Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Brain Cancer, Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/8/2018 |
| Start Date: | April 24, 2017 |
| End Date: | April 1, 2019 |
| Contact: | Maciej S Lesniak, MD |
| Email: | maciej.lesniak@northwestern.edu |
| Phone: | 312-926-1094 |
Neural Stem Cell Oncolytic Adenoviral Virotherapy of Newly Diagnosed Malignant Glioma
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 diganosed 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.
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 diganosed 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.
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.
We found this trial at
1
site
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
Click here to add this to my saved trials
