Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma
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| ClinicalTrials.gov Identifier: NCT03072134 |
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Recruitment Status :
Active, not recruiting
First Posted : March 7, 2017
Last Update Posted : October 14, 2020
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Sponsor:
Northwestern University
Information provided by (Responsible Party):
Maciej Lesniak, Northwestern University
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Brief 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 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glioma Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Glioblastoma Multiforme Astrocytoma, Grade III Astrocytoma, Grade IV Brain Cancer | Biological: Neural stem cells loaded with an oncolytic adenovirus | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 13 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | A Phase I study of neural stem cell based virotherapy in combination with standard radiation and chemotherapy for patients with newly diagnosed malignant glioma |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Neural Stem Cell Oncolytic Adenoviral Virotherapy of Newly Diagnosed Malignant Glioma |
| Actual Study Start Date : | April 24, 2017 |
| Actual Primary Completion Date : | April 6, 2020 |
| Estimated Study Completion Date : | December 31, 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Unresectable disease
Patients with unresectable tumors will undergo a biopsy followed by injection of neural stem cells loaded with the virus and then receive standard chemoradiotherapy.
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Biological: Neural stem cells loaded with an oncolytic adenovirus
The primary objectives are to evaluate the safety of the combined therapy and determine the maximum tolerated dose (MTD) for a future Phase II study.
Other Name: NSC-CRAd-Survivin-pk7 |
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Experimental: Resectable disease
Patients with resectable tumors will undergo a resection followed by injection of neural stem cells loaded with the virus and then receive standard chemoradiotherapy.
|
Biological: Neural stem cells loaded with an oncolytic adenovirus
The primary objectives are to evaluate the safety of the combined therapy and determine the maximum tolerated dose (MTD) for a future Phase II study.
Other Name: NSC-CRAd-Survivin-pk7 |
Primary Outcome Measures :
- Determine the maximum number of neural stem cells loaded with the oncolytic adenovirus. [ Time Frame: Two years ]We will escalate the number of neural stem cells loaded with the oncolytic adenovirus in each cohort of patients and monitor the neurological exam for development of any neurological side effects.
Secondary Outcome Measures :
- Assessment of tumor response or progression to treatment on MRI. [ Time Frame: Two years ]We will monitor patients with serial MRIs over the course of the study to determine whether there is any evidence of tumor regression or progression.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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) < 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072134
Locations
| United States, California | |
| City of Hope | |
| Duarte, California, United States, 91010 | |
| United States, Illinois | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
Sponsors and Collaborators
Northwestern University
Investigators
| Principal Investigator: | Maciej S Lesniak, MD | Northwestern University |
Publications:
| Responsible Party: | Maciej Lesniak, Professor and Chairman, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT03072134 |
| Other Study ID Numbers: |
STU00203933 |
| First Posted: | March 7, 2017 Key Record Dates |
| Last Update Posted: | October 14, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Maciej Lesniak, Northwestern University:
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Glioma Glioblastoma Astrocytoma Brain Cancer New Diagnosed Glioma Temozolomide |
Radiation Neural Stem Cells Virotherapy Adenovirus Oncolytic virotherapy |
Additional relevant MeSH terms:
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Glioblastoma Glioma Astrocytoma Oligodendroglioma Brain Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |