Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03072134 : Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Patients must have presumed malignant glioma based on clinical and radiologic
evaluation (pathologic confirmation of malignant glioma must be made at the time of
stereotactic biopsy or resection prior to NSC-CRAd-S-pk7 injection; if this is not
possible, the injection will not be performed and the subject will no longer be
eligible for the study).

- Tumor must be accessible for injection and must not be located in the brainstem, or
contained within the ventricular system.

- Planning to undergo standard radiation/chemotherapy

- 18 years of age or older.

- Performance status must be KPS = 70

- SGOT (AST) < 3x upper limit of normal

- Serum creatinine < 2mg/dl

- Platelets > 100,000/mm3 and WBC > 3000/mm3

Exclusion Criteria:

- Prior or ongoing liver disease including known cirrhosis, hepatitis B or C infection
but not to exclude patients with a distant history of resolved hepatitis A infection.

- Immunosuppressive drugs (with exception of corticosteroid).

- Known HIV+ patients.

- Acute infections (viral, bacterial or fungal infections requiring therapy).

- Pregnant or breast-feeding patients.

- Evidence of metastatic disease or other malignancy (except squamous or basal cell skin
cancers).

- Prior radiation therapy to the brain or prior treatment for brain tumor Other serious
co-morbid illness or compromised organ function.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03072134      |      Link to official Clinicaltrials.gov listing
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