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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:
ClinicalTrials.gov Identifier:
NCT02197169
First Posted: July 22, 2014
Last Update Posted: December 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DNAtrix, Inc.
  Purpose
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.

Condition Intervention Phase
Glioblastoma or Gliosarcoma Drug: Single intratumoral injection of DNX-2401 Drug: Interferon-gamma Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Gliosarcoma (TARGET-I)

Resource links provided by NLM:


Further study details as provided by DNAtrix, Inc.:

Primary Outcome Measures:
  • Objective response rate (ORR) determined by MRI scan review [ Time Frame: 1.5 years ]
    Interval tumor size change will be measured


Secondary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: August 2014
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DNX-2401 alone
Single intratumoral injection of DNX-2401
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
Experimental: DNX-2401 + Interferon gamma (IFN-γ)
Interferon gamma (IFN-γ) beginning at Day 14
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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197169


Locations
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
Baylor University: Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
DNAtrix, Inc.
Investigators
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
  More Information

Responsible Party: DNAtrix, Inc.
ClinicalTrials.gov Identifier: NCT02197169     History of Changes
Other Study ID Numbers: 2401BT-IFN-001
First Submitted: July 20, 2014
First Posted: July 22, 2014
Last Update Posted: December 9, 2016
Last Verified: December 2016

Keywords provided by DNAtrix, Inc.:
Brain
Brain Cancer
Brain Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
CNS
Conditionally Replication-Competent Adenovirus
DNX-2401
Delta-24-RGD
Glioma
Glioblastoma
Gliosarcoma
Interferon gamma
Malignant brain tumor
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Nervous System Diseases
Alcyone Lifesciences
AMC™
Cannula
Alcyone MEMS Cannula (AMC™) System

Additional relevant MeSH terms:
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents