A Phase 1 interventional study of Single intratumoral injection of DNX-2401 and Interferon-gamma in Glioblastoma or Gliosarcoma, sponsored by DNAtrix, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-16.
Sponsored by DNAtrix, Inc. · Phase 1, Interventional, and Treatment
Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of malignant primary brain tumor in adults and can be resistant to conventional therapies. The purpose of this Phase Ib study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor responds to one injection of DNX-2401, a genetically modified, conditionally replicative and oncolytic human-derived adenovirus. DNX-2401 is delivered directly into the tumor where it may establish an active infection by replicating in and killing tumor cells.
Enrollment has been completed for the randomized portion of the study with ongoing evaluation of tumor response and safety. No additional subjects will be randomized or receive interferon gamma (IFN-γ).
The non-randomized portion of the study is open for screening and enrollment. Eligible subjects will receive a single intratumoral injection of DNX-2401 into a recurrent glioblastoma or gliosarcoma brain tumor using the Alcyone MEMS Cannula (AMC™) System (cannula). Tumor response and safety will be evaluated.
After receiving DNX-2401, subjects will return to the clinic for study visits at regular intervals for safety monitoring, MRI scans and other assessments for up to 18 months. Thereafter, they will be followed closely for safety and survival.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 37 is close to the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →DNAtrix, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply as outlined in the relevant protocol version
Single intratumoral injection of DNX-2401
Drug: Single intratumoral injection of DNX-2401
Interferon gamma (IFN-γ) beginning at Day 14
Drug: Single intratumoral injection of DNX-2401 · Drug: Interferon-gamma
In the randomized group, following brain tumor biopsy and histological confirmation of recurrent glioblastoma/gliosarcoma, a single injection of DNX-2401 was administered directly into the brain tumor with or without subsequent interferon gamma (IFN-γ) No additional subjects will be randomized. A single intratumoral dose of DNX-2401 will be delivered by cannula.
Also known as: Oncolytic virus, Genetically-modified adenovirus
In the randomized group, a single injection of DNX-2401 was followed by interferon gamma (IFN-γ). No additional subjects will be randomized or receive IFN-γ following DNX-2401
Also known as: Actimmune, immunotherapy, gamma interferon
Objective response rate (ORR) determined by MRI scan review
Interval tumor size change will be measured
Time frame: 1.5 years
Incidence and severity of adverse events, including changes in laboratory test results and neurological examination findings
Events are classified using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time frame: 1.5 years
Number of subjects with immunological and biological effects after DNX-2401 with Interferon gamma
Laboratory test results and other assessments will be utilized to determine effects
Time frame: 1.5 years
Changes in steroid use (dose and frequency) and clinical and KPS status overall and per study arm assignment
Time frame: 1.5 years
Overall survival (OS), progression-free survival (PFS), and clinical benefit rate (CBR).
Time frame: 1.5 years
Changes in responses to quality of life questionnaires
Time frame: 1.5 years
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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DNAtrix, Inc.