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Virus Therapy
Neural Stem Cell Virotherapy for Brain Cancer
Phase 1
Recruiting
Led By Jana L Portnow
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer treatment consisting of neural stem cells that carry a virus. The hope is that this will kill more tumor cells than the current standard of care.
Who is the study for?
This trial is for adults with high-grade gliomas that have returned after treatment. Candidates must have adequate blood counts, organ function, and be at least 6 weeks past certain chemotherapies. They need surgery for tumor resection, not be pregnant or breastfeeding, use contraception if applicable, and cannot have specific HLA antibodies or active CNS infections.
What is being tested?
The trial tests multiple doses of NSC-CRAd-S-pk7 on patients with recurrent high-grade gliomas. This therapy uses neural stem cells carrying a virus to target and kill cancer cells during the patient's surgery for tumor resection.
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to viral components in the treatment, typical risks associated with surgical procedures like infection or bleeding, as well as any unforeseen complications from introducing modified stem cells into the body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Secondary study objectives
Changes in HSPG and survivin expression
Body Weight Changes
Changes in tumor growth
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (NSC-CRAd-S-pk7)Experimental Treatment2 Interventions
Patients undergo standard of care surgical resection. Patients then receive NSC-CRAd-S-pk7 intracerebrally over 10 minutes QW for up to 4 doses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resection
2020
Completed Phase 2
~1440
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,544 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,024 Total Patients Enrolled
Jana L PortnowPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
83 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must stop taking any targeted medication for at least 2 weeks before participating in the study.You are currently pregnant or breastfeeding.You require surgery to remove the tumor.You have another type of cancer that is currently being treated.You haven't taken bevacizumab for at least 4 weeks.You are currently taking radiation, chemotherapy or any other experimental medication.You currently have an illness that is not under control, including an ongoing or active infection.You are expected to live for at least three more months.You are not able to have a brain MRI.The neurosurgeon believes that after the tumor is removed, there will be no physical connection between the space where the tumor was and the fluid-filled spaces in the brain.You have received treatment with neural stem cells before.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (NSC-CRAd-S-pk7)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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