DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/18/2018 |
| Start Date: | September 11, 2014 |
| End Date: | March 15, 2018 |
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)
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.
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.
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.
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.
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
We found this trial at
4
sites
281 W. Lane Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Vinay K Puduvalli, MBBS
Phone: 614-685-2435
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Houston, Texas 77030
Principal Investigator: Frederick F Lang, MD
Phone: 713-792-2400
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