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Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03072134
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Maciej Lesniak, Northwestern University

Tracking Information
First Submitted Date  ICMJE February 20, 2017
First Posted Date  ICMJE March 7, 2017
Last Update Posted Date April 8, 2020
Actual Study Start Date  ICMJE April 24, 2017
Actual Primary Completion Date April 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma
Official Title  ICMJE Neural Stem Cell Oncolytic Adenoviral Virotherapy of Newly Diagnosed Malignant Glioma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Glioma
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Anaplastic Oligoastrocytoma
  • Glioblastoma Multiforme
  • Astrocytoma, Grade III
  • Astrocytoma, Grade IV
  • Brain Cancer
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Neural stem cells loaded with an oncolytic adenovirus
  • 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.
    Intervention: Biological: Neural stem cells loaded with an oncolytic adenovirus
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2020)
13
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2017)
36
Actual Study Completion Date  ICMJE April 6, 2020
Actual Primary Completion Date April 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03072134
Other Study ID Numbers  ICMJE STU00203933
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maciej Lesniak, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maciej S Lesniak, MD Northwestern University
PRS Account Northwestern University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP