engrafting and testing resected Central nervous system (CNS) tumors tumor tissue ex vivo to estimate drug response, in pediatric and adult subjects. CNS tumors display remarkable heterogeneity and unfortunately there are no reliable precision oncology platforms that can identify the most effective therapy for each patient. Recent work has demonstrated the success of functional precision oncology platforms using patient-derived explant (PDE) at predicting drug response in various cancers. Since PDEs maintain important aspects of tumor heterogeneity they may prove effective as functional models for CNS tumors. The purpose of this study is to explore the feasibility of using a novel PDE platform to generate drug sensitivity scores from patients with central nervous system tumors in Pediatric and adult subjects having low- or high-grade CNS tumors resected. The secondary objective is to estimate the proportion of successfully scaled PDEs generated per given tumor size.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

1. Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information or written assent and parental consent for pediatric subjects or surrogate consent provided by the subject's legally authorized guardians.

2. A diagnosis of a tumor residing in the central nervous system with surgery plan to have surgical resection.

3. The subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designer.

Exclusion Criteria:

1. All subjects must not meet any of the following exclusion criteria prior to enrollment to participate in this study:

Any serious medical or psychiatric disorder that would interfere with the subject's ability to give informed consent.

2. Incarcerated individuals.

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Central Nervous System Tumor
• Nervous System Neoplasms

Intervention

Other:
• Biospecimen collection
Biospecimen will be collected during surgery.

Locations

Country	Name	City	State
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of specimens yielding scores	The proportion of evaluable specimens yielding patient-derived explant (PDE) drug sensitivity scores. Specimens will be collected during surgery for tumor resection. Excised specimens will be processed to generate PDE-based functional drug screening models. A panel of therapeutics will be chosen for each specimen according to pre-set criteria determined.	Up to 28 days
Secondary	The scalability of evaluable specimens	The percentage of evaluable specimens amenable to proportionally scaled patient-derived explant (PDE) generation per specimen size will be studied.	Up to 28 days

External Links

•   University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials