At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed glioblastoma multiforme (GBM) or gliosarcoma (GS)
- ✓Recurrent disease with measurable disease by RANO 2010 criteria
- ✓Failed at least one prior regimen of chemotherapy or radiation therapy (no limit on number or types)
- ✓Candidate for surgical debulking (subtotal or gross total resection); biopsy-only candidates ineligible
- ✕Significant infections or medical illnesses that cannot be adequately controlled or would compromise tolerability of NU-0129
- ✕History of any other cancer unless in complete remission and off therapy for ≥3 years (exceptions: non-melanoma skin cancer, cervical carcinoma in situ)
- ✕Radiation therapy within 12 weeks prior to registration
- ✕Prior cancer therapy (chemotherapy, biologic, cytotoxic, experimental, nitrosoureas, Gliadel, implantable antitumor treatment) within 21 days; Novocure within 24 hours
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Early Phase 1 clinical trial evaluating Laboratory Biomarker Analysis, Pharmacological Study, and 1 other intervention for Gliosarcoma and Recurrent Glioblastoma. Completed, enrolled 8 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Correlative studies
Correlative studies
Given NU-0129 IV