Clinical Trial Details
Braintumor Website

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NCT02197169 : DNX-2401 With Interferon Gamma (IFN-?) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors
PhasePhase 1
AgesMin: 18 Years Max: N/A
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
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