NU-0129 in Treating Patients With Recurrent Glioblastoma or Gliosarcoma Undergoing Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03020017|
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : May 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gliosarcoma Recurrent Glioblastoma||Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Targeted Molecular Therapy||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 4, 2017|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2022|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|