Phase 1
Completed N=3
Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma
Glioma · Anaplastic Astrocytoma · Brain Cancer · Anaplastic Oligoastrocytoma
Source: ClinicalTrials.gov NCT03072134 ↗
Enrolled (actual)
3
Serious AEs
25.0%
Results posted
Jan 2023
Primary outcomePrimary: Percentage of Dose-limiting Toxicities — 0; 0; 17 Percentage of dose-limiting toxicities
Summary
Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Based on the encouraging results of our preclinical studies which demonstrate improved efficacy without added toxicity, the paradigm of delivering a novel oncolytic adenovirus via a neural stem cell line in combination with radiation and chemotherapy is well-suited for evaluation in newly diagnosed malignant gliomas. The standard-of-care allows application of virotherapy as neoadjuvant therapy and assessment of the cooperative effects with radiation/chemotherapy without altering the standard treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Dose-limiting Toxicities |
0; 0; 17 | — |
| SECONDARY Assessment of Tumor Response. |
8; 8; 84 | — |
| SECONDARY Progression-free Survival |
9.1 | — |
| SECONDARY Overall Survival |
18.4 | — |
Eligibility Criteria
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) 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.
Data sourced from ClinicalTrials.gov (NCT03072134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.