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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 : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Northwestern University

February 20, 2017
March 7, 2017
September 6, 2018
April 24, 2017
March 30, 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03072134 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma
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.
Not Provided
Interventional
Phase 1
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
  • 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
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: 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
Same as current
April 1, 2019
March 30, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Maciej S Lesniak, MD 312-926-1094 maciej.lesniak@northwestern.edu
Contact: Christina Amidei, RN 312-926-1094 christina.amidei@northwestern.edu
United States
 
 
NCT03072134
STU00203933
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Northwestern University
Northwestern University
Not Provided
Principal Investigator: Maciej S Lesniak, MD Northwestern University
Northwestern University
September 2018

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