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

• Status: Completed
• Trial end date: 2018-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DNAtrix, Inc.
• Treatments: Interferon-gamma; Interferons

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