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DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors (TARGET-I)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DNAtrix, Inc.
ClinicalTrials.gov Identifier:
NCT02197169
First received: July 20, 2014
Last updated: December 7, 2016
Last verified: December 2016

July 20, 2014
December 7, 2016
August 2014
August 2017   (Final data collection date for primary outcome measure)
Objective response rate (ORR) determined by MRI scan review [ Time Frame: 1.5 years ]
Interval tumor size change will be measured
Objective Response Rate (ORR) [ Time Frame: 1.5 years ]
Complete list of historical versions of study NCT02197169 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors
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 Gliosarcoma (TARGET-I)
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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma or Gliosarcoma
  • Drug: Single intratumoral injection of DNX-2401

    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.

    Other Names:
    • Oncolytic virus
    • Genetically-modified adenovirus
  • Drug: Interferon-gamma
    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
    Other Names:
    • Actimmune
    • immunotherapy
    • gamma interferon
  • Experimental: DNX-2401 alone
    Single intratumoral injection of DNX-2401
    Intervention: Drug: Single intratumoral injection of DNX-2401
  • Experimental: DNX-2401 + Interferon gamma (IFN-γ)
    Interferon gamma (IFN-γ) beginning at Day 14
    Interventions:
    • Drug: Single intratumoral injection of DNX-2401
    • Drug: Interferon-gamma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
37
Not Provided
August 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Glioblastoma or gliosarcoma in first or second recurrence only
  • Documented tumor recurrence or progression after failing prior surgical resection, chemotherapy, or radiation
  • Tumor size greater than or equal to 1.0 cm in two perpendicular diameters
  • Not undergoing surgical resection or for whom gross total resection is not possible
  • Karnofsky Performance Status greater than or equal to 70%

Exclusion Criteria:

  • Multiple intracranial malignant glioma lesions
  • Tumor location or involvement that would result in risk of ventricular penetration during tumor injection
  • Tumor involving both hemispheres or that which involves the subependyma or suspected cerebrospinal fluid dissemination
  • Tumor involving brain stem
  • Documented extracranial metastasis
  • Inability to undergo MRI
  • Pregnant or nursing females
  • Any medical condition that precludes the surgery necessary to administer DNX-2401 into the tumor using the cannula
  • Immunocompromised subjects or those with autoimmune conditions, active hepatitis or positive for human immunodeficiency virus (HIV)
  • Li-Fraumeni Syndrome

Other protocol-defined inclusion/exclusion criteria may apply as outlined in the relevant protocol version

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02197169
2401BT-IFN-001
No
Not Provided
Not Provided
Not Provided
DNAtrix, Inc.
DNAtrix, Inc.
Not Provided
Principal Investigator: Nam Tran, MD, PhD Moffitt Cancer Center
Principal Investigator: Karen Fink, MD, PhD Baylor University: Charles A. Sammons Cancer Center
Principal Investigator: Vinay Puduvalli, MBBS Ohio State University: James Cancer Center
Principal Investigator: Frederick Lang, MD M.D. Anderson Cancer Center
DNAtrix, Inc.
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP