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

NCT ID: NCT02197169

Last Updated: 2018-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-11
• Study Completion Date: 2018-03-15

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 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.

Conditions

Glioblastoma or Gliosarcoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DNX-2401 alone

Single intratumoral injection of DNX-2401

Group Type: EXPERIMENTAL

Single intratumoral injection of DNX-2401

Intervention Type: 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.

DNX-2401 + Interferon gamma (IFN-γ)

Interferon gamma (IFN-γ) beginning at Day 14

Group Type: EXPERIMENTAL

Single intratumoral injection of DNX-2401

Intervention Type: 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.

Interferon-gamma

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Oncolytic virus; Genetically-modified adenovirus; Actimmune; immunotherapy; gamma interferon

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DNAtrix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nam Tran, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Karen Fink, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor University: Charles A. Sammons Cancer Center

Vinay Puduvalli, MBBS

Role: PRINCIPAL_INVESTIGATOR

Ohio State University: James Cancer Center

Frederick Lang, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

The Ohio State University

Columbus, Ohio, United States

Baylor University: Charles A. Sammons Cancer Center

Dallas, Texas, United States

UT MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

2401BT-IFN-001

Identifier Type: -

Identifier Source: org_study_id