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NU-0129 in Treating Patients With Recurrent Glioblastoma or Gliosarcoma Undergoing Surgery | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

NU-0129 in Treating Patients With Recurrent Glioblastoma or Gliosarcoma Undergoing Surgery

A Phase 0 First-In-Human Study Using NU-0129: A Spherical Nucleic Acid (SNA) Gold Nanoparticle Targeting BCL2L12 in Recurrent Glioblastoma Multiforme or Gliosarcoma Patients

NCT03020017•Northwestern University

View on ClinicalTrials.gov

Summary

The purpose of this research study is to evaluate the safety of the study drug, NU-0129, based on Spherical Nucleic Acid (SNA) platform when infused in patients with recurrent glioblastoma multiforme or gliosarcoma. The SNA consists of nucleic acids arranged on the surface of a small spherical gold nanoparticle. This is a first-in-human trial to determine the safety of NU-0129. NU-0129 can cross the blood brain barrier (a filtering mechanism that carry blood to the brain). Once within the tumor, the nucleic acid component is able to target a gene called Bcl2L12 that is present in glioblastoma multiforme, and is associated with tumor growth. This gene prevents tumor cells from apoptosis, which is the process of programmed cell death, thus promoting tumor growth. Researchers think that targeting the Bcl2L12 gene with NU-0129 will help stop cancer cells from growing.

Detailed Description

PRIMARY OBJECTIVES: I. To assess the safety of intravenous NU-0129 in patients with recurrent glioblastoma multiforme (GBM) or gliosarcoma (GS). SECONDARY OBJECTIVES: I. To analyze drug concentration in serum at specific time points after drug administration. II. To demonstrate intratumoral penetration of NU-0129. III. To assess the feasibility of giving NU-0129 as a standard treatment for recurrent GBM or GS. TERTIARY OBJECTIVES: I. To analyze tumor tissue for Bcl2L12 expression levels after NU-0129 administration. II. Preliminary response (progression free survival \[PFS\] and overall survival \[OS\] at 6 months; overall response rate \[ORR\]). OUTLINE: Patients receive NU-0129 intravenously (IV) over 20-50 minutes and undergo standard of care tumor resection within 8-48 hours. After completion of study treatment, patients are followed up at 7, 14, 21, and 28 days and then every 84 days for up to 2 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically proven glioblastoma multiforme (GBM) or gliosarcoma (GS)
•Patients must have measurable disease by Response Assessment in Neuro-Oncology (RANO) 2010 criteria at the time of registration (pre-operative)
•Patients must have failed at least one regimen of chemo or radiation therapy; NOTE: There is no limit to the number or types of prior therapy
•The patient must be a candidate for surgical debulking (either subtotal or gross total resection); biopsy-only candidates will not be eligible
•All patients must be capable to voluntarily sign an informed consent indicating that they are aware of the investigational nature of this study prior to registration
•Patients must have a Karnofsky performance status of \>= 70
•Patients must have adequate bone marrow, liver, coagulation and renal function within 7days prior to study registration, as defined below:
•White blood cell count (WBC) \>= 3,000/uL
•Absolute neutrophil count (ANC) \>= 1,500/mm\^3
•Platelet count of \>= 100,000/mm\^3 (Note: Transfusion or growth factor may be used for eligibility outside of 7 days)
+15 more criteria

Exclusion Criteria

•Patients must not have any significant infections or medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate NU-0129
•Patients must not have a history of any other cancer unless they are in complete remission and off of all therapy for that disease for a minimum of 3 years
•* Note: Non-melanoma skin cancer or carcinoma in-situ of the cervix are exceptions and may be permitted after discussion with study quality assurance manager (QAM)
•Patients must not have had radiation therapy within 12 weeks prior to registration
•Patients must not have had prior cancer therapy (including biologic, cytotoxic, and experimental therapies, nitrosoureas, and Gliadel wafers or other surgically implantable antitumor treatment) within 21 days of registration; if questions arise, please ask the principal investigator (PI)
•* NOTE: Patients must not have Novocure within 24 hours
•Hormonal tumor therapies should not be administered within 14 days of registration; exceptions may be discussed with the PI
•Patients must not have symptomatic hypertension

Locations (1)

Northwestern University

Chicago, Illinois, United States

Key Dates

Start Date

May 25, 2017

Primary Completion Date

September 6, 2018

Completion Date

August 19, 2020

Last Updated

August 26, 2022

Enrollment

ACTUAL participants

Conditions

GliosarcomaRecurrent Glioblastoma

Interventions

Laboratory Biomarker Analysis

OTHER

Pharmacological Study

OTHER

Targeted Molecular Therapy

DRUG

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

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Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

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RECRUITINGPHASE1

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

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AstrocytomaGlioma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 26, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

NU-0129 in Treating Patients With Recurrent Glioblastoma or Gliosarcoma Undergoing Surgery

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue

Study of Pembrolizumab and M032 (NSC 733972)

Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM

A Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma