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Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma

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ClinicalTrials.gov Identifier: NCT03072134
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Maciej Lesniak, Northwestern University

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 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
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : April 1, 2020


Arm Intervention/treatment
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.
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

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 :
  1. 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 :
  1. 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


Contacts
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Contact: Maciej S Lesniak, MD 312-926-1094 maciej.lesniak@northwestern.edu
Contact: Christina Amidei, RN 312-926-1094 christina.amidei@northwestern.edu

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Jana Portnow, MD    626-359-8111    jportnow@coh.org   
Principal Investigator: Jana Portnow         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Christina Amidei, RN, PhD       christina.amidei@northwestern.edu   
Contact: Maciej Lesniak, MD    3129261094 ext Lesniak    maciej.lesniak@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Maciej S Lesniak, MD Northwestern University

Publications:

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Responsible Party: Maciej Lesniak, Professor and Chairman, Northwestern University
ClinicalTrials.gov Identifier: NCT03072134     History of Changes
Other Study ID Numbers: STU00203933
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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