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NCT Number: NCT02197169

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

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.

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Key information

Conditions

Glioblastoma or Gliosarcoma Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioblastoma Glioma Gliosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Moffitt Cancer Center, Tampa, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single intratumoral injection of DNX-2401

Drug

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

interferon-gamma

Drug

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

Primary outcomes

  1. Objective response rate (ORR) determined by MRI scan review

    Time frame: 1.5 years

    Interval tumor size change will be measured

Secondary outcomes

  1. 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

  2. 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

  3. Changes in steroid use (dose and frequency) and clinical and KPS status overall and per study arm assignment

    Time frame: 1.5 years

  4. Overall survival (OS), progression-free survival (PFS), and clinical benefit rate (CBR).

    Time frame: 1.5 years

  5. Changes in responses to quality of life questionnaires

    Time frame: 1.5 years

Sponsors and collaborators

Lead sponsor

DNAtrix, Inc.

Industry

Registry information

Official study 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 Gliosarcoma (TARGET-I)

Acronym: TARGET-I

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 22, 2014
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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