Overview
DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors
Status:
Completed
Completed
Trial end date:
2018-03-15
2018-03-15
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
NoDetails
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