NU-0129 in Treating Patients With Recurrent Glioblastoma or Gliosarcoma Undergoing Surgery
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Targeted Molecular Therapy
Early Phase 1
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||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|
- Incidence of Adverse Events [ Time Frame: Up to 28 days after study drug administration ]To evaluate the safety of intravenous NU-0129 in patients with recurrent GBM or GS, the number of adverse events will be assessed and will be graded according to the NCI's Common Terminology Criteria in Adverse Events (CTCAE) version 4.03.
- Drug concentration in blood after drug administration [ Time Frame: At 1, 3, 5, 10, 30, and 60 minutes, and 4, 8, and 24 hours post infusion ]Blood samples will be collected post-infusion to analyze drug concentration at specific time points after drug administration.
- Biodistribution of NU-0129 in tumor tissue [ Time Frame: Up to 2 years ]Tissue will be collected during the scheduled surgery and assayed with Inductively Coupled Plasma Mass Spectrometry (ICPMS) to analyze the concentration of particles in various parts of tumor tissue.
- Feasibility of giving NU-0129 as a standard treatment [ Time Frame: Up to 2 years ]Feasibility will be calculated as the rate of successful production, delivery, and administration of the investigational product and subsequent resection.
|Actual Study Start Date:||May 4, 2017|
|Estimated Study Completion Date:||July 2022|
|Estimated Primary Completion Date:||July 2019 (Final data collection date for primary outcome measure)|
Experimental: Treatment (NU-0129)
Patients receive NU-0129 IV over 20-50 minutes and undergo standard of care tumor resection within 8-48 hours.
Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
Correlative studiesDrug: Targeted Molecular Therapy
Given NU-0129 IV
Other Name: molecularly targeted therapy
I. To assess the safety of intravenous NU-0129 in patients with recurrent glioblastoma multiforme (GBM) or gliosarcoma (GS).
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.
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]).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03020017
|Contact: Study Coordinator||(312)firstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Priya U. Kumthekar, MD 312-503-1818 email@example.com|
|Principal Investigator: Priya U. Kumthekar, MD|
|Sub-Investigator: Karan Dixit, MD|
|Sub-Investigator: Sean Grimm, MD|
|Sub-Investigator: James Chandler, MD|
|Sub-Investigator: Orin Bloch, MD|
|Sub-Investigator: Matt Tate, MD, PhD|
|Sub-Investigator: Macej Lesniak, MD, PhD|
|Sub-Investigator: Margaret Schwartz, NP|
|Sub-Investigator: Lynnette Onuselogu, NP|
|Sub-Investigator: Valerie Nelson, MD, MBA|
|Principal Investigator:||Priya Kumthekar, MD||Northwestern University|