Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT02197169
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02197169
Study Brief:
Protocol Section:
NCT02197169