Status:
COMPLETED
DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors
Lead Sponsor:
DNAtrix, Inc.
Conditions:
Glioblastoma or Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2018
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT02197169
Start Date
September 11 2014
End Date
March 15 2018
Last Update
July 16 2018
Active Locations (4)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
2
The Ohio State University
Columbus, Ohio, United States, 43210
3
Baylor University: Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
4
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030