Clinical Trial: DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase 1b, Randomized, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) and Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosa

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: DNAtrix, Inc.

Current Primary Outcome: Objective response rate (ORR) determined by MRI scan review [ Time Frame: 1.5 years ]

Interval tumor size change will be measured


Original Primary Outcome: Objective Response Rate (ORR) [ Time Frame: 1.5 years ]

Current Secondary Outcome:

  • Incidence and severity of adverse events, including changes in laboratory test results and neurological examination findings [ Time Frame: 1.5 years ]
    Events are classified using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
  • Number of subjects with immunological and biological effects after DNX-2401 with Interferon gamma [ Time Frame: 1.5 years ]
    Laboratory test results and other assessments will be utilized to determine effects
  • 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 ]


Original Secondary Outcome:

  • Number of participants with Adverse Events [ Time Frame: 1.5 years ]
  • Individual responses to treatment, overall and per study arm assignment [ Time Frame: 1.5 years ]
  • Quality of life questionnaire responses [ Time Frame: 1.5 years ]
  • Changes in steroid use (e.g., dose, frequency, duration) [ Time Frame: 1.5 years ]
  • Number of progression-free months [ Time Frame: 1.5 years ]


Information By: DNAtrix, Inc.

Dates:
Date Received: July 20, 2014
Date Started: August 2014
Date Completion:
Last Updated: December 7, 2016
Last Verified: December 2016